1. PRESS RELEASE

    Immunocore and Medison Pharma Partner for Future Commercialization of Tebentafusp in Canada, Central Eastern Europe, and Israel

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US and PETACH TIKVAH, Israel, October 18, 2021) -- Immunocore (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease, and Medison Pharma Ltd., a global pharma company focused on providing access to highly innovative therapies to patients in international markets, today announced an exclusive multi-regional agreement for Medison to help seek regulatory authorization…

    PRESS RELEASE

    Immunocore and Medison Pharma Partner for Future Commercialization of Tebentafusp in Canada, Central Eastern Europe, and Israel

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US and PETACH TIKVAH, Israel, October 18, 2021) -- Immunocore (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease, and Medison Pharma Ltd., a global pharma company focused on providing access to highly innovative therapies to patients in international markets, today announced an exclusive multi-regional agreement for Medison to help seek regulatory authorization and commercialize Immunocore's tebentafusp (IMCgp100), for the treatment of patients with metastatic uveal melanoma, in Canada, twenty markets across Central Eastern Europe and Israel.

    "Following the acceptances of the Biologics License Application and Marketing Authorization Application for tebentafusp in metastatic uveal melanoma by regulatory agencies in the U.S. and Europe, we are excited to partner with Medison Pharma to increase our potential ability to reach patients with metastatic uveal melanoma in many more countries," said Ralph Torbay, Head of Commercial at Immunocore.

    "We are delighted to partner with Immunocore in 22 markets to accelerate the global reach of this breakthrough treatment for metastatic uveal melanoma", said Meir Jakobsohn, Founder and CEO of Medison Pharma. "In our joint commitment to help treat patients suffering from the most challenging diseases, we look forward to leveraging our commercial platform and providing patients in international markets with access to this much needed therapy."

    Tebentafusp has been granted Priority Review; Real Time Oncology Review; Breakthrough Therapy designation; Fast Track designation; and orphan drug designation by the U.S. Food and Drug Administration (FDA) in the United States; orphan drug status in the European Union; and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. Tebentafusp has also been granted accelerated assessment by the European Medicine Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP). Immunocore's biologics license application for approval of tebentafusp for the treatment of HLA-A*02:01-positive adult patients with metastatic uveal melanoma was recently accepted by the FDA. In addition, EMA's CHMP has accepted Immunocore's Marketing Authorisation Application.

    About Immunocore

    Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, infectious and autoimmune. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs. Immunocore's most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies.

    About Medison

    Medison is a global pharma company focused on providing access to highly innovative therapies to patients in international markets.

    Medison is the first to create an international commercialization platform for highly innovative therapies, helping to save and improve lives by making the best available novel treatments accessible to patients in international markets. Medison has a track record of multi-territorial partnerships with leading pharmaceutical and biotech companies seeking to expand their global reach.

    Medison is also an active investor in disruptive healthcare technologies and provides its partners with exposure to innovation in biotech and digital health. To learn more visit www.medisonpharma.com and follow us on LinkedIn.

    About Tebentafusp

    Tebentafusp is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. Tebentafusp specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma, and is the first molecule developed using Immunocore's ImmTAC technology platform designed to redirect and activate T cells to recognise and kill tumour cells. Tebentafusp has been granted Priority Review; Real Time Oncology Review; Breakthrough Therapy designation; Fast Track designation; and orphan drug designation by the FDA in the United States; orphan drug status in the European Union; and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. Tebentafusp has also been granted accelerated assessment by the EMA's CHMP. Tebentafusp is being reviewed under the FDA's Project Orbis initiative, which enables concurrent review by the health authorities in partner countries that have requested participation. For more information about enrolling in tebentafusp clinical trials for metastatic uveal melanoma, please visit ClinicalTrials.gov (NCT03070392).

    About ImmTAC® Molecules

    Immunocore's proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilising monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognise and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognise intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an anti-CD3 immune-activating effector function. Based on the demonstrated mechanism of T cell infiltration into human tumours, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumours, regardless of mutational burden or immune infiltration, including immune "cold" low mutation rate tumours.

    About Uveal Melanoma

    Uveal melanoma is a rare and aggressive form of melanoma, which affects the eye. Metastatic uveal melanoma typically has a poor prognosis and has no currently accepted optimal management or treatment. Although it is the most common primary intraocular malignancy in adults, the diagnosis is rare, with approximately 8,000 new patients diagnosed globally each year (1,600-2,000 cases per year in the United States). Up to 50% of people with uveal melanoma will eventually develop metastatic disease. When the cancer spreads beyond the eye, only approximately half of patients will survive for one year.

    Forward Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the efficacy, safety and therapeutic potential of tebentafusp; the clinical development of tebentafusp; the potential benefit of Breakthrough Therapy Designation, Fast Track Designation, Orphan Drug Designation, Priority Review or Accelerated Assessment for tebentafusp; the likelihood of obtaining regulatory approval of tebentafusp; the regulatory approval path and potential commercialization plans for tebentafusp including the timing of such approval decisions; and the expected benefits of tebentafusp including that tebentafusp would be a therapeutic option treatment for metastatic uveal melanoma. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, many of which are beyond the Company's control. These risks and uncertainties include, but are not limited to, the impacts of the COVID-19 pandemic on the Company's business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrolment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; and the uncertainties and timing of the regulatory approval process. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 25, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the Company's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information except as required by law.

    CONTACT: 

    Immunocore

    Debra Nielsen, Head of Communications

    T: +1 (610) 368-8602

    E: debra.nielsen@immunocore.com

    Follow on Twitter: @Immunocore

    Consilium Strategic Communications (corporate and financial)

    Mary-Jane Elliott/ Chris Welsh/ Jessica Hodgson

    T: +44 (0)203 709 5700

    E: Immunocore@consilium-comms.com

    Investor Relations  

    Clayton Robertson, Head of Investor Relations

    T: +1 215-384-4781

    E: ir@immunocore.com

    Medison

    Maya Nix, Corporate Communications Lead

    T: +972-3-925-0349

    E: mayan@medison.co.il



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  2. Press Release

    Immunocore announces publication of phase 3 data comparing tebentafusp with investigator's choice in The New England Journal of Medicine

    Tebentafusp demonstrated prolonged overall survival (OS) compared to investigator's choice therapy in previously untreated, metastatic uveal melanoma patients

    Tebentafusp is first T cell receptor (TCR) therapeutic to demonstrate a survival benefit

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 22 September 2021) Immunocore Holdings Plc (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease…

    Press Release

    Immunocore announces publication of phase 3 data comparing tebentafusp with investigator's choice in The New England Journal of Medicine

    Tebentafusp demonstrated prolonged overall survival (OS) compared to investigator's choice therapy in previously untreated, metastatic uveal melanoma patients

    Tebentafusp is first T cell receptor (TCR) therapeutic to demonstrate a survival benefit

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 22 September 2021) Immunocore Holdings Plc (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease, today announces that data from a phase 3 randomized trial comparing tebentafusp (IMCgp100) with investigator's choice in first-line metastatic uveal melanoma (mUM) has been published in The New England Journal of Medicine (NEJM).

    The paper concluded that tebentafusp is the first systemic treatment to show a survival benefit in mUM and should become a new treatment option for this poor prognosis disease.

            

    "The publication of these phase 3 data in a leading peer-reviewed scientific publication like NEJM demonstrates the significance of Immunocore's work in the field of TCR therapy," said Bahija Jallal, Chief Executive Officer of Immunocore. "This further validates the potential of tebentafusp to provide a much needed treatment option for patients with metastatic uveal melanoma, making a meaningful difference to patients' lives. In addition, we believe these data show the broader potential of Immunocore's TCR technology for the treatment of other solid tumors."

    Results from the randomized, open-label, phase 3 trial of tebentafusp vs. investigator's choice in previously untreated HLA-A*02:01-positive patients with mUM demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) as a first-line treatment in mUM. The OS Hazard Ratio (HR) in the intent-to-treat population favored tebentafusp, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator's choice (82% pembrolizumab; 12% ipilimumab; 6% dacarbazine). Treatment-related adverse events were manageable and consistent with the proposed mechanism.

    Tebentafusp has been granted Breakthrough Therapy Designation, Fast Track designation and orphan drug designation by the U.S. Food and Drug Administration (FDA) and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. Immunocore's biologics license application for approval of tebentafusp for the treatment of HLA-A*02:01-positive adult patients with metastatic uveal melanoma was recently accepted by the FDA. In addition, the European Medicine Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) accepted Immunocore's Marketing Authorisation Application (MAA).

    ##

    About Immunocore

    Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, infectious and autoimmune. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs. Immunocore's most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies.

    About Tebentafusp

    Tebentafusp is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. Tebentafusp specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma, and is the first molecule developed using Immunocore's ImmTAC technology platform designed to redirect and activate T cells to recognise and kill tumor cells. Tebentafusp has been granted Priority Review; Real Time Oncology Review; Breakthrough Therapy designation; Fast Track designation; and orphan drug designation by the FDA in the United States; orphan drug status in the European Union; and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. Tebentafusp has also been granted accelerated assessment by the EMA's Committee for Medicinal Products for Human Use (CHMP). Tebentafusp is being reviewed under the FDA's Project Orbis initiative, which enables concurrent review by the health authorities in partner countries that have requested participation. For more information about enrolling in tebentafusp clinical trials for metastatic uveal melanoma, please visit ClinicalTrials.gov (NCT03070392).

    About ImmTAC® Molecules

    Immmunocore's proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilising monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognise and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognise intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an anti-CD3 immune-activating effector function. Based on the demonstrated mechanism of T cell infiltration into human tumours, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumours, regardless of mutational burden or immune infiltration, including immune "cold" low mutation rate tumours.

    About Uveal Melanoma

    Uveal melanoma is a rare and aggressive form of melanoma, which affects the eye. Metastatic uveal melanoma typically has a poor prognosis and has no currently accepted optimal management or treatment. Although it is the most common primary intraocular malignancy in adults, the diagnosis is rare, with approximately 8,000 new patients diagnosed globally each year (1,600-2,000 cases per year in the United States). Up to 50% of people with uveal melanoma will eventually develop metastatic disease. When the cancer spreads beyond the eye, only approximately half of patients will survive for one year.

    Forward Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the efficacy, safety and therapeutic potential of tebentafusp, the design, progress, timing, scope and results of the Company's clinical trials including IMCgp100-202, the anticipated timing of disclosure of results of clinical trials, plans for initiating future clinical trials and extension studies, the progress of the Company's development programs including tebentafusp, the potential benefit of Breakthrough Therapy Designation, Fast Track designation, orphan drug designation or Promising Innovative Medicine designation for tebentafusp, the likelihood of obtaining regulatory approval of any of the Company's product candidates including tebentafusp, and the regulatory approval path for tebentafusp. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, many of which are beyond the Company's control. These risks and uncertainties include, but are not limited to, the impacts of the COVID-19 pandemic on the Company's business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; and the uncertainties and timing of the regulatory approval process. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 25, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the Company's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information except as required by law.

    CONTACT: 

    Immunocore

    Debra Nielsen, Head of Communications

    T: +1 (610) 368-8602

    E: debra.nielsen@immunocore.com

    Follow on Twitter: @Immunocore

    Consilium Strategic Communications (corporate and financial)

    Mary-Jane Elliott/ Chris Welsh/ Jessica Hodgson

    T: +44 (0)203 709 5700

    E: Immunocore@consilium-comms.com

    Investor Relations  

    Clayton Robertson, Head of Investor Relations

    T: +1 215-384-4781

    E: ir@immunocore.com



    Primary Logo

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  3. PRESS RELEASE

    Immunocore presents data at the European Society for Medical Oncology (ESMO) Congress 2021 demonstrating a reduction in circulating tumor DNA (ctDNA) while on tebentafusp is associated with overall survival in the Phase 2 clinical trial

    Linear correlation between the magnitude of ctDNA reduction on tebentafusp and improved overall survival

    70% of evaluable patients had any ctDNA reduction and 14% had ctDNA clearance

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US (20 September 2021) Immunocore Holdings Plc (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer…

    PRESS RELEASE

    Immunocore presents data at the European Society for Medical Oncology (ESMO) Congress 2021 demonstrating a reduction in circulating tumor DNA (ctDNA) while on tebentafusp is associated with overall survival in the Phase 2 clinical trial

    Linear correlation between the magnitude of ctDNA reduction on tebentafusp and improved overall survival

    70% of evaluable patients had any ctDNA reduction and 14% had ctDNA clearance

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US (20 September 2021) Immunocore Holdings Plc (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, presented new data from the Company's lead program, tebentafusp (IMCgp100), at an oral presentation at the European Society for Medical Oncology (ESMO) Congress.

    The findings presented by Alexander N. Shoushtari MD, medical oncologist at Memorial Sloan Kettering Cancer Center, demonstrated that reduction by Week 9 in circulating tumor DNA (ctDNA) while on tebentafusp is strongly associated with overall survival (OS). A majority (70%) of evaluable patients had any ctDNA reduction while 5% of patients had radiographic response per the RECISTv1.1 criteria. In addition, 14% of patients had complete ctDNA clearance and long OS; this included some patients with best response of stable or progressive disease. The analysis was based on the phase 2 trial of tebentafusp in HLA-A*02:01 positive, previously treated patients with metastatic uveal melanoma (mUM) (IMCgp100-102).

    "Uveal melanoma is characterized by a defined set of unique mutations that can be measured in the blood as free circulating tumor DNA," said David Berman, Immunocore's Head of Research and Development, "We found that the degree of ctDNA reduction from tebentafusp was strikingly correlated with overall survival. This association was observed even in patients whose tumor lesions appeared radiographically stable or progressing and suggests that clinical benefit from tebentafusp may occur even in patients who did not have a RECIST response."

    The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) have each accepted applications seeking the approval of tebentafusp for the treatment of HLA-A*02:01-positive adult patients with metastatic uveal melanoma based on the primary endpoint of overall survival (OS) from the Phase 3 study IMCgp100-202.

    About Immunocore

    Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, infectious and autoimmune. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs. Immunocore's most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies.

    About Tebentafusp

    Tebentafusp is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. Tebentafusp specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma, and is the first molecule developed using Immunocore's ImmTAC technology platform designed to redirect and activate T cells to recognise and kill tumour cells. Tebentafusp has been granted Priority Review; Real Time Oncology Review; Breakthrough Therapy designation; Fast Track designation; and orphan drug designation by the FDA in the United States; orphan drug status in the European Union; and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. Tebentafusp has also been granted accelerated assessment by the EMA's Committee for Medicinal Products for Human Use (CHMP). Tebentafusp is being reviewed under the FDA's Project Orbis initiative, which enables concurrent review by the health authorities in partner countries that have requested participation. For more information about enrolling in tebentafusp clinical trials for metastatic uveal melanoma, please visit ClinicalTrials.gov (NCT03070392).

    About ImmTAC® Molecules

    Immunocore's proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilising monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognise and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognise intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an anti-CD3 immune-activating effector function. Based on the demonstrated mechanism of T cell infiltration into human tumours, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumours, regardless of mutational burden or immune infiltration, including immune "cold" low mutation rate tumours.

    About Uveal Melanoma

    Uveal melanoma is a rare and aggressive form of melanoma, which affects the eye. Metastatic uveal melanoma typically has a poor prognosis and has no currently accepted optimal management or treatment. Although it is the most common primary intraocular malignancy in adults, the diagnosis is rare, with approximately 8,000 new patients diagnosed globally each year (1,600-2,000 cases per year in the United States). Up to 50% of people with uveal melanoma will eventually develop metastatic disease. When the cancer spreads beyond the eye, only approximately half of patients will survive for one year.

    Forward Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the efficacy, safety and therapeutic potential of tebentafusp; the clinical development of tebentafusp; the potential benefit of Breakthrough Therapy Designation, Fast Track Designation, Orphan Drug Designation, Priority Review or Accelerated Assessment for tebentafusp; the likelihood of obtaining regulatory approval of tebentafusp; the regulatory approval path and potential commercialization plans for tebentafusp including the timing of such approval decisions, including receipt of a CHMP opinion; and the expected benefits of tebentafusp including that tebentafusp would be a therapeutic option treatment for metastatic uveal melanoma. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, many of which are beyond the Company's control. These risks and uncertainties include, but are not limited to, the impacts of the COVID-19 pandemic on the Company's business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrolment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; and the uncertainties and timing of the regulatory approval process. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 25, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the Company's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information except as required by law.

    CONTACT: 

    Immunocore

    Debra Nielsen, Head of Communications

    T: +1 (610) 368-8602

    E: debra.nielsen@immunocore.com

    Follow on Twitter: @Immunocore

    Consilium Strategic Communications (corporate and financial)

    Mary-Jane Elliott/ Chris Welsh/ Jessica Hodgson

    T: +44 (0)203 709 5700

    E: Immunocore@consilium-comms.com

    Investor Relations  

    Clayton Robertson, Head of Investor Relations

    T: +1 215-384-4781

    E: ir@immunocore.com



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  4. PRESS RELEASE

    Immunocore Announces Upcoming Presentations at the European Society for Medical Oncology (ESMO) Congress 2021

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US 13 September 2021) Immunocore Holdings Plc (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, today announces that new data and analysis from the Company's lead program, tebentafusp, and its proprietary soluble TCR bispecific ImmTAC® platform will be presented at the European Society for Medical Oncology (ESMO) Congress, which will be held virtually from September…

    PRESS RELEASE

    Immunocore Announces Upcoming Presentations at the European Society for Medical Oncology (ESMO) Congress 2021

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US 13 September 2021) Immunocore Holdings Plc (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, today announces that new data and analysis from the Company's lead program, tebentafusp, and its proprietary soluble TCR bispecific ImmTAC® platform will be presented at the European Society for Medical Oncology (ESMO) Congress, which will be held virtually from September 16-21, 2021.

    ORAL PRESENTATION

    Title: Early reduction in ctDNA, regardless of best RECIST response, is associated with overall survival (OS) on tebentafusp in previously treated metastatic uveal melanoma (mUM) patients

    • Abstract ID: 17570
    • Presenter: Alexander Shoushtari
    • Abstract & full data set available: Friday, 17 September 2021, 18:00 CEST



    POSTER PRESENTATIONS

    Title: Similar overall survival in tebentafusp-treated 2L+ metastatic uveal melanoma regardless of prior immunotherapy  

    • Abstract ID: 1013P
    • Presenter: Joseph M. Piulats

    TitleDemonstration of T cell redirection and immune activation in skin rash following tebentafusp treatment

    • Abstract ID: 1772P
    • Presenter: Ramon Stäger

    Title: Characterization of cytokine release syndrome (CRS) following treatment with tebentafusp in previously untreated patients with metastatic uveal melanoma

    • Abstract ID: 1014P
    • Presenter: April Salama

    Title: Characterization of liver function tests following tebentafusp in phase 3 randomized trial comparing tebentafusp with investigator's choice in first line metastatic uveal melanoma (mUM)

    • Abstract ID: 1018P
    • Presenter: Bartosz Chmielowski

    Title: Genomic correlates of clinical outcomes in patients with metastatic uveal melanoma (mUM) treated with tebentafusp (tebe)

    • Abstract ID: 1770P
    • Presenter: Luis de la Cruz Merino

    Title: ImmTAC redirect exhausted tumor infiltrating T cells, an effect enhanced by pembrolizumab against PD-L1+ tumors

    • Poster #: 1016P
    • Presenter: Kristina Petrovic

    Title: PRAME expression and ImmTAC TCR bispecific sensitivity in acute myeloid leukaemia in the presence and absence of the hypomethylating agent decitabine

    • Abstract ID: 853P
    • Presenter: Camille Britton-Rivet

    The abstracts referenced above our available on the ESMO website.

    About Immunocore

    Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, infectious and autoimmune. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs. Immunocore's most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies.

    About Tebentafusp

    Tebentafusp is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. Tebentafusp specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma, and is the first molecule developed using Immunocore's ImmTAC technology platform designed to redirect and activate T cells to recognise and kill tumour cells. Tebentafusp has been granted Priority Review; Real Time Oncology Review; Breakthrough Therapy designation; Fast Track designation; and orphan drug designation by the FDA in the United States; orphan drug status in the European Union; and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. Tebentafusp has also been granted accelerated assessment by the EMA's Committee for Medicinal Products for Human Use (CHMP). Tebentafusp is being reviewed under the FDA's Project Orbis initiative, which enables concurrent review by the health authorities in partner countries that have requested participation. For more information about enrolling in tebentafusp clinical trials for metastatic uveal melanoma, please visit ClinicalTrials.gov (NCT03070392).

    About ImmTAC® Molecules

    Immunocore's proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilising monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognise and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognise intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an anti-CD3 immune-activating effector function. Based on the demonstrated mechanism of T cell infiltration into human tumours, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumours, regardless of mutational burden or immune infiltration, including immune "cold" low mutation rate tumours.

    Forward Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the efficacy, safety and therapeutic potential of tebentafusp; the clinical development of tebentafusp; the potential benefit of Breakthrough Therapy Designation, Fast Track Designation, Orphan Drug Designation, Priority Review or Accelerated Assessment for tebentafusp; the likelihood of obtaining regulatory approval of tebentafusp; the regulatory approval path and potential commercialization plans for tebentafusp including the timing of such approval decisions, including (i) the PDUFA target action date of February 23, 2022 and (ii) receipt of a CHMP opinion; the expected benefits of tebentafusp including that tebentafusp would be a therapeutic option treatment for metastatic uveal melanoma; and potential growth opportunities and trends in oncology. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, many of which are beyond the Company's control. These risks and uncertainties include, but are not limited to, the impacts of the COVID-19 pandemic on the Company's business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrolment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; and the uncertainties and timing of the regulatory approval process. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 25, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the Company's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information except as required by law.

    CONTACT: 

    Immunocore

    Debra Nielsen, Head of Communications

    T: +1 (610) 368-8602

    E: debra.nielsen@immunocore.com

    Follow on Twitter: @Immunocore

    Consilium Strategic Communications (corporate and financial)

    Mary-Jane Elliott/ Chris Welsh/ Jessica Hodgson

    T: +44 (0)203 709 5700

    E: Immunocore@consilium-comms.com

    Investor Relations  

    Clayton Robertson, Head of Investor Relations

    T: +1 215-384-4781

    E: ir@immunocore.com



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  5. PRESS RELEASE

    Immunocore to present at upcoming investor conferences

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 10 September 2021) Immunocore Holdings plc (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, today announced that management will present at the following investor conferences in September.

    • H.C. Wainwright 23rd Annual Global Investment Conference
      Fireside Chat available on demand starting at 7:00 a.m. ET on Monday, September 13, 2021
    • Oppenheimer Fall Healthcare Life Sciences & MedTech Summit
      Fireside Chat…

    PRESS RELEASE

    Immunocore to present at upcoming investor conferences

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 10 September 2021) Immunocore Holdings plc (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, today announced that management will present at the following investor conferences in September.

    • H.C. Wainwright 23rd Annual Global Investment Conference

      Fireside Chat available on demand starting at 7:00 a.m. ET on Monday, September 13, 2021

    • Oppenheimer Fall Healthcare Life Sciences & MedTech Summit

      Fireside Chat: Wednesday, September 22, 2021 at 2:05 p.m. ET

    The investor conferences will each be held in a virtual format and a live webcast of each presentation can be accessed in the ‘Investors' section of Immunocore's website at www.immunocore.com. For conferences that offer replays, presentations will be made available for a limited time.

    About Immunocore

    Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilising monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, infectious and autoimmune. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs. Immunocore's most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies.

    Forward Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but are not limited to, statements regarding the Company's business strategy including its proposed regulatory plans for tebentafusp, the efficacy, safety and therapeutic potential of tebentafusp, the planned timing of a complete BLA submission for tebentafusp for the treatment of mUM in the third quarter of 2021, the potential approval and commercial launch of tebentafusp for mUM, the design, progress, timing, scope and results of the Company's clinical trials including IMC-C103C, IMC-F106C and IMC-I109V, the anticipated achievement of upcoming clinical milestones, the potential benefit of Breakthrough Therapy Designation or Orphan Drug Designation for tebentafusp, and the Company's anticipated cash runway. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, many of which are beyond the Company's control. These risks and uncertainties include, but are not limited to, the impacts of the COVID-19 pandemic on the Company's business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; the risk that initial or interim results from a clinical trial may not be predictive of the final results of the trial or the results of future trials; changes in expected or existing competition; changes in the regulatory environment; and the uncertainties and timing of the regulatory approval process. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in the Company's Annual Report on Form 20-F for the year ended December 31, 2020 filed with the Securities and Exchange Commission on March 25, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the Company's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information, except as required by law.

    CONTACT: 

    Immunocore

    Debra Nielsen, Head of Communications

    T: +1 (610) 368-8602

    E: debra.nielsen@immunocore.com

    Follow on Twitter: @Immunocore

    Consilium Strategic Communications (corporate and financial)

    Mary-Jane Elliott/ Chris Welsh/ Jessica Hodgson

    T: +44 (0)203 709 5700

    E: Immunocore@consilium-comms.com

    Investor Relations  

    Clayton Robertson, Head of Investor Relations

    T: +1 215-384-4781

    E: ir@immunocore.com



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  6. PRESS RELEASE

    Immunocore Announces UK's Medicines and Healthcare Products Regulatory Agency (MHRA) Accepts Marketing Authorization Application for Tebentafusp in Metastatic Uveal Melanoma

    MHRA's acceptance follows acceptances by the U.S. Food and Drug Administration and European Medicines Agency of Biologics License Application and Marketing Authorisation Application respectively for Tebentafusp in Metastatic Uveal Melanoma

    Tebentafusp application part of the FDA's Project Orbis initiative in the UK

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 8 September 2021) Immunocore (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies…

    PRESS RELEASE

    Immunocore Announces UK's Medicines and Healthcare Products Regulatory Agency (MHRA) Accepts Marketing Authorization Application for Tebentafusp in Metastatic Uveal Melanoma

    MHRA's acceptance follows acceptances by the U.S. Food and Drug Administration and European Medicines Agency of Biologics License Application and Marketing Authorisation Application respectively for Tebentafusp in Metastatic Uveal Melanoma

    Tebentafusp application part of the FDA's Project Orbis initiative in the UK

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 8 September 2021) Immunocore (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, today announces that United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) has accepted a Market Authorisation Application (MAA) seeking the approval of tebentafusp (IMCgp100) for the treatment of patients with metastatic uveal melanoma (mUM).

    Tebentafusp is also being reviewed in the UK under the U.S. Food and Drug Administration's (FDA) Project Orbis initiative, which enables concurrent review by the health authorities in participating partner countries. As previously announced, the FDA and European Medicines Agency have accepted the Biologics License Application (BLA) and MAA respectively for tebentafusp. In the United States, the BLA was initiated and will be reviewed under the Real-Time Oncology Review (RTOR) pilot program.

    The regulatory submissions for tebentafusp are based on data from the randomized Phase 3 IMCgp100-202 clinical trial evaluating tebentafusp in previously untreated metastatic uveal melanoma, a cancer that has historically proven to be frequently insensitive to other immunotherapies. In the final study analysis, tebentafusp demonstrated clinically and statistically significant superior overall survival (OS) benefit as a monotherapy. The primary endpoint was achieved with the OS Hazard Ratio (HR) in the intent-to-treat population favoring tebentafusp, HR=0.51 [95% CI (0.37, 0.71); p< 0.0001] over investigator's choice (82% pembrolizumab; 12% ipilimumab; 6% dacarbazine).

    Bahija Jallal, Chief Executive Officer of Immunocore, said: "We are delighted that the MHRA has accepted our application for tebentafusp and the FDA has selected tebentafusp for the Project Orbis initiative. As a UK-founded biotech company pioneering the field of TCR therapeutics, we are encouraged with these regulatory milestones that brings us closer to helping people with metastatic uveal melanoma in the UK and abroad. The regulatory agencies recognise the urgent need for an approved treatment specific to mUM, an aggressive form of cancer for which the recommended option for patients is enrolment into a clinical trial."

    About Immunocore

    Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, infectious and autoimmune. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs. Immunocore's most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies.

    About Tebentafusp

    Tebentafusp is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. Tebentafusp specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma, and is the first molecule developed using Immunocore's ImmTAC technology platform designed to redirect and activate T cells to recognise and kill tumour cells. Tebentafusp has been granted Priority Review; Real Time Oncology Review; Breakthrough Therapy designation; Fast Track designation; and orphan drug designation by the FDA in the United States; orphan drug status in the European Union; and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. Tebentafusp has also been granted accelerated assessment by the EMA's Committee for Medicinal Products for Human Use (CHMP). Tebentafusp is being reviewed under the FDA's Project Orbis initiative, which enables concurrent review by the health authorities in partner countries that have requested participation. For more information about enrolling in tebentafusp clinical trials for metastatic uveal melanoma, please visit ClinicalTrials.gov (NCT03070392).

    About ImmTAC® Molecules

    Immunocore's proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilising monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognise and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognise intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an anti-CD3 immune-activating effector function. Based on the demonstrated mechanism of T cell infiltration into human tumours, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumours, regardless of mutational burden or immune infiltration, including immune "cold" low mutation rate tumours.

    About Uveal Melanoma

    Uveal melanoma is a rare and aggressive form of melanoma, which affects the eye. Metastatic uveal melanoma typically has a poor prognosis and has no currently accepted optimal management or treatment. Although it is the most common primary intraocular malignancy in adults, the diagnosis is rare, with approximately 8,000 new patients diagnosed globally each year (1,600-2,000 cases per year in the United States). Up to 50% of people with uveal melanoma will eventually develop metastatic disease. When the cancer spreads beyond the eye, only approximately half of patients will survive for one year.

    Forward Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the efficacy, safety and therapeutic potential of tebentafusp; the clinical development of tebentafusp; the potential benefit of Breakthrough Therapy Designation, Fast Track Designation, Orphan Drug Designation, Priority Review or Accelerated Assessment for tebentafusp; the likelihood of obtaining regulatory approval of tebentafusp; the regulatory approval path and potential commercialization plans for tebentafusp including the timing of such approval decisions, including (i) the PDUFA target action date of February 23, 2022 and (ii) receipt of a CHMP opinion; the expected benefits of tebentafusp including that tebentafusp would be a therapeutic option treatment for metastatic uveal melanoma; and potential growth opportunities and trends in oncology. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, many of which are beyond the Company's control. These risks and uncertainties include, but are not limited to, the impacts of the COVID-19 pandemic on the Company's business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrolment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; and the uncertainties and timing of the regulatory approval process. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 25, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the Company's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information except as required by law.

    CONTACT: 

    Immunocore

    Debra Nielsen, Head of Communications

    T: +1 (610) 368-8602

    E: debra.nielsen@immunocore.com

    Follow on Twitter: @Immunocore

    Consilium Strategic Communications (corporate and financial)

    Mary-Jane Elliott/ Chris Welsh/ Jessica Hodgson

    T: +44 (0)203 709 5700

    E: Immunocore@consilium-comms.com

    Investor Relations  

    Clayton Robertson, Head of Investor Relations

    T: +1 215-384-4781

    E: ir@immunocore.com



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  7. PRESS RELEASE

    Immunocore Announces that U.S. Food and Drug Administration and European Medicines Agency accept Biologics License Application and Marketing Authorization Application for Tebentafusp in Metastatic Uveal Melanoma

    FDA grants Priority Review to tebentafusp for the treatment of HLA-A*02:01-positive patients with metastatic uveal melanoma; with an expected Prescription Drug User Fee Act (PDUFA) target action date of February 23, 2022

    EMA Committee for Medicinal Products for Human Use accepted tebentafusp Marketing Authorization Application and will review under Accelerated Assessment Procedure

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, August 24, 2021) Immunocore Holdings Plc (NASDAQ:IMCR), a late-stage biotechnology…

    PRESS RELEASE

    Immunocore Announces that U.S. Food and Drug Administration and European Medicines Agency accept Biologics License Application and Marketing Authorization Application for Tebentafusp in Metastatic Uveal Melanoma

    FDA grants Priority Review to tebentafusp for the treatment of HLA-A*02:01-positive patients with metastatic uveal melanoma; with an expected Prescription Drug User Fee Act (PDUFA) target action date of February 23, 2022

    EMA Committee for Medicinal Products for Human Use accepted tebentafusp Marketing Authorization Application and will review under Accelerated Assessment Procedure

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, August 24, 2021) Immunocore Holdings Plc (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, today announces that regulators in the United States and European Union have each accepted applications for the approval of tebentafusp (IMCgp100) for the treatment of HLA-A*02:01-positive adult patients with metastatic uveal melanoma (mUM).

    The U.S. Food and Drug Administration (FDA) has accepted for review Immunocore's Biologics License application (BLA) for tebentafusp (IMCgp100). The FDA has granted Priority Review to the Company's BLA submission, a designation for drugs which, if approved, may provide significant improvements in the safety and effectiveness of the treatment of serious conditions. Priority Review designation shortens the review period from the standard ten months to six months from the filing acceptance of the BLA, and therefore, an expected PDUFA target action date of February 23, 2022.

    The BLA was initiated and will be reviewed under the Real-Time Oncology Review (RTOR) pilot program, an initiative of the FDA's Oncology Center of Excellence which is designed to expedite the delivery of safe and effective cancer treatments to patients. Tebentafusp is also being reviewed under the FDA's Project Orbis initiative, which enables concurrent review by the health authorities in partner countries that have requested participation. Previously, the FDA has granted Breakthrough Therapy Designation (BTD) to tebentafusp for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

    The European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP), accepted Immunocore's Marketing Authorization Application (MAA). The EMA has also agreed to the Company's request for accelerated assessment of its MAA based on the determination that tebentafusp is a product of major interest for public health and therapeutic innovation. Accelerated assessment potentially reduces the time frame for the CHMP and Committee for Advanced Therapies (CAT) to review the Company's submitted MAA for advanced therapies. While the CHMP review period of a MAA can take up to 210 days, the accelerated assessment reduces the timeframe for review of the MAA to 150 days (excluding clock-stops).

    The regulatory submissions are based on data from the randomized Phase 3 IMCgp100-202 clinical trial evaluating tebentafusp in previously untreated metastatic uveal melanoma, a cancer that has historically proven to be frequently insensitive to other immunotherapies. In the final trial analysis, tebentafusp demonstrated clinically and statistically significant superior overall survival (OS) benefit as a monotherapy. The primary endpoint was achieved with the OS Hazard Ratio (HR) in the intent-to-treat population favoring tebentafusp, HR=0.51 [95% CI (0.37, 0.71); p< 0.0001] over investigator's choice (82% pembrolizumab; 12% ipilimumab; 6% dacarbazine).

    Bahija Jallal, Chief Executive Officer of Immunocore, said: "There is an urgent need for an approved treatment for metastatic uveal melanoma, an aggressive form of cancer for which there are very limited treatment options. We are excited to work with the FDA and EMA to bring tebentafusp to patients as quickly as possible."

    About Immunocore

    Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, infectious and autoimmune. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs. Immunocore's most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies.

    About Tebentafusp

    Tebentafusp is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. Tebentafusp specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma, and is the first molecule developed using Immunocore's ImmTAC technology platform designed to redirect and activate T cells to recognise and kill tumour cells. Tebentafusp has been granted Priority Review; Real Time Oncology Review; Breakthrough Therapy designation; Fast Track designation; and orphan drug designation by the FDA in the United States; orphan drug status in the European Union; and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. Tebentafusp has also been granted accelerated assessment by the EMA's Committee for Medicinal Products for Human Use (CHMP). Tebentafusp is being reviewed under the FDA's Project Orbis initiative, which enables concurrent review by the health authorities in partner countries that have requested participation. For more information about enrolling in tebentafusp clinical trials for metastatic uveal melanoma, please visit ClinicalTrials.gov (NCT03070392).

    About ImmTAC® Molecules

    Immunocore's proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilising monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognise and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognise intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an anti-CD3 immune-activating effector function. Based on the demonstrated mechanism of T cell infiltration into human tumours, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumours, regardless of mutational burden or immune infiltration, including immune "cold" low mutation rate tumours.

    About Uveal Melanoma

    Uveal melanoma is a rare and aggressive form of melanoma, which affects the eye. Metastatic uveal melanoma typically has a poor prognosis and has no currently accepted optimal management or treatment. Although it is the most common primary intraocular malignancy in adults, the diagnosis is rare, with approximately 8,000 new patients diagnosed globally each year (1,600-2,000 cases per year in the United States). Up to 50% of people with uveal melanoma will eventually develop metastatic disease. When the cancer spreads beyond the eye, only approximately half of patients will survive for one year.

    Forward Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the efficacy, safety and therapeutic potential of tebentafusp; the clinical development of tebentafusp; the potential benefit of Breakthrough Therapy Designation, Fast Track Designation, Orphan Drug Designation, Priority Review or Accelerated Assessment for tebentafusp; the likelihood of obtaining regulatory approval of tebentafusp; the regulatory approval path and potential commercialization plans for tebentafusp including the timing of such approval decisions, including (i) the PDUFA target action date of February 23, 2022 and (ii) receipt of a CHMP opinion; the expected benefits of tebentafusp including that tebentafusp would be a therapeutic option treatment for metastatic uveal melanoma; and potential growth opportunities and trends in oncology. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, many of which are beyond the Company's control. These risks and uncertainties include, but are not limited to, the impacts of the COVID-19 pandemic on the Company's business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrolment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; and the uncertainties and timing of the regulatory approval process. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 25, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the Company's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information except as required by law.

    CONTACT: 

    Immunocore

    Debra Nielsen, Head of Communications

    T: +1 (610) 368-8602

    E: debra.nielsen@immunocore.com

    Follow on Twitter: @Immunocore

    Consilium Strategic Communications (corporate and financial)

    Mary-Jane Elliott/ Chris Welsh/ Jessica Hodgson

    T: +44 (0)203 709 5700

    E: Immunocore@consilium-comms.com

    Investor Relations  

    Clayton Robertson, Head of Investor Relations

    T: +1 215-384-4781

    E: ir@immunocore.com



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  8. PRESS RELEASE

    Immunocore Reports Second Quarter 2021 Financial Results and Provides Business Update

    Biologics License Application (BLA) submission for tebentafusp in metastatic uveal melanoma remains on track for completion in Q3; FDA has granted tebentafusp Real Time Oncology Review (RTOR) and the application will be part of the Project Orbis initiative

    Submission of a Market Authorization Application (MAA) to the European Medicines Agency (EMA), and the United Kingdom's Medicines and Healthcare Regulatory Agency (MHRA) accelerated to Q3; EMA granted tebentafusp accelerated assessment procedure for this MAA
            
    Dose escalation of IMC-C103C targeting MAGE-A4 and IMC-F106C targeting PRAME continues as planned; initial Phase 1 MAGE-A4

    PRESS RELEASE

    Immunocore Reports Second Quarter 2021 Financial Results and Provides Business Update

    Biologics License Application (BLA) submission for tebentafusp in metastatic uveal melanoma remains on track for completion in Q3; FDA has granted tebentafusp Real Time Oncology Review (RTOR) and the application will be part of the Project Orbis initiative

    Submission of a Market Authorization Application (MAA) to the European Medicines Agency (EMA), and the United Kingdom's Medicines and Healthcare Regulatory Agency (MHRA) accelerated to Q3; EMA granted tebentafusp accelerated assessment procedure for this MAA

            

    Dose escalation of IMC-C103C targeting MAGE-A4 and IMC-F106C targeting PRAME continues as planned; initial Phase 1 MAGE-A4 data planned for Q4

    Cash position of approximately $385 million as of June 30, 2021

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 11 August 2021) Immunocore Holdings plc (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, today announced its financial results for the quarter and six months ended June 30, 2021 and provides a portfolio update.

    Immunocore's recent and second quarter highlights include the acceleration of tebentafusp regulatory submissions in the EU and UK; continued dose escalation of MAGE-A4 and PRAME targeting ImmTACs®; and the initiation of a single ascending dose trial for its ImmTAV® bispecific molecule for chronic hepatitis B (HBV).

    Bahija Jallal, Chief Executive Officer of Immunocore, said: "The team at Immunocore is focused on bringing our pioneering science to patients as quickly as possible.  We remain on track to complete the tebentafusp BLA submission in the US in the third quarter and are pleased to have accelerated our submissions in Europe, while also initiating our global early access program to make tebentafusp available to patients who need it now."

    "With the positive phase 3 results for tebentafusp in metastatic uveal melanoma, we now have demonstrated the first ever overall survival benefit for any TCR therapeutic," said David Berman, Head of Research and Development. "Our Phase 1 programs targeting MAGE-A4 and PRAME continue to dose escalate, with both now at biologically active doses. The start of our first clinical trial in chronic hepatitis B further highlights our confidence in the potential of our ImmTAX platform across a broad range of indications including cancer and infectious disease."

    Second Quarter 2021 Highlights (including post-period)

    Tebentafusp

    In July, the European Medicines Agency (EMA) granted tebentafusp accelerated assessment procedure for this Marketing Authorization Application (MAA). Accelerated assessment potentially reduces the time frame for the EMA Committee for Medicinal Products for Human Use (CHMP) and Committee for Advanced Therapies (CAT) to review a MAA for an Advanced Therapy Medicinal Product (ATMP). The U.S. Food and Drug Administration (FDA) will review the Biologics License application (BLA) for tebentafusp (IMCgp100) under the Real-Time Oncology Review (RTOR) pilot program, an initiative of the FDA's Oncology Center of Excellence designed to expedite the delivery of safe and effective cancer treatments to patients. Tebentafusp is also being reviewed under the FDA's Project Orbis initiative, which enables concurrent review by the health authorities in partner countries that have requested participation. Previously, the FDA has granted Breakthrough Therapy Designation (BTD) to tebentafusp (IMCgp100) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM).

    In June, the Company presented a subset analysis from the Phase 3 study exploring the overall survival benefit from tebentafusp in patients with best RECIST* response of progressive disease (PD) at the American Society of Clinical Oncology (ASCO) Annual Meeting. In patients with a best response of PD in the Phase 3 trial, the overall survival (OS) was superior for the tebentafusp arm versus the investigator's choice arm with a hazard ratio (HR) of 0.43 (95% CI 0.27-0.68). More than half of tebentafusp patients with best response PD were treated beyond initial progression and no new safety signals were observed. In addition, analysis from the Phase 2 tebentafusp trial suggests that at least one-third of patients on tebentafusp with a best response of PD have a reduction in circulating tumor DNA and that this may be associated with longer OS.

    In April, the Company launched a global early access program for tebentafusp in mUM.

    In April, the Company's Phase 3 data of tebentafusp in mUM was also the subject of an oral presentation in the Phase 3 clinical trials plenary session at the AACR Virtual Annual Meeting 2021. Tebentafusp demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) as a first-line treatment in mUM. In the intent-to-treat population, tebentafusp demonstrated a median overall survival of 21.7 months compared to 16.0 months for investigator's choice and with 73% of patients alive at 1 year for tebentafusp vs. 58% for investigator's choice. The OS Hazard Ratio (HR) favored tebentafusp, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator's choice (82% pembrolizumab; 12% ipilimumab; 6% dacarbazine). In addition, tebentafusp resulted in a statistically significant longer PFS. Treatment-related adverse events were manageable and consistent with the proposed mechanism.   

    The Company remains on track to complete submission of a BLA to the FDA in the third quarter of 2021. Additionally, the Company has accelerated the submission of a MAA to the EMA, and the United Kingdom's Medicines and Healthcare Regulatory Agency, or MHRA, to the third quarter of 2021.

    Additional Clinical Programs

    IMC-C103C targeting MAGE-A4

    In the second quarter, the Company continued to dose escalate IMC-C103C, an ImmTAC molecule targeting an HLA-A*02:01 MAGE-A4 antigen, in a first-in-human, Phase 1/2 dose escalation trial in patients with solid tumor cancers including non-small-cell lung cancer (NSCLC), gastric, head and neck, ovarian and synovial sarcoma. As of June 30, 2021, the Company has enrolled 39 patients in the Phase 1 study. Early pharmacodynamic data indicate that IMC-C103C monotherapy is demonstrating biological activity at the doses currently under evaluation. The Company plans to report this initial Phase 1 data in the fourth quarter of 2021.

    IMC-F106C targeting PRAME

    In the second quarter, the Company continued to dose escalate IMC-F106C, an ImmTAC molecule targeting an HLA-A*02:01 PRAME antigen, in a first-in-human, Phase 1/2 dose escalation trial in patients with multiple solid tumor cancers. PRAME is overexpressed in many solid tumors including NSCLC, SCLC, endometrial, ovarian, melanoma and breast cancers. As of June 30, 2021, the company has enrolled 23 patients in the Phase 1 study. Early pharmacodynamic data indicate that IMC-F106C monotherapy is demonstrating biological activity at the doses currently under evaluation. The Company plans to report this initial Phase 1 data in mid-2022.

    IMC-I109V targeting HBV

    In the second quarter, the Company initiated dosing in the IMC-I109V global Phase 1 single ascending dose trial. IMC-I109V is the first candidate in development using Immunocore's immune‐mobilising monoclonal T cell receptors against virus (ImmTAV®) platform to enter clinical trials. IMC-I109V targets a conserved Hepatitis B virus (HBV) envelope antigen and is being developed as a potential functional cure.

    Financial Results

    Basic and diluted loss per share was £0.75 or $1.04 for the three months ended June 30, 2021 as compared to an adjusted £0.63 for the three months ended June 30, 2020. Basic and diluted loss per share was £1.51 or $2.08 for the six months ended June 30, 2021 compared to an adjusted £1.39 for the six months ended June 30, 2020. Total operating loss for the three months ended June 30, 2021 was £34.5 million or $47.6 million compared to £20.5 million for the same period last year, largely due to an increase in employee costs associated with non-cash share-based payment charge. Total operating loss for the six months ended June 30, 2021 was £66.4 million or $91.6 million compared to £42.6 million for the same period last year, largely due to an increase in employee costs associated with non-cash share-based payment charge.

    For the three and six months ended June 30, 2021, revenue from collaboration agreements was £5.7 million or $7.9 million and £14.0 million or $19.3 million, respectively, as compared to £7.8 million and £16.0 million, respectively, for the three and six months ended June 30, 2020. For the three and six months ended June 30, 2021, research and development expenses were £16.5 million or $22.7 million and £36.4 million or $50.2 million, respectively, as compared to £16.4 million and £37.2 million, respectively, for the three and six months ended June 30, 2020. For the three and six months ended June 30, 2021, administrative expenses were £23.8 million or $32.9 million and £44.0 million or $60.7 million, respectively, compared to £12.3 million and £21.9 million respectively, for the three and six months ended June 30, 2020 including a £5.1 million and £13.0 million increase, respectively, in the non-cash share-based payment charge.

    Cash and cash equivalents are £278.9 million or approximately $385 million as of June 30, 2021 compared to £129.7 million as of December 31, 2020.

    ##

    About Tebentafusp

    Tebentafusp is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. Tebentafusp specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma, and is the first molecule developed using Immunocore's ImmTAC technology platform designed to redirect and activate T cells to recognise and kill tumour cells. Tebentafusp has been granted Breakthrough Therapy Designation, Fast Track designation and orphan drug designation by the FDA in the United States and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. The European Medicine Agency (EMA) has granted the Tebentafusp Marketing Authorization Application (MAA) for an Accelerated Assessment procedure based on the Committee for Medicinal Products for Human Use (CHMP) agreement that tebentafusp is a product of major interest for public health and therapeutic innovation. Tebentafusp is also being reviewed under the FDA's Project Orbis initiative, which enables concurrent review by the health authorities in partner countries that have requested participation. For more information about enrolling tebentafusp clinical trials for metastatic uveal melanoma, please visit ClinicalTrials.gov (NCT03070392).

    About Immunocore

    Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilising monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, infectious and autoimmune. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs. Immunocore's most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies.

    Forward Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but are not limited to, statements regarding the Company's business strategy including its proposed regulatory plans for tebentafusp, the efficacy, safety and therapeutic potential of tebentafusp, the planned timing of a complete BLA submission for tebentafusp for the treatment of mUM in the third quarter of 2021, the potential approval and commercial launch of tebentafusp for mUM, the design, progress, timing, scope and results of the Company's clinical trials including IMC-C103C, IMC-F106C and IMC-I109V, the anticipated achievement of upcoming clinical milestones, the potential benefit of Breakthrough Therapy Designation or Orphan Drug Designation for tebentafusp, and the Company's anticipated cash runway. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, many of which are beyond the Company's control. These risks and uncertainties include, but are not limited to, the impacts of the COVID-19 pandemic on the Company's business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; the risk that initial or interim results from a clinical trial may not be predictive of the final results of the trial or the results of future trials; changes in expected or existing competition; changes in the regulatory environment; and the uncertainties and timing of the regulatory approval process. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in the Company's Annual Report on Form 20-F for the year ended December 31, 2020 filed with the Securities and Exchange Commission on March 25, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the Company's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information, except as required by law.

    CONTACT: 

    Immunocore

    Debra Nielsen, Head of Communications

    T: +1 (610) 368-8602

    E: debra.nielsen@immunocore.com

    Follow on Twitter: @Immunocore

    Consilium Strategic Communications (corporate and financial)

    Mary-Jane Elliott/ Chris Welsh/ Jessica Hodgson

    T: +44 (0)203 709 5700

    E: Immunocore@consilium-comms.com

    Investor Relations  

    Clayton Robertson, Head of Investor Relations

    T: +1 215-384-4781

    E: ir@immunocore.com

    Consolidated Statement of Loss

    Comparison of the Three Months Ended June 30, 2021 and 2020:

     Three Months Ended June 30,
     20212020
     $000£000£000
    Revenue7,915  5,733  7,787
    Research and development expenses (22,740)  (16,471)  (16,378)
    Administrative expenses (32,860)  (23,801)  (12,250)
    Net other operating income 55  40  346
    Operating loss (47,630)  (34,499)  (20,495)
    Finance income 17  12  222
    Finance costs (1,778)  (1,288)  (635)
    Non-operating expense (1,761)  (1,276)  (413)
    Loss before taxes (49,391)  (35,775)  (20,908)
    Income tax credit 3,884  2,813  3,691
    Loss for the period (45,507)  (32,962)  (17,217)
    Basic and diluted loss per share$(1.04)  (0.75)  (0.63)

    Comparison of the Six Months Ended June 30, 2021 and 2020:

     Six Months Ended June 30,  
     20212020  
     $000£000£000  
    Revenue19,333  14,003  16,042  
    Research and development expenses (50,193)  (36,356)  (37,157) 
    Administrative expenses (60,726)  (43,985)  (21,855) 
    Net other operating (expense) / income (58)  (42)  356 
    Operating loss (91,644)  (66,380)  (42,614) 
    Finance income 47  34  1,605
    Finance costs (4,346)  (3,148)  (1,702) 
    Non-operating expense (4,299)  (3,114)  (97)
    Loss before taxes (95,943)  (69,494)  (42,711) 
    Income tax credit 10,346  7,494  6,855
    Loss for the period (85,597)  (62,000)  (35,856) 
    Basic and diluted loss per share$(2.08)  (1.51)  (1.39) 

    Condensed Consolidated Statement of Cash Flows for Each Period Presented:

     Six Months Ended June 30,
     202120212020
     $000£000£000
       (unaudited) 
    Cash and cash equivalents at beginning of year 179,085  129,716  73,966
    Net cash flows used in operating activities(80,867)  (58,575)  (40,645)
    Net cash flows from / (used in) investing activities61  44  (1,684)
    Net cash flows from financing activities286,834  207,761  25,054
    Net foreign exchange difference on cash held(105)  (76)  118
    Cash and cash equivalents at end of period385,008  278,870  56,809

    Consolidated Statements of Financial Position for Each Period Presented:

     June 30,



    2021



    £'000
    December 31,



    2020



    £'000
    Non-current assets  
    Property, plant and equipment10,98813,754
    Right of use assets    22,391  23,093
    Investment in sub-lease470776
    Other non-current financial assets5,4764,410 
    Deferred tax asset2,1922,230 
    Total non-current assets41,51744,263 
    Current assets   
    Trade and other receivables 12,19810,280
    Tax receivable 20,42812,935
    Cash and cash equivalents 278,870129,716 
    Total current assets 311,496152,931 
    Total assets 353,013197,194 
    Equity   
    Share capital 8864
    Share premium 211,286​--
    Foreign currency translation reserve 33163
    Other reserves    386,167  386,167
    Share-based payment reserve 36,43418,821 
    Accumulated deficit (411,869)​)(349,869) 
    Total equity 222,13955,346 
    Non-current liabilities   
    Interest-bearing loans and borrowings    36,135  36,654
    Deferred liabilities14,95324,868 
    Lease liabilities24,92325,190 
    Provisions175138 
    Total non-current liabilities 76,18686,850 
    Current liabilities  
    Interest-bearing loans and borrowings546---
    Trade and other payables27,02725,728
    Deferred liabilities25,39527,118
    Lease liabilities1,6052,043
    Provisions115109 
    Total current liabilities54,68854,998 
    Total liabilities130,874141,848 
    Total equity and liabilities353,013197,194 



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  9. PRESS RELEASE

    Immunocore presents clinical data further characterizing the overall survival benefit of tebentafusp in metastatic uveal melanoma at the
    2021 American Society of Clinical Oncology (ASCO) Annual Meeting

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 04 June 2021) Immunocore (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease, announces the presentation of a subset analysis from the Phase 3 study exploring the overall survival benefit from tebentafusp in patients with best RECIST* response of progressive disease at the…

    PRESS RELEASE

    Immunocore presents clinical data further characterizing the overall survival benefit of tebentafusp in metastatic uveal melanoma at the

    2021 American Society of Clinical Oncology (ASCO) Annual Meeting

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 04 June 2021) Immunocore (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease, announces the presentation of a subset analysis from the Phase 3 study exploring the overall survival benefit from tebentafusp in patients with best RECIST* response of progressive disease at the American Society of Clinical Oncology (ASCO) Annual Meeting being held virtually from June 4-8, 2021.

    "As a pioneer in the T cell receptor therapy class, we will continue to analyze the science and clinical data behind the survival benefit from tebentafusp which will also help advance the field of TCR bispecifics," said David Berman, Head of Research and Development at Immunocore. "At ASCO this year, we presented further analysis of the Phase 3 tebentafusp trial including an overall survival benefit from tebentafusp in patients with best response of progressive disease."

    In patients with a best response of progressive disease (PD) in the phase 3 trial, the overall survival (OS) was superior for the tebentafusp arm versus the investigator's choice arm with a hazard ratio (HR) of 0.43 (95%CI 0.27-0.68). More than half of tebentafusp patients with best response PD were treated beyond initial progression and no new safety signals were observed. In addition, analysis from the phase 2 tebentafusp trial suggests that at least one-third of patients on tebentafusp with a best response of PD have a reduction in circulating tumor DNA and that this may be associated with longer OS.

    Tebentafusp has been granted Breakthrough Therapy Designation, Fast Track Designation and Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. Immunocore will be working with the FDA to complete submission of a BLA for tebentafusp in the third quarter of 2021.

    _______________________________________

    *Response Evaluation Criteria in Solid Tumors

    CLINICAL SCIENCE SYMPOSIUM

    Title: Overall survival benefit from tebentafusp in patients with best response of progressive disease

    Presenter: Anthony Joshua, MD

    Date and Time: June 4, 2021; 9:00 a.m. EDT

    Session: Management of Rare Melanoma Subtypes

    Abstract ID: 9509

    POSTER PRESENTATIONS

    Title: Co-primary endpoint of overall survival for tebentafusp (tebe)-induced rash in a Phase 3 randomized trial comparing tebe vs. investigator's choice (IC) in first line metastatic uveal melanoma

    Session: Melanoma/Skin Cancers

    Abstract ID: 9527

    Title: Overall survival in patients who received checkpoint inhibitors after completing tebentafusp in a phase 3 randomized trial of first line metastatic uveal melanoma

    Session: Melanoma/Skin Cancers

    Abstract ID: 9526

    Title: Characterization of cytokine release syndrome (CRS) following treatment with tebentafusp in patients (pts) with previously treated (2L+) metastatic uveal melanoma (mUM).

    Session: Melanoma/Skin Cancers

    Abstract ID: 9531

    Due to the virtual format, all oral, poster, and poster discussion sessions, as well as track-based Clinical Science Symposia, will be available on demand, beginning June 4, 2021 at 9 a.m. EDT, for registered attendees of the conference.

    ##

    About Immunocore

    Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, infectious and autoimmune. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs. Immunocore's most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies.

    About ImmTAC® Molecules

    Immunocore's proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilising monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognise and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognise intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an anti-CD3 immune-activating effector function. Based on the demonstrated mechanism of T cell infiltration into human tumours, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumours, regardless of mutational burden or immune infiltration, including immune "cold" low mutation rate tumours. 

    About Tebentafusp

    Tebentafusp is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. Tebentafusp specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma, and is the first molecule developed using Immunocore's ImmTAC technology platform designed to redirect and activate T cells to recognise and kill tumour cells. Tebentafusp has been granted Breakthrough Therapy Designation, Fast Track designation and orphan drug designation by the FDA in the United States and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. For more information about enrolling tebentafusp clinical trials for metastatic uveal melanoma, please visit ClinicalTrials.gov (NCT03070392).

    About Uveal Melanoma

    Uveal melanoma is a rare and aggressive form of melanoma, which affects the eye. Metastatic uveal melanoma typically has a poor prognosis and has no currently accepted optimal management or treatment. Although it is the most common primary intraocular malignancy in adults, the diagnosis is rare, with approximately 8,000 new patients diagnosed globally each year (1,600-2,000 cases per year in the United States). Up to 50% of people with uveal melanoma will eventually develop metastatic disease. When the cancer spreads beyond the eye, only approximately half of patients will survive for one year.

    Forward Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but are not limited to, statements regarding the efficacy, safety and therapeutic potential of tebentafusp, the design, progress, timing, scope and results of the Company's clinical trials including IMCgp100-202, the anticipated timing of disclosure of results of clinical trials, plans for initiating future clinical trials and extension studies, the progress of the Company's development programs including tebentafusp, the potential benefit of Breakthrough Therapy Designation or Orphan Drug Designation for tebentafusp, the timing of regulatory filings including estimates regarding the planned submission a BLA for tebentafusp, the likelihood of obtaining regulatory approval of any of the Company's product candidates including tebentafusp, and the regulatory approval path for tebentafusp. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, many of which are beyond the Company's control. These risks and uncertainties include, but are not limited to, the impacts of the COVID-19 pandemic on the Company's business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; and the uncertainties and timing of the regulatory approval process. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 25, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the Company's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information except as required by law.

    CONTACT: 

    Immunocore

    Debra Nielsen, Head of Communications

    T: +1 (610) 368-8602

    E: debra.nielsen@immunocore.com

    Follow on Twitter: @Immunocore

    Consilium Strategic Communications (corporate and financial)

    Mary-Jane Elliott/ Chris Welsh/Jessica Hodgson

    T: +44 (0)203 709 5700

    E: Immunocore@consilium-comms.com

    Investor Relations  

    Clayton Robertson, Head of Investor Relations

    T: +1 215-384-4781

    E: ir@immunocore.com



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  10. PRESS RELEASE

    Immunocore to present at upcoming investor conferences

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 27 May 2021) Immunocore (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease, today announces that management will present at the following investor conferences in June.

    • Jefferies Virtual Healthcare Conference

    Fireside Chat: Thursday, June 3, 2021 at 8:00 a.m. ET

    • Goldman Sachs 42nd Annual Global Healthcare Conference

    Fireside Chat: Wednesday, June 9, 2021 at 10:30 am ET

    The investor conferences will each be held in…

    PRESS RELEASE

    Immunocore to present at upcoming investor conferences

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 27 May 2021) Immunocore (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease, today announces that management will present at the following investor conferences in June.

    • Jefferies Virtual Healthcare Conference



    Fireside Chat: Thursday, June 3, 2021 at 8:00 a.m. ET

    • Goldman Sachs 42nd Annual Global Healthcare Conference



    Fireside Chat: Wednesday, June 9, 2021 at 10:30 am ET

    The investor conferences will each be held in a virtual format and a live webcast of each fireside chat can be accessed in the ‘Investors' section of Immunocore's website at www.immunocore.com. For conferences that offer replays, presentations will be made available for a limited time.

    ##

    About Immunocore

    Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, infectious and autoimmune. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs. Immunocore's most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies.

    Forward Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but are not limited to, statements regarding the efficacy, safety and therapeutic potential of tebentafusp, the design, progress, timing, scope and results of the Company's clinical trials including IMCgp100-202, the anticipated timing of disclosure of results of clinical trials, plans for initiating future clinical trials and extension studies, the progress of the Company's development programs including tebentafusp, the potential benefit of Breakthrough Therapy Designation or Orphan Drug Designation for tebentafusp, the timing of regulatory filings including estimates regarding the planned submission a BLA for tebentafusp, the likelihood of obtaining regulatory approval of any of the Company's product candidates including tebentafusp, and the regulatory approval path for tebentafusp. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, many of which are beyond the Company's control. These risks and uncertainties include, but are not limited to, the impacts of the COVID-19 pandemic on the Company's business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; and the uncertainties and timing of the regulatory approval process. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 25, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the Company's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information except as required by law.

    CONTACT: 

    Immunocore

    Debra Nielsen, Head of Communications

    T: +1 (610) 368-8602

    E: debra.nielsen@immunocore.com

    Follow on Twitter: @Immunocore

    Consilium Strategic Communications (corporate and financial)

    Mary-Jane Elliott/ Chris Welsh/Jessica Hodgson

    T: +44 (0)203 709 5700

    E: Immunocore@consilium-comms.com

    Investor Relations  

    Clayton Robertson, Head of Investor Relations

    T: +1 215-384-4781

    E: ir@immunocore.com



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  11. PRESS RELEASE

    Immunocore announces dosing of first patient with ImmTAV® bispecific molecule for chronic Hepatitis B

    IMC-I109V studied for the treatment of non-cirrhotic
    HBeAg-negative chronic hepatitis B (HBV) infection

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 18 May 2021) Immunocore Holdings Plc (NASDAQ:IMCR) (or the "Company"), a pioneering, clinical‐stage T cell receptor biotechnology company working to develop and commercialise a new generation of transformative medicines to address unmet needs in cancer, infection and autoimmune disease, today announces the dosing of the first patient in the first-in-human clinical trial of IMC-I109V, a new class of bispecific protein immunotherapy that is being developed for…

    PRESS RELEASE

    Immunocore announces dosing of first patient with ImmTAV® bispecific molecule for chronic Hepatitis B

    IMC-I109V studied for the treatment of non-cirrhotic

    HBeAg-negative chronic hepatitis B (HBV) infection

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 18 May 2021) Immunocore Holdings Plc (NASDAQ:IMCR) (or the "Company"), a pioneering, clinical‐stage T cell receptor biotechnology company working to develop and commercialise a new generation of transformative medicines to address unmet needs in cancer, infection and autoimmune disease, today announces the dosing of the first patient in the first-in-human clinical trial of IMC-I109V, a new class of bispecific protein immunotherapy that is being developed for the treatment of patients with chronic hepatitis B (HBV) infection (CHB). Wholly owned IMC-I109V is the first candidate in development using Immunocore's immune‐mobilising monoclonal T cell receptors against virus (ImmTAV®) platform to enter clinical trials.

    "Our aim, through this study, is to obtain further data assessing the safety and potential of this bispecific T cell receptor (TCR) to provide a functional cure for people with CHB," commented Professor Man-Fung Yuen, Chief of Division of Gastroenterology & Hepatology, Department of Medicine, The University of Hong Kong/Queen Mary Hospital and a principal investigator of the study. "Approximately one third of the world's population shows serological evidence of past or present infection with HBV and 240 million people are chronic carriers of the virus. Among patients with CHB, 25% will develop primary liver cancer or cirrhosis. Current treatment options require lifelong adherence to be effective, presenting us with an urgent need for new and innovative therapeutic options."

    The trial is an open label study evaluating the safety, antiviral activity, and pharmacokinetics of IMC-I190V in HLA-A*02:01 positive patients with Chronic HBV who are non-cirrhotic, hepatitis B antigen-negative, and virally suppressed.

    IMC-I109V is an immunotherapeutic approach designed to potentially and specifically eliminate HBV-infected hepatocytes expressing hepatitis B surface antigen (HBsAg) via T cell redirection. IMC-I109V is designed to overcome T cell dysfunction by recruiting non-exhausted T cells to eliminate hepatocytes harbouring covalently closed circular DNA or integrated HBV DNA. Elimination of these cells is necessary to achieve a state of ‘Functional Cure' defined as sustained HBsAg loss in addition to undetectable HBV DNA 6 months post-treatment.

    - Ends -

    About ImmTAV molecules and infectious diseases

    ImmTAV (Immune mobilising mTCR Against Virus) molecules are novel bispecific molecules that, like ImmTAC (Immune mobilising monoclonal TCRs Against Cancer) molecules, are designed to enable the immune system to recognize and eliminate virally infected cells.

    Immunocore aims to achieve sustained loss of circulating viral antigens and markers of viral replication after stopping medication for people living with chronic hepatitis B. This is known as "functional cure."

    About Immunocore

    Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, infectious and autoimmune. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs. Immunocore's most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies.

    Forward Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but are not limited to, statements regarding the Company's business strategy including its proposed regulatory plans for tebentafusp, the efficacy, safety and therapeutic potential of tebentafusp, the planned submission of a BLA submission for tebentafusp for the treatment of mUM, the potential approval and commercial launch of tebentafusp for mUM, the design, progress, timing, scope and results of the Company's clinical trials including IMC-C103C, IMC-F106C and IMC-I109V, the potential benefit of Breakthrough Therapy Designation or Orphan Drug Designation for tebentafusp, and the Company's anticipated cash runway. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, many of which are beyond the Company's control. These risks and uncertainties include, but are not limited to, the impacts of the COVID-19 pandemic on the Company's business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; and the uncertainties and timing of the regulatory approval process. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in the Company's Annual Report on Form 20-F for the year ended December 31, 2021 filed with the Securities and Exchange Commission on March 25, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the Company's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information, except as required by law.

    CONTACT: 

    Immunocore

    Debra Nielsen, Head of Communications

    T: +1 (610) 368-8602

    E: debra.nielsen@immunocore.com

    Follow on Twitter: @Immunocore

    Consilium Strategic Communications (corporate and financial)

    Mary-Jane Elliott/ Chris Welsh/ Jessica Hodgson

    T: +44 (0)203 709 5700

    E: Immunocore@consilium-comms.com

    Investor Relations  

    Clayton Robertson, Head of Investor Relations

    T: +1 215-384-4781

    E: ir@immunocore.com



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  12. PRESS RELEASE

    Immunocore Reports First Quarter 2021 Financial Results

    Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) is expected to be completed in third quarter of 2021

    Launched a global early access program for tebentafusp in metastatic uveal melanoma

    Cash position of $431 million as of March 31, 2021 includes $287 million in net proceeds from initial public offering and concurrent private placement in February 2021

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 12 May 2021) Immunocore Holdings Plc (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad…

    PRESS RELEASE

    Immunocore Reports First Quarter 2021 Financial Results

    Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) is expected to be completed in third quarter of 2021

    Launched a global early access program for tebentafusp in metastatic uveal melanoma

    Cash position of $431 million as of March 31, 2021 includes $287 million in net proceeds from initial public offering and concurrent private placement in February 2021

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 12 May 2021) Immunocore Holdings Plc (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, today announced its results for the quarter ended March 31, 2021.

    Highlights for the quarter included the presentation of the Phase 3 randomized data from the Company's lead candidate tebentafusp in the plenary clinical trial session at the American Association for Cancer Research (AACR) Annual Meeting, the launch of a global early access program for tebentafusp, and the successful completion of the Company's initial public offering resulting in net proceeds of $287 million.

    Bahija Jallal, Chief Executive Officer of Immunocore, said: "Tebentafusp has been demonstrated to prolong survival in patients with metastatic uveal melanoma, a cancer that has historically proven insensitive to chemotherapy and immunotherapies. These data, recently presented at AACR, represent the first positive Phase 3 clinical trial for a TCR therapeutic and the first time that a bispecific T cell engager has demonstrated a survival benefit in a solid tumor, representing a significant breakthrough in the field of oncology."

    First Quarter 2021 Highlights (including post-period)

    Tebentafusp

    In April, one oral presentation and three posters on tebentafusp were accepted at the 2021 American Society of Oncology (ASCO) Annual Meeting being held virtually from June 4-8, 2021. Per ASCO's Embargo & Release Information, full abstracts will be released to the public on ASCO's Meeting Library at 5:00 p.m. ET on May 19, 2021.

    In April, the Company launched a global early access program for tebentafusp in metastatic uveal melanoma (mUM).

    In April, the Company's Phase 3 data of tebentafusp in metastatic uveal melanoma was also the subject of an oral presentation in the Phase 3 clinical trials plenary session at the AACR Virtual Annual Meeting 2021. Tebentafusp demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) as a first-line treatment in mUM. In the intent-to-treat population, tebentafusp demonstrated a median overall survival of 21.7 months compared to 16.0 months for investigator's choice and with 73% of patients alive at 1 year for tebentafusp vs. 58% for investigator's choice. The OS Hazard Ratio (HR) favored tebentafusp, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator's choice (82% pembrolizumab; 12% ipilimumab; 6% dacarbazine). In addition, tebentafusp resulted in a statistically significant longer PFS. Treatment-related adverse events were manageable and consistent with the proposed mechanism.   

    In February, tebentafusp was granted Breakthrough Therapy Designation by the U.S. Food & Drug Administration (FDA) for unresectable or metastatic uveal melanoma. Additionally, the European Commission, upon recommendation of the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) awarded tebentafusp Orphan Drug Designation for the treatment of uveal melanoma. Medicines that meet the EMA's Orphan Drug Designation criteria qualify for several incentives, including 10 years of market exclusivity, protocol assistance, and potentially reduced fees for regulatory activities.

    Immunocore will be working to complete its BLA submission to the FDA in the third quarter of 2021, followed by submission of a Marketing Authorization Application to the EMA.

    Additional Clinical Programs

    IMC-C103C – MAGE-A4

    In the first quarter, the Company continued to advance, IMC-C103C, an ImmTAC molecule targeting an HLA-A*02:01 MAGE-A4 antigen, in a first-in-human, Phase 1/2 dose escalation trial in patients with solid tumor cancers including non-small-cell lung cancer (NSCLC), gastric, head and neck, ovarian and synovial sarcoma. The Company plans to report Phase 1 initial data from this trial in the fourth quarter of 2021.

    IMC-F106C – PRAME

    In the first quarter, the Company continued to advance IMC-F106C, an ImmTAC molecule targeting an HLA-A*02:01 PRAME antigen, in a first-in-human, Phase 1/2 dose escalation trial in patients with multiple solid tumor cancers. PRAME is overexpressed in many solid tumors including NSCLC, SCLC, endometrial, ovarian, and breast cancers. The Company plans to report Phase 1 initial data from this trial in mid-2022.

    IMC-I109VHBV

    In the first quarter, the Company continued to advance IMC-I109V, an ImmTAV molecule targeting a conserved Hepatitis B virus (HBV), envelope antigen, in a global Phase 1 single ascending dose trial. The Company plans to initiate dosing mid-year 2021.

    Operational Highlights

    In February, the Company made key appointments to management and Board of Directors. The appointment of Ralph Torbay as Immunocore's new Head of Commercial and the appointment of Dr. Roy S. Herbst as a member of the Company's Board of Directors became effective January 28, 2021. Dr. Herbst served as a member of Immunocore's Scientific Advisory Board (SAB) and is currently Ensign Professor of Medicine (Medical Oncology), Professor of Pharmacology, Chief of Medical Oncology and Associate Cancer Center Director for Translational Research at Yale Cancer Center and Smilow Cancer Hospital.

    In February, the Company completed its initial public offering (IPO) and concurrent private placement. The financing was $312.1 million in aggregate, of which approximately $287 million in net proceeds was from the IPO on Nasdaq of 11,426,280 American Depositary Shares (ADSs), including the exercise in full by the underwriters of their option to purchase an additional 1,490,384 ADSs, at an IPO price of $26.00 per ADS and $15 million from the completion of the concurrent sale of an additional 576,923 ADSs at the initial offering price of $26.00 per ADS, for gross proceeds of approximately $15.0 million, in a private placement to the Bill & Melinda Gates Foundation.

    Financial Results

    Basic and diluted loss per share was a £0.76 or $1.05 for the quarter ended March 31, 2021 compared to an adjusted to £0.74 for the quarter ended March 31, 2020. Total operating loss for the quarter was £31.9 million or $44.0 million compared to £22.1 million for the same period last year, largely due to an increase in employee costs associated with non-cash share-based payment charges.

    For the three months ended March 31, 2021, revenue from collaboration agreements was unchanged at £8.3 million or $11.4 million compared to the same period last year. For the three months ended March 31, 2021, research and development expenses were £19.9 million or $27.4 million, as compared to £20.8 million for the three months ended March 31, 2020. For the quarter, administrative expenses were £20.2 million or $27.8 million compared to £9.6 million for the quarter ended March 31, 2020 including a £7.7 million increase in the non-cash share-based payment charges.

    Cash and cash equivalents totaled £313.1 million or approximately $431 million as of March 31, 2021 compared to £68.4 million for the same period last year.

    ##

    About Immunocore

    Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, infectious and autoimmune. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs. Immunocore's most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies.

    Forward Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but are not limited to, statements regarding the Company's business strategy including its proposed regulatory plans for tebentafusp, the efficacy, safety and therapeutic potential of tebentafusp, the planned submission of a BLA submission for tebentafusp for the treatment of mUM, the potential approval and commercial launch of tebentafusp for mUM, the design, progress, timing, scope and results of the Company's clinical trials including IMC-C103C, IMC-F106C and IMC-I109V, the potential benefit of Breakthrough Therapy Designation or Orphan Drug Designation for tebentafusp, and the Company's anticipated cash runway. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, many of which are beyond the Company's control. These risks and uncertainties include, but are not limited to, the impacts of the COVID-19 pandemic on the Company's business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; and the uncertainties and timing of the regulatory approval process. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in the Company's Annual Report on Form 20-F for the year ended December 31, 2021 filed with the Securities and Exchange Commission on March 25, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the Company's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information, except as required by law.

    CONTACT: 

    Immunocore

    Debra Nielsen, Head of Communications

    T: +1 (610) 368-8602

    E: debra.nielsen@immunocore.com

    Follow on Twitter: @Immunocore

    Consilium Strategic Communications (corporate and financial)

    Mary-Jane Elliott/ Chris Welsh/ Jessica Hodgson

    T: +44 (0)203 709 5700

    E: Immunocore@consilium-comms.com

    Investor Relations  

    Clayton Robertson, Head of Investor Relations

    T: +1 215-384-4781

    E: ir@immunocore.com



    Comparison of the Three Months Ended March 31, 2021 and 2020



    Consolidated Statement of Loss for Each Period Presented:

     Three Months Ended March 31
     2021 2020
     $000 £000 £000
     (unaudited)
    Revenue11,408 8,270 8,255
    Research and development expenses(27,431) (19,885) (20,779)
    Administrative expenses(27,844) (20,184) (9,605)
    Net other operating (expense) / income(113) (82) 10
    Operating loss(43,980) (31,881) (22,119)
    Finance income30 22 1,383
    Finance costs(2,565) (1,860) (1,067)
    Non-operating (expense) / income(2,535) (1,838) 316
    Loss before taxes(46,515) (33,719) (21,803)
    Income tax credit6,457 4,681 3,164
    Loss for the period(40,058) (29,038) (18,639)



     For the three months ended



    March 31

    2021
     For the three months ended



    March 31,

    2020
    Loss for the period (£000's)(29,038) (18,639)
    Basic and diluted weighted average number of shares38,451,332 25,263,027
    Basic and diluted loss per share (£) (1)(0.76) (0.74)



    Condensed Consolidated Statement of Cash Flows for Each Period Presented:

     Three Months Ended March 31,
     2021 2021 2020
     $000 £000 £000
        (unaudited)  
    Cash and cash equivalents at beginning of year178,943 129,716 73,966
    Net cash flows used in operating activities(35,838) (25,979) (30,518)
    Net cash flows from / (used in) investing activities34 25 (1,334)
    Net cash flows from financing activities288,830 209,373 26,149
    Net foreign exchange difference on cash held(72) (52) 114
    Cash and cash equivalents at end of period431,897 313,083 68,377



    Consolidated Statements of Financial Position for Each Period Presented:

     March 31,

    2021

    £'000
     December 31,

    2020

    £'000
    Non-current assets   
    Property, plant and equipment12,321 13,754
    Right of use assets22,742 23,093
    Investment in sub-lease540 776
    Other non-current financial assets3,812 4,410
    Deferred tax asset2,213 2,230
    Total non-current assets41,628 44,263
    Current assets   
    Trade and other receivables8,821 10,280
    Tax receivable17,615 12,935
    Cash and cash equivalents313,083129,716
    Total current assets339,519152,931
    Total assets381,147197,194
    Equity   
    Share capital88 64
    Share premium211,286 -
    Foreign currency translation reserve71 163
    Other reserves386,167 386,167
    Share-based payment reserve27,092 18,821
    Accumulated deficit(378,907) (349,869)
    Total equity245,797 55,346
    Non-current liabilities   
    Interest-bearing loans and borrowings36,437 36,654
    Deferred liabilities19,225 24,868
    Lease liabilities25,035 25,190
    Provisions160 138
    Total non-current liabilities80,857 86,850
    Current liabilities   
    Interest-bearing loans and borrowings546 ---
    Trade and other payables26,359 25,728
    Deferred liabilities25,710 27,118
    Lease liabilities1,764 2,043
    Provisions114 109
    Total current liabilities54,493 54,998
    Total liabilities135,350 141,848
    Total equity and liabilities381,147 197,194







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  13. PRESS RELEASE

    Immunocore Announces Upcoming Presentations at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting

    Overall survival benefit from tebentafusp in patients with best response
    of progressive disease subject of oral presentation

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 28 April 2021) Immunocore (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease, today announced it will deliver an oral presentation and three posters at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting being held virtually…

    PRESS RELEASE

    Immunocore Announces Upcoming Presentations at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting

    Overall survival benefit from tebentafusp in patients with best response

    of progressive disease subject of oral presentation

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 28 April 2021) Immunocore (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease, today announced it will deliver an oral presentation and three posters at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting being held virtually from June 4-8, 2021.

    CLINICAL SCIENCE SYMPOSIUM

    Title: Overall survival benefit from tebentafusp in patients with best response of progressive disease

    Date and Time: June 4, 2021; 9:00 a.m.

    Session: Management of Rare Melanoma Subtypes

    Abstract ID: 9509

    POSTER PRESENTATIONS

    Title: Co-primary endpoint of overall survival for tebentafusp (tebe)-induced rash in a Phase 3 randomized trial comparing tebe vs. investigator's choice (IC) in first line metastatic uveal melanoma

    Session: Melanoma/Skin Cancers

    Abstract ID: 9527

    Title: Overall survival in patients who received checkpoint inhibitors after completing tebentafusp in a phase 3 randomized trial of first line metastatic uveal melanoma

    Session: Melanoma/Skin Cancers

    Abstract ID: 9526

    Title: Characterization of cytokine release syndrome (CRS) following treatment with tebentafusp in patients (pts) with previously treated (2L+) metastatic uveal melanoma (mUM).

    Session: Melanoma/Skin Cancers

    Abstract ID: 9531

    Due to the virtual format, all oral, poster, and poster discussion sessions, as well as track-based Clinical Science Symposia, will be available on demand, beginning June 4, 2021 at 9 a.m. EDT, for registered attendees of the conference.

    About Immunocore

    Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, infectious and autoimmune. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs. Immunocore's most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies.

    About Tebentafusp

    Tebentafusp is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. Tebentafusp specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma, and is the first molecule developed using Immunocore's ImmTAC technology platform designed to redirect and activate T cells to recognise and kill tumour cells. Tebentafusp has been granted Fast Track Designation and orphan drug designation by the FDA in the United States and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. For more information about enrolling tebentafusp clinical trials for metastatic uveal melanoma, please visit ClinicalTrials.gov (NCT03070392).

    Forward Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but are not limited to, statements regarding the efficacy, safety and therapeutic potential of tebentafusp, the results, conduct, progress and timing of the Company's development programs including tebentafusp, the potential benefit of Breakthrough Therapy Designation for tebentafusp, estimates regarding the planned submission a BLA for tebentafusp and the regulatory approval path for tebentafusp. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, many of which are beyond the Company's control. These risks and uncertainties include, but are not limited to, the impacts of the COVID-19 pandemic on the Company's business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; and the uncertainties and timing of the regulatory approval process. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in in the Company's final prospectus dated February 4, 2021 filed with the Securities and Exchange Commission pursuant to Rule 424(b)(4) on February 8, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the Company's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information except as required by law.

    CONTACT: 

    Immunocore

    Debra Nielsen, Head of Communications

    T: +1 (610) 368-8602

    E: debra.nielsen@immunocore.com

    Follow on Twitter: @Immunocore

    Consilium Strategic Communications (corporate and financial)

    Mary-Jane Elliott/ Chris Welsh/ Jessica Hodgson

    T: +44 (0)203 709 5700

    E: Immunocore@consilium-comms.com

    Investor Relations  

    Clayton Robertson, Head of Investor Relations

    T: +1 215-384-4781

    E: ir@immunocore.com



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  14.  PRESS RELEASE

    Immunocore presents phase 3 data comparing tebentafusp with investigator's choice in the clinical trial plenary session at the
     American Association for Cancer Research 2021 Annual Meeting

    Tebentafusp is the first investigational therapy to improve Overall Survival (OS) in patients with metastatic uveal melanoma

    First positive Phase 3 clinical trial for any T cell receptor therapeutic and first for any bispecific in a solid tumor  

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 12 April 2021) Immunocore (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including…

     PRESS RELEASE

    Immunocore presents phase 3 data comparing tebentafusp with investigator's choice in the clinical trial plenary session at the

     American Association for Cancer Research 2021 Annual Meeting

    Tebentafusp is the first investigational therapy to improve Overall Survival (OS) in patients with metastatic uveal melanoma

    First positive Phase 3 clinical trial for any T cell receptor therapeutic and first for any bispecific in a solid tumor  

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 12 April 2021) Immunocore (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, presented data from a phase 3 randomized trial comparing tebentafusp (IMCgp100) with investigator's choice in first-line metastatic uveal melanoma (mUM) in the clinical trial plenary session at the American Association for Cancer Research (AACR) Annual Meeting 2021.

    Tebentafusp demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) as a first-line treatment in mUM.  The OS Hazard Ratio (HR) in the intent-to-treat population favored tebentafusp, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator's choice (82% pembrolizumab; 12% ipilimumab; 6% dacarbazine). Treatment-related adverse events were manageable and consistent with the proposed mechanism.

    "This is the first investigational therapy to demonstrate improved OS in metastatic uveal melanoma," said Bahija Jallal, Chief Executive Officer of Immunocore. "We believe these data demonstrate that tebentafusp has the potential to provide a meaningful difference in the treatment of metastatic uveal melanoma, a highly aggressive disease for which there is no effective standard of care."

    In a separate oral presentation on Monday April 12, Marcus O. Butler shared an analysis of previously treated uveal melanoma patients who had prolonged survival.

    Two posters from the phase 2 IMCgp100-102 study are also available for on-demand viewing at the AACR website.  These analyses investigated the proposed mechanism of action (MoA), including inducing an increase in cytokines and T cell trafficking into the tumor.

    Tebentafusp has been granted Breakthrough Therapy Designation, Fast Track designation and orphan drug designation by the U.S. Food and Drug Administration (FDA) and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. Immunocore will be working with the FDA to complete submission of a BLA for tebentafusp in the third quarter of 2021.

    The Company will host a conference call for industry, health and investment professionals on Tuesday, April 13th at 7:30 am ET to discuss the phase 3 IMCgp100-202 trial. The webcast can be accessed directly through this link. A replay of the webcast will be made available shortly after the conclusion of the call and archived on the Investor Relations section of the Company's website for at least 90 days.

    PLENARY AND ORAL PRESENTATIONS

    Title: Phase 3 randomized trial comparing tebentafusp with investigator's choice in first line metastatic uveal melanoma

    • Date and Time: Plenary session presentation (CT002), Saturday April 10th at 11:30am - 1:30pm ET
    • Presenter: Jessica C. Hassel (PI), University Hospital Heidelberg, Heidelberg, Germany
    • Abstract #: 5342
    • Session Title: Phase III Clinical Trials

    Title: Kinetics of radiographic response for tebentafusp (tebe) in previously treated metastatic uveal melanoma (mUM) patients (pts) achieving prolonged survival

    • Date and Time: Oral presentation (CT038), Monday April 12th at 1:30pm – 3:15pm ET
    • Presenter: Marcus O. Butler (PI), Princess Margaret Cancer Centre, Toronto, ON, Canada
    • Abstract #: 5338
    • Session Title: Disease-Oriented Innovative Clinical Research and Trials

    POSTER PRESENTATIONS

    TitleTebentafusp induces transient systemic inflammation and modifies the micro-environment to sensitize uveal melanoma tumors to cytotoxic CD8 cells

    • Poster #517
    • Presenter: Marcus O. Butler (PI)

    Title: Uveal melanoma study patients with low CD163:CD3 ratio in tumor biopsy and low serum IL-6 showed enhanced tumor shrinkage (TS) and overall survival (OS) on tebentafusp

    • Poster #1673
    • Presenter: Jessica Hassel (PI)

    ##

    About Immunocore

    Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, infectious and autoimmune. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs. Immunocore's most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies.

    About ImmTAC® Molecules

    Immunocore's proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilising monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognise and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognise intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an anti-CD3 immune-activating effector function. Based on the demonstrated mechanism of T cell infiltration into human tumours, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumours, regardless of mutational burden or immune infiltration, including immune "cold" low mutation rate tumours. 

    About Tebentafusp

    Tebentafusp is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. Tebentafusp specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma, and is the first molecule developed using Immunocore's ImmTAC technology platform designed to redirect and activate T cells to recognise and kill tumour cells. Tebentafusp has been granted Breakthrough Therapy Designation, Fast Track designation and orphan drug designation by the FDA in the United States and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. For more information about enrolling tebentafusp clinical trials for metastatic uveal melanoma, please visit ClinicalTrials.gov (NCT03070392).

    About Uveal Melanoma

    Uveal melanoma is a rare and aggressive form of melanoma, which affects the eye. Metastatic uveal melanoma typically has a poor prognosis and has no currently accepted optimal management or treatment. Although it is the most common primary intraocular malignancy in adults, the diagnosis is rare, with approximately 8,000 new patients diagnosed globally each year (1,600-2,000 cases per year in the United States). Up to 50% of people with uveal melanoma will eventually develop metastatic disease. When the cancer spreads beyond the eye, only approximately half of patients will survive for one year.

    Forward Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but are not limited to, statements regarding the efficacy, safety and therapeutic potential of tebentafusp, the design, progress, timing, scope and results of the Company's clinical trials including IMCgp100-202, the anticipated timing of disclosure of results of clinical trials, plans for initiating future clinical trials and extension studies, the progress of the Company's development programs including tebentafusp, the potential benefit of Breakthrough Therapy Designation or Orphan Drug Designation for tebentafusp, the timing of regulatory filings including estimates regarding the planned submission a BLA for tebentafusp, the likelihood of obtaining regulatory approval of any of the Company's product candidates including tebentafusp, and the regulatory approval path for tebentafusp. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, many of which are beyond the Company's control. These risks and uncertainties include, but are not limited to, the impacts of the COVID-19 pandemic on the Company's business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; and the uncertainties and timing of the regulatory approval process. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 25, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the Company's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information except as required by law.

    CONTACT: 

    Immunocore

    Debra Nielsen, Head of Communications

    T: +1 (610) 368-8602

    E: debra.nielsen@immunocore.com

    Follow on Twitter: @Immunocore

    Consilium Strategic Communications (corporate and financial)

    Mary-Jane Elliott/ Chris Welsh/ Sukaina Virji/Jessica Hodgson

    T: +44 (0)203 709 5700

    E: Immunocore@consilium-comms.com

    Investor Relations  

    Clayton Robertson, Head of Investor Relations

    T: +1 215-384-4781

    E: ir@immunocore.com



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  15. Immunocore Provides Business Update and Reports Full Year 2020 Financial Results

    Breakthrough Therapy Designation granted by the FDA for tebentafusp in unresectable or metastatic uveal melanoma

    Tebentafusp Phase 3 randomized trial data subject of an oral presentation at
    the American Association for Cancer Research (AACR) 2021 Annual Meeting

    Cash position of $177 million as of December 31, 2020 with an additional $287 million in net proceeds from initial public offering and concurrent private placement in February 2021

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 25 March 2021) Immunocore (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific





    Immunocore Provides Business Update and Reports Full Year 2020 Financial Results

    Breakthrough Therapy Designation granted by the FDA for tebentafusp in unresectable or metastatic uveal melanoma



    Tebentafusp Phase 3 randomized trial data subject of an oral presentation at

    the American Association for Cancer Research (AACR) 2021 Annual Meeting

    Cash position of $177 million as of December 31, 2020 with an additional $287 million in net proceeds from initial public offering and concurrent private placement in February 2021

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 25 March 2021) Immunocore (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, today announced its results for the full year ended December 31, 2020.

    2020 Highlights (including post-period)

    • Lead product candidate tebentafusp demonstrated superior overall survival (OS) in a Phase 3 randomized clinical trial in metastatic uveal melanoma (mUM) where the OS Hazard Ratio (HR) in the intent-to-treat population favored tebentafusp, HR=0.51 (95% CI: 0.36, 0.71). Tebentafusp was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for unresectable or metastatic uveal melanoma, and the Company anticipates completion of the submission of a Biologics License Application (BLA) in the third quarter of 2021.

       
    • Continued development of ImmTAC (Immune mobilizing monoclonal T-cell receptors Against Cancer) clinical portfolio for multiple tumor types; IMC-C103C is currently in the dose escalation phase of a Phase 1 clinical trial in MAGE-A4 expressing solid tumors, with initial data expected to be presented in the second half of 2021; IMC-F106C is currently in a Phase 1 study in patients with PRAME-expressing solid tumors, with initial data expected to be presented mid-year 2022.

       
    • Dosing in a Phase 1 clinical trial for patients with chronic hepatitis B virus (HBV) is anticipated for mid-year 2021.

       
    • Cash position of $177 million as of December 31, 2020 with an additional $287 million in net proceeds raised from the Company's initial public offering and a concurrent private placement in February 2021.

                             

    Bahija Jallal, Chief Executive Officer of Immunocore, said: "Reflecting on 2020, we have made great strides in the clinical advancement of TCR therapeutics. We believe the tebentafusp clinical data represent the first positive Phase 3 clinical trial for a TCR therapeutic and the first bispecific immune-oncology therapy with demonstrated overall survival advantage in any solid tumor. These results were a culmination of disciplined work by the Immunocore team and strong support by our investors. Our initial public offering in February enables us to accelerate the development of our pipeline of TCR therapeutics and the planned BLA submission of our lead candidate tebentafusp in patients with uveal melanoma, as well as begin early commercialization activities assuming regulatory approval."

    Key Pipeline Updates

    Tebentafusp

    In November 2020, the Company announced tebentafusp achieved the primary endpoint of superior overall survival compared to investigator's choice in a randomized Phase 3 clinical trial (IMCgp100-202) in previously untreated metastatic uveal melanoma, a cancer that has historically proven to be insensitive to chemotherapy and other immunotherapies. The 378-patient study was unblinded by an independent data monitoring committee at the first pre-planned interim analysis when the OS Hazard Ratio (HR) in the intent-to-treat population favored tebentafusp, HR=0.51 (95% CI: 0.36, 0.71); p< 0.0001, over investigator's choice (82% pembrolizumab; 12% ipilimumab; 6% dacarbazine). Immunocore will be working with the FDA to facilitate complete submission of a BLA for tebentafusp in the third quarter of 2021, followed by Marketing Authorization Application submission to the European Medicines Agency (EMA).

    In February 2021, tebentafusp was granted Breakthrough Therapy Designation by the FDA for unresectable or metastatic uveal melanoma. Additionally, in February 2021, the European Commission, upon recommendation of the EMA's Committee for Orphan Medicinal Products (COMP) awarded tebentafusp Orphan Drug Designation for the treatment of uveal melanoma. Medicines that meet the EMA's Orphan Drug Designation criteria qualify for several incentives, including ten years of market exclusivity, protocol assistance, and potentially reduced fees for regulatory activities.

    In March 2021, the Company announced that Phase 3 data from IMCgp100-202 Phase 3 clinical trial would be the subject of an oral presentation in the Phase 3 clinical trials plenary session at the AACR Annual Meeting 2021 which will be held virtually on April 10, 2021.

    Additional Clinical Programs

    IMC-C103C - MAGE-A4

    As of year-end 2020, 21 patients had been dosed in the dose escalation portion of the IMC-C103C Phase 1/2 clinical trial in patients with solid tumors. Early pharmacodynamics data indicate that IMC-C103C monotherapy is demonstrating biological activity at the doses currently under evaluation. The Company plans to present Phase 1 data from this trial in the second half of 2021.

    The Company believes that IMC-C103C is the only clinical stage off-the-shelf therapy candidate in development against MAGE-A4—an X-chromosome-linked cancer/testis protein that is broadly expressed across a range of cancer indications, including non-small-cell lung cancer, among others. IMC-C103C is part of a co-development/co-promotion collaboration with Genentech under which Immunocore shares program costs and profits equally.

    IMC-F106C – PRAME

    As of year-end 2020, nine patients had been dosed in the dose escalation portion of the IMC-F106C Phase 1/2 clinical trial. The trial is designed to study the safety and preliminary activity of IMC-F106C as a monotherapy in patients with PRAME-expressing solid tumors. The Company plans to report initial Phase 1 data from this trial in mid-2022.

    IMC-F106C is an ImmTAC targeting a PRAME derived peptide presented by HLA-A*02:01 and is the first off-the-shelf therapeutic targeting PRAME. PRAME has the highest expression frequency of all cancer/testis antigens across a range of solid and hematologic cancers, notably non-small-cell lung cancer, and its expression is generally identified as a poor prognostic feature. Immunocore retains full rights to IMC-F106C.

    IMC-I109V – HBV

    In August 2020, the Company announced the publication of novel therapeutic approach with the potential to provide a functional cure for chronic hepatitis B, in leading peer-reviewed journal, Hepatology. These data support on-target efficacy of the lead HBV ImmTAV against HBV-infected hepatocytes. The Company plans to initiate dosing in the single ascending dosing portion of the trial in mid-2021.

    IMC-M113V – HIV

    In 2020, the Company advanced IMC-M113V through GMP manufacturing and IND supporting pre-clinical studies for human immunosuppression virus (HIV). The Company's HIV programs are funded by the Bill & Melinda Gates Foundation, and regulatory submission to enable clinical testing is anticipated in the second half of 2021.

    GSK-01– NY-ESO

    The GSK-01 NY-ESO Phase 1 dose escalation study to determine safety, and which is enrolling several different tumor types, is still ongoing. An expansion phase was planned to initiate once the Phase 1 dose escalation was complete. However, following a portfolio review, Immunocore, in collaboration with GSK, have jointly elected not to plan for or initiate the efficacy determining expansion phase of the trial. The expansion arm was planned to be conducted in synovial sarcoma, an ultra-rare disease which is already addressed by other assets in the Company's portfolio including MAGE-A4 and PRAME. Consequently, GSK has forgone their option to acquire an exclusive license to the NY-ESO program and Immunocore will retain ownership of the asset. Immunocore plans to present the data from the Phase 1 study in 2022.

    Corporate Updates

    Fundraising and initial public offering on Nasdaq

    In February 2021, the Company raised $312.1 million in aggregate financing and approximately $287 million in net proceeds from its initial public offering on Nasdaq of 11,426,280 American Depositary Shares (ADSs), including the exercise in full by the underwriters of their option to purchase an additional 1,490,384 ADSs, at an initial public offering price of $26.00 per ADS. In addition to the ADSs sold in the public offering, Immunocore announced the completion of the concurrent sale of an additional 576,923 ADSs at the initial offering price of $26.00 per ADS, for gross proceeds of approximately $15 million, in a private placement to the Bill & Melinda Gates Foundation.

    In December 2020, the Company completed a $75 million Series C private financing round led by existing and new investors.

    In November 2020, the Company closed a $100 million senior secured loan facility with Oxford Finance LLC. 

    In March 2020, the Company completed a $130 million Series B private financing round.

    Financial Results

    Cash and cash equivalents at December 31, 2020 totaled $177 million, before including the $287 million in net proceeds from the initial public offering and concurrent private placement in February 2021. This compared to $97 million at December 31, 2019.

    Revenue for the year ended December 31, 2020 from collaboration agreements was £30.1 million compared to £25.7 million for the year ended December 31, 2019.

    For the year ended December 31, 2020, our research and development expenses were £74.8 million compared to £100.0 million for the year ended December 31, 2019. For the year ended December 31, 2020, administrative expenses were £45.7 million, compared to £44.2 million for the year ended December 31, 2019. Our loss for the year ending December 31, 2020 was £74.1 million, compared to million £103.9 million for the year ended December 31, 2019.

    The Company anticipates that its existing cash and cash equivalents, together with the net proceeds from its initial public offering and its debt facility, is sufficient to enable the Company to fund planned operating expenses and capital expenditure requirements through at the least the end of 2022.

    ##

    About Immunocore

    Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, infectious and autoimmune. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs. Immunocore's most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies.

    Forward Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but are not limited to, statements regarding the efficacy, safety and therapeutic potential of tebentafusp, the design, progress, timing, scope and results of the Company's trials including IMCgp100-202, the anticipated timing of disclosure of results of clinical trials, plans for initiating future clinical trials and extension studies, the Company's development programs including the discovery and development of new product candidates, the potential benefit of Breakthrough Therapy Designation or Orphan Drug Designation for tebentafusp, the timing of regulatory filings including estimates regarding the planned submission a BLA for tebentafusp, the likelihood of obtaining regulatory approval of any of the Company's product candidates including tebentafusp, and the regulatory approval path for tebentafusp. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, many of which are beyond the Company's control. These risks and uncertainties include, but are not limited to, the impacts of the COVID-19 pandemic on the Company's business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; and the uncertainties and timing of the regulatory approval process. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in the Company's final prospectus dated February 4, 2021 filed with the Securities and Exchange Commission pursuant to Rule 424(b)(4) on February 8, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the Company's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information, except as required by law.

    CONTACT: 

    Immunocore

    Debra Nielsen, Head of Communications

    T: +1 (610) 368-8602

    E: debra.nielsen@immunocore.com

    Follow on Twitter: @Immunocore

    Consilium Strategic Communications (corporate and financial)

    Mary-Jane Elliott/ Chris Welsh/ Sukaina Virji

    T: +44 (0)203 709 5700

    E: Immunocore@consilium-comms.com

    Investor Relations  

    Clayton Robertson, Head of Investor Relations

    T: +1 215-384-4781

    E: ir@immunocore.com

    Immunocore Limited Annual report and consolidated financial statements

    December 31, 2020

    Consolidated Statements of Financial Position as at December 31,

        2020

    £'000
      2019

    £'000
     
    Non-current assets        
    Property, plant and equipment    13,754   18,302 
    Right of use assets    23,093   36,578 
    Investment in sub-lease    776   591 
    Other non-current financial assets    4,410   4,390 
    Deferred tax asset    2,230   1,507 
    Total non-current assets    44,263   61,368 
    Current assets          
    Trade and other receivables    10,280   9,639 
    Tax receivable    12,935   40,410 
    Embedded derivative assets    -   266 
    Cash and cash equivalents    129,716   73,966 
    Total current assets    152,931   124,281 
    Total assets    197,194   185,649 
    Equity          
    Share capital    1   - 
    Share premium    386,230   283,250 
    Foreign currency translation reserve    163   (32)
    Share-based payment reserve    18,821   10,659 
    Accumulated deficit    (349,869)  (279,106)
    Total equity    55,346   14,771 
    Non-current liabilities          
    Interest-bearing loans and borrowings    36,654   - 
    Deferred liabilities    24,868   47,961 
    Lease liabilities    25,190   38,299 
    Provisions    138   105 
    Total non-current liabilities    86,850   86,365 
    Current liabilities          
    Interest-bearing loans and borrowings    -   19,157 
    Trade and other payables    25,728   29,501 
    Deferred liabilities    27,118   28,522 
    Tax payable    -   72 
    Lease liabilities    2,043   1,951 
    Derivative liabilities    -   5,127 
    Provisions    109   183 
    Total current liabilities    54,998   84,513 
    Total liabilities    141,848   170,878 
    Total equity and liabilities    197,194   185,649 

    Immunocore Limited

    Annual report and consolidated financial statements

    December 31, 2020

     Consolidated Statements of Loss and Other Comprehensive Income

     for the years ended December 31,

        2020  2019  2018  
        £'000  £'000  £'000  
    Revenue     30,114   25,669   23,654 
    Total revenue     30,114   25,669   23,654 
                    
    Net other operating income     4,242   185   622 
    Research and development costs     (74,809)  (99,991)  (83,575)
    Administrative expenses     (45,740)  (44,183)  (34,156)
    Operating loss     (86,193)  (118,320)  (93,455)
                    
    Other income           4,979 
    Finance income     2,208   1,510   1,140 
    Finance costs     (3,375)  (9,379)  (842)
    Non-operating (expense) / income     (1,167)  (7,869)  5,277 
                    
    Loss before taxation     (87,360)  (126,189)  (88,178)
    Income tax credit     13,267   22,258   16,548 
    Loss for the year     (74,093)  (103,931)  (71,630)
                    
    Other comprehensive (expense) / income               
    Exchange differences on translation of foreign operations     195   (99)  72 
    Income tax effect relating to the components of other comprehensive income           3,634 
    Total other comprehensive (expense) / income for the year, net of tax     195   (99)  3,706 
                    
    Total comprehensive loss for the year, net of tax     (73,898)  (104,030)  (67,924)
    Basic and diluted loss per share - £     (2.79)  (4.66)  (3.32)

    Cash Flows

    The following table summarizes the primary sources and uses of cash for each period presented:

      Year ended December 31, 
     2020  2019  2018 
      $000  £000  £000  £000 
    Cash and cash equivalents at beginning of the year  101,052   73,966   124,385   82,883 
    Net cash used in operating activities  (82,756)  (60,574)  (101,376)  (16,626)
    Net cash provided by / (used in) investing activities  638   467   (4,137)  58,014 
    Net cash provided by financing activities  158,399   115,941   55,127   101 
    Foreign exchange on cash held  (115)  (84)  (33)  13 
    Cash and cash equivalents at end of the year  177,218   129,716   73,966   124,385 





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  16. OXFORDSHIRE, England and CONSHOHOCKEN, Penn. and ROCKVILLE, Md., March 10, 2021 (GLOBE NEWSWIRE) -- Immunocore (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease, today announced that four abstracts highlighting the Company's lead program, tebentafusp, were accepted at the American Association for Cancer Research (AACR) 2021 Annual Meeting, which will be held virtually from April 10-15, 2021. Two abstracts will be presented as oral presentations including, in the plenary session, Phase 3 data comparing tebentafusp (IMCgp100) with investigator's choice…

    OXFORDSHIRE, England and CONSHOHOCKEN, Penn. and ROCKVILLE, Md., March 10, 2021 (GLOBE NEWSWIRE) -- Immunocore (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease, today announced that four abstracts highlighting the Company's lead program, tebentafusp, were accepted at the American Association for Cancer Research (AACR) 2021 Annual Meeting, which will be held virtually from April 10-15, 2021. Two abstracts will be presented as oral presentations including, in the plenary session, Phase 3 data comparing tebentafusp (IMCgp100) with investigator's choice in first line metastatic uveal melanoma (mUM). A second oral presentation will feature data on the kinetics of radiographic response for tebentafusp in previously treated mUM patients. Two abstracts will be poster presentations.

    PLENARY AND ORAL PRESENTATIONS

    Title: Phase 3 randomized trial comparing tebentafusp with investigator's choice in first line metastatic uveal melanoma

    • Date and Time: Plenary session presentation (CT002), Saturday April 10th at 11:30am - 1:30pm ET
    • Presenter: Jessica C. Hassel (PI), University Hospital Heidelberg, Heidelberg, Germany
    • Abstract #: 5342
    • Session Title: Phase III Clinical Trials

    Title: Kinetics of radiographic response for tebentafusp (tebe) in previously treated metastatic uveal melanoma (mUM) patients (pts) achieving prolonged survival

    • Date and Time: Oral presentation (CT038), Monday April 12th at 1:30pm – 3:15pm ET
    • Presenter: Marcus O. Butler (PI), Princess Margaret Cancer Centre, Toronto, ON, Canada
    • Abstract #: 5338
    • Session Title: Disease-Oriented Innovative Clinical Research and Trials

    POSTER PRESENTATIONS

    Title: Uveal melanoma study patients with low CD163:CD3 ratio in tumor biopsy and low serum IL-6 showed enhanced tumor shrinkage (TS) and overall survival (OS) on tebentafusp

    • Poster #1673
    • Presenter: Jessica Hassel (PI)

    Title: Tebentafusp induces transient systemic inflammation and modifies the micro-environment to sensitize uveal melanoma tumors to cytotoxic CD8 cells

    • Poster #: 517
    • Presenter: Marcus O. Butler (PI)

    Presentations and posters will be available for registered attendees for on-demand viewing on the AACR website beginning on April 10th 2021.

    About Immunocore

    Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, infectious and autoimmune. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs. Immunocore's most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies.

    Forward Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but are not limited to, statements regarding the efficacy, safety and therapeutic potential of tebentafusp, the results, conduct, progress and timing of the Company's development programs including tebentafusp, the potential benefit of Breakthrough Therapy Designation for tebentafusp, estimates regarding the planned submission a BLA for tebentafusp and the regulatory approval path for tebentafusp. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, many of which are beyond the Company's control. These risks and uncertainties include, but are not limited to, the impacts of the COVID-19 pandemic on the Company's business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; and the uncertainties and timing of the regulatory approval process. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in in the Company's final prospectus dated February 4, 2021 filed with the Securities and Exchange Commission pursuant to Rule 424(b)(4) on February 8, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the Company's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information except as required by law. 



    CONTACT: 
    
    Immunocore
    Debra Nielsen, Head of Communications
    T: +1 (610) 368-8602
    E: debra.nielsen@immunocore.com
    Follow on Twitter: @Immunocore
    
    Consilium Strategic Communications (corporate and financial)
    Mary-Jane Elliott/ Chris Welsh/ Sukaina Virji
    T: +44 (0)203 709 5700
    E: Immunocore@consilium-comms.com
    
    Investor Relations  
    Clayton Robertson, Head of Investor Relations
    T: +1 215-384-4781
    E: ir@immunocore.com

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  17. OXFORDSHIRE, England and CONSHOHOCKEN, Pa. and ROCKVILLE, Md., Feb. 19, 2021 (GLOBE NEWSWIRE) -- Immunocore (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to tebentafusp (IMCgp100) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM).

    Bahija Jallal, Chief Executive Officer of Immunocore, said: "We are delighted that the FDA has granted Breakthrough Therapy Designation for tebentafusp

    OXFORDSHIRE, England and CONSHOHOCKEN, Pa. and ROCKVILLE, Md., Feb. 19, 2021 (GLOBE NEWSWIRE) -- Immunocore (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to tebentafusp (IMCgp100) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM).

    Bahija Jallal, Chief Executive Officer of Immunocore, said: "We are delighted that the FDA has granted Breakthrough Therapy Designation for tebentafusp based on the survival benefit from our Phase 3 clinical trial announced in November 2020. There is an urgent need for an approved treatment for this rare and aggressive form of melanoma and we look forward to continuing to work with regulators to bring tebentafusp to patients as quickly as possible."

    In an initial pre-planned interim analysis of a randomized Phase 3 clinical trial (IMCgp100-202) in previously untreated metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies, tebentafusp demonstrated superior overall survival (OS) benefit as a monotherapy. The primary endpoint was achieved when the OS Hazard Ratio (HR) in the intent-to-treat population favored tebentafusp, HR=0.51 (95% CI: 0.36, 0.71); p< 0.0001, over investigator's choice (82% pembrolizumab; 12% ipilimumab; 6% dacarbazine).

    The Breakthrough Therapy Designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

    Tebentafusp has also been granted Fast Track Designation and orphan drug designation from the FDA for uveal melanoma and Promising Innovative Medicine designation under the UK Early Access to Medicines Scheme. Immunocore will be working with the FDA to facilitate submission of a BLA for tebentafusp. If approved, Immunocore believes tebentafusp would be the first new therapy for the treatment of metastatic uveal melanoma in 40 years.

    About Immunocore

    Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, infectious and autoimmune. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs. Immunocore's most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies.

    About ImmTAC® Molecules

    Immunocore's proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilising monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognise and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognise intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an anti-CD3 immune-activating effector function. Based on the demonstrated mechanism of T cell infiltration into human tumours, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumours, regardless of mutational burden or immune infiltration, including immune "cold" low mutation rate tumours. 

    About Tebentafusp

    Tebentafusp is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. Tebentafusp specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma, and is the first molecule developed using Immunocore's ImmTAC technology platform designed to redirect and activate T cells to recognise and kill tumour cells. Tebentafusp has been granted Breakthrough Therapy Designation, Fast Track designation and orphan drug designation by the FDA in the United States and Promising Innovative Medicine (PIM) designation under the UK Early Access to Medicines Scheme for metastatic uveal melanoma. For more information about enrolling tebentafusp clinical trials for metastatic uveal melanoma, please visit ClinicalTrials.gov (NCT03070392).

    About Uveal Melanoma

    Uveal melanoma is a rare and aggressive form of melanoma, which affects the eye. Metastatic uveal melanoma typically has a poor prognosis and has no currently accepted optimal management or treatment. Although it is the most common primary intraocular malignancy in adults, the diagnosis is rare, with approximately 8,000 new patients diagnosed globally each year (1,600-2,000 cases per year in the United States). Up to 50% of people with uveal melanoma will eventually develop metastatic disease. When the cancer spreads beyond the eye, only approximately half of patients will survive for one year.

    Forward Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but are not limited to, statements regarding the efficacy, safety and therapeutic potential of tebentafusp, the results, conduct, progress and timing of the Company's development programs including tebentafusp, the potential benefit of Breakthrough Therapy Designation for tebentafusp, estimates regarding the planned submission a BLA for tebentafusp and the regulatory approval path for tebentafusp. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, many of which are beyond the Company's control. These risks and uncertainties include, but are not limited to, the impacts of the COVID-19 pandemic on the Company's business, clinical trials and financial position; unexpected safety or efficacy data observed during preclinical studies or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; changes in expected or existing competition; changes in the regulatory environment; and the uncertainties and timing of the regulatory approval process. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section titled "Risk Factors" in in the Company's final prospectus dated February 4, 2021 filed with the Securities and Exchange Commission pursuant to Rule 424(b)(4) on February 8, 2021, as well as discussions of potential risks, uncertainties, and other important factors in the Company's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information except as required by law.



    CONTACT: 
    
    Immunocore 
    Debra Nielsen, Head of Communications
    T: +1 (610) 368-8602
    E: debra.nielsen@immunocore.com 
    Follow on Twitter: @Immunocore
    
    Consilium Strategic Communications (corporate and financial)
    Mary-Jane Elliott/ Chris Welsh/ Sukaina Virji 
    T: +44 (0)203 709 5700
    E: Immunocore@consilium-comms.com
    
    Investor Relations
    Clayton Robertson, Head of Investor Relations
    T: +1 215-384-4781
    E: ir@immunocore.com

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  18. PRESS RELEASE

    Immunocore announces key appointments to management and Board

    Ralph Torbay appointed Head of Commercial to spearhead the launch of tebentafusp

    Dr. Roy S. Herbst appointed as a Non-Executive Director to the Board

    OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US – 16 February 2021 – Immunocore Holdings plc (NASDAQ:IMCR), (or the "Company" or "Immunocore"), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, today announces the appointment of Ralph Torbay as its new Head of Commercial and the appointment of Dr. Roy S. Herbst as a member…

    PRESS RELEASE

    Immunocore announces key appointments to management and Board

    Ralph Torbay appointed Head of Commercial to spearhead the launch of tebentafusp

    Dr. Roy S. Herbst appointed as a Non-Executive Director to the Board

    OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US – 16 February 2021 – Immunocore Holdings plc (NASDAQ:IMCR), (or the "Company" or "Immunocore"), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, today announces the appointment of Ralph Torbay as its new Head of Commercial and the appointment of Dr. Roy S. Herbst as a member of its Board of Directors, effective January 28, 2021. 

    Ralph Torbay is an experienced commercial leader with a proven track record of successful oncology launches and an extensive background in strategy, marketing, sales and sales management. Over the past four years, Ralph has launched three major drugs in oncology and helped to build the commercial Haematology franchise at AstraZeneca. At AstraZeneca, Ralph led the global commercial launch of IMFINZI®, the first checkpoint inhibitor therapy for stage III lung cancer, and launched Tagrisso®, which, at the time, was one of the fastest product launches and uptake in lung cancer to date. In his role as the Global Haematology Head of Marketing at AstraZeneca, Ralph was tasked with building the Haematology commercial organization while launching CALQUENCE®. Previously, Ralph led and worked on several high-profile pipeline integrations and product launches at Novartis Oncology, including GLEEVEC®, TASIGNA®, ARZERRA® and FARYDAK®. Ralph received his Master of Business Administration from Simon Graduate School of Business, University of Rochester, Rochester, NY and his Bachelor of Science in Biotechnology from Rochester Institute of Technology, Rochester, NY. Ralph will be developing and implementing Immunocore's commercial strategy. He will be based in Immunocore's Rockville, Maryland office.

    Roy Herbst joined the Immunocore Board of Directors in January. He previously served as a member of Immunocore's Scientific Advisory Board (SAB) and is internationally recognized for his leadership and expertise as a physician-scientist in lung cancer treatment and research. He is currently Ensign Professor of Medicine (Medical Oncology), Professor of Pharmacology, Chief of Medical Oncology and Associate Cancer Center Director for Translational Research at Yale Cancer Center and Smilow Cancer Hospital. In 2020, Roy was awarded the Distinguished Public Service Award for Exceptional Leadership in Cancer Science Policy by the American Association for Cancer Research. He is also a member of the Board of Directors of the American Association for Cancer Research, the International Association for the Study of Lung Cancer and Shanghai Junshi Biosciences Co., Ltd., and is a member of the Thoracic Malignancy Steering Committee at the National Cancer Institute.

    Bahija Jallal, Chief Executive Officer of Immunocore, said: "Ralph brings a wealth of industry experience to Immunocore with a proven track record in global commercial success through the launch of several high-profile products. His expertise will be instrumental as we prepare for the commercial launch of tebentafusp, our lead ImmTAC product candidate for the treatment of patients with metastatic uveal melanoma.

    "I would also like to welcome Roy to Immunocore's Board of Directors. Roy is an expert in the field and has been a trusted advisor to the Company for many years. I am delighted to have him join our Board where we believe his extensive scientific background and expertise in cancer treatment and research will be invaluable as we implement our strategy."

    Ralph Torbay, Head of Commercial at Immunocore, said: "The impressive quality of data already published for tebentafusp clearly demonstrates its potential as a new breakthrough treatment for metastatic uveal melanoma patients, an underserved group where new therapies are urgently needed. This is a testament to the excellence of Immunocore's pioneering science and underlines the potential of our bispecific immunotherapies across a range of indications. I am very much looking forward to being part of the team advancing tebentafusp and other future potential Immunocore products with the aim of transforming patients' lives."

    Dr. Roy S. Herbst, Non-Executive Director of Immunocore, said: "It has been my pleasure to work on Immunocore's SAB over the past few years and I am pleased to have this opportunity to work even more closely with the team at Board level as we reach a critical and exciting stage in the Company's development."

    - Ends -

    About Immunocore

    Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, infectious and autoimmune. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs. Immunocore's most advanced oncology therapeutic candidate, tebentafusp, has demonstrated monotherapy activity in a Phase 2 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies, and is currently being studied in an ongoing Phase 3 clinical trial.

    For more information, please contact:

    Immunocore

    Debra Nielsen, Head of Communications

    T: +1 (610) 368-8602

    E: debra.nielsen@immunocore.com

    Follow on Twitter: @Immunocore

    Consilium Strategic Communications (corporate and financial)

    Mary-Jane Elliott/ Chris Welsh/ Sukaina Virji

    T: +44 (0)203 709 5700

    E: Immunocore@consilium-comms.com

    Investor Relations  

    Clayton Robertson, Head of Investor Relations

    T: +1 215-384-4781

    E: ir@immunocore.com



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  19. PRESS RELEASE

    Immunocore Announces Closing of $312.1 Million Aggregate Financing, Consisting of $297.1 Million Initial Public Offering, Full Exercise of Option to Purchase Additional ADSs and $15.0 Million Concurrent Private Placement

    OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US – 9 February 2021 – Immunocore Holdings plc (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, today announced the closing of its previously announced initial public offering in the United States of 11,426,280 American Depositary Shares ("ADSs") representing…

    PRESS RELEASE

    Immunocore Announces Closing of $312.1 Million Aggregate Financing, Consisting of $297.1 Million Initial Public Offering, Full Exercise of Option to Purchase Additional ADSs and $15.0 Million Concurrent Private Placement

    OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US – 9 February 2021 – Immunocore Holdings plc (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, today announced the closing of its previously announced initial public offering in the United States of 11,426,280 American Depositary Shares ("ADSs") representing 11,426,280 ordinary shares, including the exercise in full by the underwriters of their option to purchase an additional 1,490,384 ADSs, at an initial public offering price of $26.00 per ADS. The gross proceeds to Immunocore from the offering were approximately $297.1 million. All ADSs sold in the offering were offered by Immunocore.

    Goldman Sachs & Co. LLC, J.P. Morgan Securities LLC and Jefferies LLC acted as joint book-running managers for the offering.

    In addition to the ADSs sold in the public offering, Immunocore announced the completion of the concurrent sale of an additional 576,923 ADSs at the initial offering price of $26.00 per ADS, for gross proceeds of approximately $15.0 million, in a private placement to the Bill & Melinda Gates Foundation. The sale of these ADSs was not registered under the Securities Act of 1933, as amended, and the ADSs are subject to a 180-day lock-up agreement. 

    A registration statement relating to these securities became effective on February 4, 2021. The offering was made only by means of a prospectus. Copies of the final prospectus related to the offering may be obtained from any of the joint book-running managers for the offering:  Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, New York 10282, telephone: 866-471-2526, facsimile: 212-902-9316, e-mail: prospectus-ny@ny.email.gs.com; J.P. Morgan Securities LLC,  c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at +1 866 803 9204 or by email at prospectus-eq_fi@jpmchase.com; or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at +1 877 821 7388 or by email at Prospectus_Department@Jefferies.com. For the avoidance of doubt, such prospectus will not constitute a "prospectus" for the purposes of the Regulation (EU) 2017/1129 and has not been reviewed by any competent authority in any member state in the European Economic Area or the United Kingdom.

    A registration statement relating to these securities has been filed with, and declared effective by, the U.S. Securities and Exchange Commission (the "SEC"). Copies of the registration statement can be accessed through the SEC's website at www.sec.gov. This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

    In any member state of the European Economic Area (the "EEA") this announcement and any offering are only addressed to and directed at persons who are "qualified investors" ("Qualified Investors") within the meaning of the Prospectus Regulation (Regulation (EU) 2017/1129). In the United Kingdom, this announcement and any offering are only addressed to and directed at persons who are "qualified investors" within the meaning of the UK Prospectus Regulation (Regulation (EU) 2017/1129 as if forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018) (i) who have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "Order"), (ii) high net worth entities who fall within Article 49(2)(a) to (d) of the Order, or (iii) to whom it may otherwise lawfully be communicated (all such persons being referred to as "relevant persons").

    This announcement must not be acted on or relied on (i) in the United Kingdom, by persons who are not relevant persons, and (ii) in any member state of the EEA, by persons who are not Qualified Investors. Any investment or investment activity to which this announcement relates is available only to and will only be engaged with (i) in the United Kingdom, relevant persons, and (ii) in any member state of the EEA, Qualified Investors.

    About Immunocore

    Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, infectious and autoimmune. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs. Immunocore's most advanced oncology therapeutic candidate, tebentafusp, has demonstrated monotherapy activity in a Phase 2 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies, and is currently being studied in an ongoing Phase 3 clinical trial.

    ##

    Contacts:

    Immunocore

    Media

    Debra Nielsen, Head of Communications

    T: +1 (610) 368-8602

    E: debra.nielsen@immunocore.com

    Consilium Strategic Communications (corporate and financial)

    Mary-Jane Elliott/ Chris Welsh/ Sukaina Virji

    T: +44 (0)203 709 5700

    E: Immunocore@consilium-comms.com

    Investor Relations  

    E: ir@immunocore.com



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  20. PRESS RELEASE

    Immunocore Announces Pricing of Upsized Initial Public Offering

    OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US – 4 February 2021 – Immunocore Holdings plc (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, today announced the pricing of its upsized initial public offering in the United States of 9,935,896 American Depositary Shares ("ADSs") representing 9,935,896 ordinary shares at an initial public offering price of $26.00 per ADS, for total gross proceeds of approximately $258.3 million. All ADSs sold in the offering…

    PRESS RELEASE

    Immunocore Announces Pricing of Upsized Initial Public Offering

    OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US – 4 February 2021 – Immunocore Holdings plc (NASDAQ:IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, today announced the pricing of its upsized initial public offering in the United States of 9,935,896 American Depositary Shares ("ADSs") representing 9,935,896 ordinary shares at an initial public offering price of $26.00 per ADS, for total gross proceeds of approximately $258.3 million. All ADSs sold in the offering were offered by Immunocore. The ADSs are expected to begin trading on The Nasdaq Global Select Market on February 5, 2021 under the ticker symbol "IMCR." In addition, Immunocore has granted the underwriters a 30-day option to purchase up to an additional 1,490,384 ADSs at the initial public offering price, less underwriting discounts and commissions. The offering is expected to close on or about February 9, 2021, subject to customary closing conditions.

    Goldman Sachs & Co. LLC, J.P. Morgan Securities LLC and Jefferies LLC are acting as joint book-running managers for the offering.

    A registration statement relating to these securities became effective on February 4, 2021. The offering will be made only by means of a prospectus. When available, copies of the final prospectus related to the offering can be obtained from any of the joint book-running managers for the offering:  Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, New York 10282, telephone: 866-471-2526, facsimile: 212-902-9316, e-mail: prospectus-ny@ny.email.gs.com; J.P. Morgan Securities LLC,  c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at +1 866 803 9204 or by email at prospectus-eq_fi@jpmchase.com; or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at +1 877 821 7388 or by email at Prospectus_Department@Jefferies.com. For the avoidance of doubt, such prospectus will not constitute a "prospectus" for the purposes of the Regulation (EU) 2017/1129 and has not been reviewed by any competent authority in any member state in the European Economic Area or the United Kingdom.

    A registration statement relating to these securities has been filed with, and declared effective by, the U.S. Securities and Exchange Commission (the "SEC"). Copies of the registration statement can be accessed through the SEC's website at www.sec.gov. This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

    In any member state of the European Economic Area (the "EEA") this announcement and any offering are only addressed to and directed at persons who are "qualified investors" ("Qualified Investors") within the meaning of the Prospectus Regulation (Regulation (EU) 2017/1129). In the United Kingdom, this announcement and any offering are only addressed to and directed at persons who are "qualified investors" within the meaning of the UK Prospectus Regulation (Regulation (EU) 2017/1129 as if forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018) (i) who have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "Order"), (ii) high net worth entities who fall within Article 49(2)(a) to (d) of the Order, or (iii) to whom it may otherwise lawfully be communicated (all such persons being referred to as "relevant persons").

    This announcement must not be acted on or relied on (i) in the United Kingdom, by persons who are not relevant persons, and (ii) in any member state of the EEA, by persons who are not Qualified Investors. Any investment or investment activity to which this announcement relates is available only to and will only be engaged with (i) in the United Kingdom, relevant persons, and (ii) in any member state of the EEA, Qualified Investors.

    About Immunocore

    Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, infectious and autoimmune. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs. Immunocore's most advanced oncology therapeutic candidate, tebentafusp, has demonstrated monotherapy activity in a Phase 2 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies, and is currently being studied in an ongoing Phase 3 clinical trial.

    Forward-Looking Statements

    This press release contains certain forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including statements with regard to Immunocore' expectations regarding the commencement of trading of ADSs on The Nasdaq Global Select Market and the completion of the proposed securities offering. Words such as "anticipates," "believes," "expects," "intends," "projects," "anticipates," and "future" or similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to the inherent uncertainties in predicting future results and conditions and no assurance can be given that the proposed securities offering discussed above will be consummated on the terms described or at all. Completion of the proposed offering and the terms thereof are subject to numerous factors, many of which are beyond the control of Immunocore, including, without limitation, market conditions, failure of customary closing conditions and the risk factors and other matters set forth in Immunocore's filings with the SEC. Immunocore undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

    ##

    Contacts:

    Immunocore

    Media

    Debra Nielsen, Head of Communications

    T: +1 (610) 368-8602

    E: debra.nielsen@immunocore.com

    Consilium Strategic Communications (corporate and financial)

    Mary-Jane Elliott/ Chris Welsh/ Sukaina Virji

    T: +44 (0)203 709 5700

    E: Immunocore@consilium-comms.com

    Investor Relations  

    E: ir@immunocore.com



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