IMCR Immunocore Holdings plc

35.96
+0.82  (+2%)
Previous Close 35.14
Open 34.95
52 Week Low 27.77
52 Week High 61.9899
Market Cap $1,574,547,724
Shares 43,786,088
Float 43,786,088
Enterprise Value $1,202,350,521
Volume 57,759
Av. Daily Volume 77,083
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Drug Stage Catalyst Date
IMC-C103C - MAGE-A4
Solid tumors
Phase 1
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Tebentafusp
Uveal melanoma
PDUFA
PDUFA
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IMC-F106C (PRAME)
Solid tumors
Phase 1
Phase 1
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GSK01
Synovial sarcoma
Phase 1
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Latest News

  1. 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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  2. 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



    Primary Logo

    View Full Article Hide Full Article
  3. 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…

    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



    Primary Logo

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  4. 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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  5. 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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