IMCR Immunocore Holdings plc

19.83
+0.89  (+5%)
Previous Close 18.94
Open 18.87
52 Week Low 18.76
52 Week High 61.9899
Market Cap $869,385,492
Shares 43,841,931
Float 43,841,931
Enterprise Value $608,530,586
Volume 293,088
Av. Daily Volume 90,720
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Upcoming Catalysts

Drug Stage Catalyst Date
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
Phase 1
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Drug Pipeline

Drug Stage Notes
IMC-C103C - MAGE-A4
Solid tumors
Phase 1
Phase 1
Phase 1 initial data demonstrated manageable safety profile, biomarkers of T cell activation consistent and robust at doses ≥ 90 micrograms. Clinical activity with confirmed durable responses, noted December 6, 2021.

Latest News

  1. Immunocore to present at the 40th Annual J.P. Morgan Healthcare Conference

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 6 January 2022) 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 management will participate in the virtual 40th Annual J.P. Morgan Healthcare Conference.

    The presentation is scheduled for Wednesday, January 12, 2022 at 7:30 a.m. Eastern Time (ET).

    The presentation and Q&A session will be webcast live during the conference and will be available in the ‘Investors' section…

    Immunocore to present at the 40th Annual J.P. Morgan Healthcare Conference

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 6 January 2022) 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 management will participate in the virtual 40th Annual J.P. Morgan Healthcare Conference.

    The presentation is scheduled for Wednesday, January 12, 2022 at 7:30 a.m. Eastern Time (ET).

    The presentation and Q&A session will be webcast live during the conference and will be available in the ‘Investors' section of Immunocore's website at www.immunocore.com. A replay of the presentation and Q&A session 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 Company's business strategy including the design, progress, timing, scope and results of the Company's clinical trials including IMC-C103C and 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; 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:

    Follow on Twitter: @Immunocore

    Consilium Strategic Communications (corporate and financial)

    Mary-Jane Elliott/ Chris Welsh/Jessica Hodgson

    T: +44 (0)203 709 5700

    E:

    Investor Relations  

    Clayton Robertson, Head of Investor Relations

    T: +1 215-384-4781

    E:



    Primary Logo

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  2.         

    Immunocore announces initial Phase 1 data of ImmTAC® candidate IMC-C103C targeting MAGE-A4

    Clinical activity with confirmed durable responses in ovarian cancer and a confirmed durable response in HNSCC

    Manageable safety profile

    Biomarkers of T cell activation consistent and robust at doses 90 micrograms

    First expansion in high grade serous ovarian cancer initiated
            
    Immunocore to host a webcast today at 8:00 am E.T.

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 6 December 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…

            

    Immunocore announces initial Phase 1 data of ImmTAC® candidate IMC-C103C targeting MAGE-A4

    Clinical activity with confirmed durable responses in ovarian cancer and a confirmed durable response in HNSCC

    Manageable safety profile

    Biomarkers of T cell activation consistent and robust at doses 90 micrograms

    First expansion in high grade serous ovarian cancer initiated

            

    Immunocore to host a webcast today at 8:00 am E.T.

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 6 December 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 the initial Phase 1 data of IMC-C103C, a bispecific T cell engager targeting MAGE-A4, in selected advanced solid tumors.

    IMC-C103C was developed using the company's innovative ImmTAC® technology platform and is being developed in partnership with Genentech, a member of the Roche Group. The trial (IMC-C103C-101) includes a Phase 1 dose escalation to evaluate safety, maximum tolerated dose / expansion dose, and preliminary clinical activity. The initial Phase 1 data from this study is the subject of a presentation at the European Society of Medical Oncology Immuno-Oncology Congress.

    The presentation includes data from 44 patients enrolled across 10 dose-escalation cohorts. Indications with high MAGE-A4 prevalence (eg. serous ovarian, synovial sarcoma) enrolled all-comers with retrospective MAGE-A4 testing by immunohistochemistry (IHC) while other indications required prospective confirmation of tumor MAGE-A4 expression by IHC.

    IMC-C103C demonstrated a manageable safety profile. The most common any-grade, treatment-related adverse events were consistent with cytokine release syndrome, were dose dependent and rapidly resolved. The most common related grade 3 or grade 4 adverse event was neutropenia, typically at doses ≥ 90 micrograms. Neutropenia was reversible, with treatment interruption or G-CSF, and was not dose-limiting. None of the treatment-related AEs led to discontinuation or death.

    IMC-C103C dose escalation began at 0.5 micrograms, the minimum anticipated biological effect level (MABEL), and includes 10 cohorts to date. Pharmacodynamic biomarkers of T cell activation were first observed at 15 micrograms and became consistent and robust at doses ≥ 90 micrograms. IMC-C103C treatment results in a substantial increase in T cell infiltration in tumor biopsies relative to baseline.

    The most frequently enrolled patients had platinum relapsed/refractory ovarian cancer, who were enrolled regardless of their tumor MAGE-A4 protein expression. Most of these patients had low or no MAGE-A4 protein expression in their tumors as measured by IHC (median H score = 8). One ovarian cancer patient, with a very low MAGE protein expression, treated at a dose of < 90 micrograms, had a durable confirmed partial response (PR) with 8.3 months duration. An additional ovarian cancer patient at a dose of ≥ 90 micrograms, also with very low MAGE-A4 protein expression, has a confirmed partial response ongoing at 4.4+ months. One of the three non-ovarian cancer patients (head and neck squamous cell carcinoma) at a dose of ≥ 90 micrograms has a confirmed PR that is ongoing.

    "IMC-C103C is our second T cell engager to demonstrate durable clinical activity, now in multiple solid tumors," stated Bahija Jallal, Chief Executive Officer. "We are highly encouraged to see these responses in ovarian and head and neck cancer. The durable PRs in ovarian cancer occur in heavily pre-treated patients even with low MAGE-A4 protein tumor expression. We have initiated an expansion arm in ovarian carcinoma, while we continue signal searching and determining the optimal dose in multiple solid tumors."

    Earlier this month, Immunocore initiated an expansion arm in high grade serous ovarian carcinoma at 140 micrograms. IMC-C103C-101 will continue to explore the optimal dose and evaluate clinical activity in multiple solid tumors. The company plans to present additional data from this program in 2022. IMC-C103C is part of a co-development / co-promotion collaboration with Genentech under which Immunocore shares program costs and profits equally.

    Conference Call Information

    Immunocore will host a live webcast and conference call today beginning at 8:00 am E.T. to discuss the results with Dr. Diwakar Davar, an assistant professor of medicine and a medical oncologist and hematologist at the University of Pittsburgh Medical Center (UPMC). A live webcast of the conference call will be available under "Events" in the Investor Relations section of Immunocore Holdings' website at www.immunocore.com. The presentation from today's call and the archived webcast will be available on Immunocore's website after the conference call concludes and will be available for 30 days following the call.

    ##

    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 the design, progress, timing, scope and results of the Company's clinical trials including IMC-C103C and 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; 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:

    Follow on Twitter: @Immunocore

    Consilium Strategic Communications (corporate and financial)

    Mary-Jane Elliott/ Chris Welsh/ Jessica Hodgson

    T: +44 (0)203 709 5700

    E:

    Investor Relations  

    Clayton Robertson, Head of Investor Relations

    T: +1 215-384-4781

    E:



    Primary Logo

    View Full Article Hide Full Article
  3. PRESS RELEASE

    Immunocore to present at the Jefferies London Healthcare Conference

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 11 November 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 that management will participate in a fireside chat at the Jefferies London Healthcare Conference, taking place November 16-19, 2021.

    The presentation will be available on-demand for attendees during the virtual conference beginning on November 18, 2021. The webcast can also be accessed in the ‘Investors' section…

    PRESS RELEASE

    Immunocore to present at the Jefferies London Healthcare Conference

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 11 November 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 that management will participate in a fireside chat at the Jefferies London Healthcare Conference, taking place November 16-19, 2021.

    The presentation will be available on-demand for attendees during the virtual conference beginning on November 18, 2021. The webcast can also be accessed in the ‘Investors' section of Immunocore's website at www.immunocore.com.

    ##

    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 expected timing of a BLA review and action date 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, IMC-I109V and IMC-M113V, 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:

    Follow on Twitter: @Immunocore

    Consilium Strategic Communications (corporate and financial)

    Mary-Jane Elliott/ Chris Welsh/Jessica Hodgson

    T: +44 (0)203 709 5700

    E:

    Investor Relations  

    Clayton Robertson, Head of Investor Relations

    T: +1 215-384-4781

    E:



    Primary Logo

    View Full Article Hide Full Article
  4. PRESS RELEASE

    Immunocore Reports Third Quarter 2021 Financial Results
    and Provides Business Update

    Biologics License Application (BLA) and Marketing Authorisation Application (MAA) submissions accepted for tebentafusp in metastatic uveal melanoma; FDA set a PDUFA date of February 23, 2022

    Over 150 patients have accessed tebentafusp through the global early access program across 14 countries
            
    Dose escalation of IMC-C103C targeting MAGE-A4 continues as planned; investor call planned for initial Phase 1 MAGE-A4 data scheduled for presentation at the ESMO IO Congress in December

    Cash position of approximately $346 million as of September 30, 2021

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 10 November 2021) Immunocore

    PRESS RELEASE

    Immunocore Reports Third Quarter 2021 Financial Results

    and Provides Business Update

    Biologics License Application (BLA) and Marketing Authorisation Application (MAA) submissions accepted for tebentafusp in metastatic uveal melanoma; FDA set a PDUFA date of February 23, 2022

    Over 150 patients have accessed tebentafusp through the global early access program across 14 countries

            

    Dose escalation of IMC-C103C targeting MAGE-A4 continues as planned; investor call planned for initial Phase 1 MAGE-A4 data scheduled for presentation at the ESMO IO Congress in December

    Cash position of approximately $346 million as of September 30, 2021

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 10 November 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 nine months ended September 30, 2021 and provides a business update.

    Immunocore's recent and third quarter highlights include the acceptance of tebentafusp regulatory submissions in the US, EU and UK; the publication of Phase 3 tebentafusp data in the New England Journal Medicine; and the continued dose escalation of MAGE-A4 and PRAME targeting ImmTACs® with data to be presented from IMC-C103C targeting MAGE-A4 at the European Society of Medical Oncology Immuno-Oncology Congress in December of this year (ESMO IO Congress).

    Bahija Jallal, Chief Executive Officer of Immunocore, said: "We continue to be encouraged by the interest in our tebentafusp data in metastatic uveal melanoma, including the publication of our Phase 3 data in the New England Journal of Medicine. We have now activated our early access program in fourteen countries and have treated over 150 patients with metastatic uveal melanoma over the last six months. As we advance our ImmTAC programs in other solid tumors, we look forward to continuing to update on our progress at upcoming medical meetings."

    Third Quarter 2021 Highlights (including post-period)

    Tebentafusp

    Earlier this month, the Company presented new clinical data from the metastatic uveal melanoma (mUM) tebentafusp monotherapy program and a Phase 1b study of tebentafusp in combination with durvalumab (anti-PDL1) and/or tremelimumab (anti-CTLA4) in metastatic cutaneous melanoma (mCM) in poster presentations at the Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting. In a phase 1b trial in mCM of tebentafusp in combination with checkpoint inhibitors, in which the majority of patients had previously received prior anti-PD(L)1 treatments, the maximum target doses of tebentafusp (68 mcg) plus durvalumab (20 mg/kg) with and with/out tremelimumab (1 mg/kg) were tolerated in both doublet and triplet arms of the study. Preliminary evidence of tebentafusp clinical activity in mCM patients who had prior anti-PD(L)1 therapy, currently an unmet medical need, included 1-year overall survival (OS) rate of 76%. In mCM patients who were refractory (defined as best response of progressive disease) to prior anti-PD(L)1, the 1-year OS rate was 61%. In addition, the Company presented a new analysis of baseline gp100 protein tumor expression by immunohistochemistry of tumor biopsies from the phase 2 and phase 3 tebentafusp monotherapy mUM trials, where OS benefit was observed for both high and low gp100 protein tumor expression. Four additional posters depicting new analyses from tebentafusp in metastatic uveal melanoma, as well as the Company's proprietary soluble TCR bispecific ImmTAC platform were also accepted for presentation at the upcoming SITC 36th Annual Meeting and will be made available for on-demand viewing throughout the meeting.

    In October, the Company announced an exclusive multi-regional agreement for Medison Pharma Ltd. to help seek regulatory authorization and commercialize Immunocore's tebentafusp (IMCgp100), for the treatment of patients with mUM, in Canada, twenty markets across Central Eastern Europe and Israel. Under the agreement, Medison Pharma would also provide assistance with commercialization activities, assuming regulatory approval is received.

    In the third quarter, the Australian Government Department of Health granted tebentafusp Orphan Drug Designation. Additionally, the Australian Government Department of Health has accepted the Marketing Application for tebentafusp in mUM, and the company (through the Adjutor Healthcare Party Ltd.) has also received a Priority Review of its application for approval.

    In September, The New England Journal of Medicine (NEJM) published online data from the IMCgp100-202 Phase 3 randomized clinical trial in mUM where the OS Hazard Ratio (HR) in the intent-to-treat population favored tebentafusp, HR=0.51 (95% CI: 0.37, 0.71). The NEJM paper concluded that tebentafusp prolonged OS compared to investigator's choice in previously untreated mUM.

    In September, the Company presented new data and analysis from tebentafusp at the ESMO Congress. The findings presented in an oral presentation, by Alexander N. Shoushtari MD, medical oncologist at Memorial Sloan Kettering Cancer Center, demonstrated that 70% of evaluable patients had a reduction in circulating tumor DNA (ctDNA) by Week 9 and the degree of reduction was strongly associated with OS.

    In September, the Company announced the United Kingdom's Medicines and Healthcare products Regulatory Agency has accepted a MAA seeking the approval of tebentafusp for the treatment of patients with mUM.

    In August, the U.S. Food and Drug Administration (FDA) accepted for review Immunocore's BLA for tebentafusp. 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, there is a PDUFA target action date of February 23, 2022.

    The FDA will review the BLA for tebentafusp 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 granted Breakthrough Therapy Designation to tebentafusp for the treatment of HLA-A*02:01-positive adult patients with unresectable or mUM. Over 150 patients have accessed tebentafusp through the global early access program across 14 countries.

    In August, the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP), accepted the Company's MAA. In July, the EMA 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 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).

    IMC-C103C targeting MAGE-A4

    In the third 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, and ovarian. 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 the initial Phase 1 data at the ESMO IO Congress in December. Immunocore will also host an investor call on December 6th that will be accessible via the ‘Investor Relations' section of the Company's website.

    IMC-F106C targeting PRAME

    In the third 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 the initial Phase 1 data in mid-2022.

    IMC-I109V targeting HBV

    In the third quarter, the Company continued to enroll patients in the IMC-I109V global Phase 1 single ascending dose trial. IMC-I109V is the first candidate in development using the Company'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.

    IMC-M113V targeting HIV

    In the third quarter, the Company continued to advance IMC-M113V, an ImmTAV molecule target an HIV gag antigen bispecific TCR molecule. 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.

    Financial Results

    Basic and diluted loss per share was £0.69 or $0.93 for the three months ended September 30, 2021 compared to an adjusted £0.72 for the three months ended September 30, 2020. Basic and diluted loss per share was £2.19 or $2.95 for the nine months ended September 30, 2021 compared to an adjusted £2.02 for the nine months ended September 30, 2020. Total operating loss for the three months ended September 30, 2021 was £31.0 million or $41.7 million compared to £23.4 million for the same period last year. Total operating loss for the nine months ended September 30, 2021 was £97.3 million or $131.1 million compared to £66.0 million for the same period in the prior year. The increases in operating loss were driven by increases in employee costs associated with a non-cash share-based payment charge.

    Revenue for the three and nine months ended September 30, 2021 was £5.9 million or $8.0 million and £19.9 million or $26.8 million, respectively, as compared to £6.7 million and £22.7 million, respectively, for the three and nine months ended September 30, 2020. The decrease in revenue was primarily due to a reduction in activity under our collaboration agreements.

    For the three and nine months ended September 30, 2021, our research and development ("R&D") expenses were £16.8 million or $22.6 million and £53.2 million or $71.6 million, respectively, as compared to £20.4 million and £57.6 million, respectively, for the three and nine months ended September 30, 2020. The reduction in R&D expenses was largely attributable to a reduction in clinical trial activity for tebentafusp as we seek regulatory approval and prepare for commercial launch.

    For the three and nine months ended September 30, 2021, our administrative expenses were £20.0 million or $27.0 million and £64.0 million or $86.3 million, respectively, compared to £9.7 million and £31.6 million respectively, for the three and nine months ended September 30, 2020. The overall increase was driven by a £6.4 million and £19.3 million increase, respectively, in the non-cash share-based payment charge. In addition, pre-commercial expenditure relating to tebentafusp increased by £4.8 million and £10.4 million, respectively, in the three and nine months ended September 30, 2021.

    Cash and cash equivalents were £256.6 million or approximately $345.6 million as of September 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 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. 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 in 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 expected timing of a BLA review and action date 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, IMC-I109V and IMC-M113V, 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:

    Follow on Twitter: @Immunocore

    Consilium Strategic Communications (corporate and financial)

    Mary-Jane Elliott/ Chris Welsh/ Jessica Hodgson

    T: +44 (0)203 709 5700

    E:

    Investor Relations  

    Clayton Robertson, Head of Investor Relations

    T: +1 215-384-4781

    E:

    Consolidated Statement of Loss

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

     Three Months Ended September 30,
     20212020
     $'000£'000£'000
    Revenue7,980  5,924  6,652
    Research and development expenses (22,627)  (16,798)  (20,409)
    Administrative expenses (27,005)  (20,048)  (9,714)
    Net other operating (loss) income (38)  (28)  52
    Operating loss (41,690)  (30,950)  (23,419)
    Finance income 11  8  367
    Finance costs (1,774)  (1,317)  (570)
    Non-operating expense (1,763)  (1,309)  (203)
    Loss before taxes (43,453)  (32,259)  (23,622)
    Income tax credit 2,862  2,125  4,265
    Loss for the period (40,591)  (30,134)  (19,357)

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

     Nine Months Ended September 30,
     20212020
     $'000£'000£'000
    Revenue26,842  19,927  22,694
    Research and development expenses (71,598)  (53,154)  (57,566)
    Administrative expenses (86,252)  (64,033)  (31,569)
    Net other operating (expense) / income (94)  (70)  408
    Operating loss (131,102)  (97,330)  (66,033)
    Finance income 57  42  1,972
    Finance costs (6,014)  (4,465)  (2,272)
    Non-operating expense (5,957)  (4,423)  (300)
    Loss before taxes (137,059)  (101,753)  (66,333)
    Income tax credit 12,957  9,619  11,120
    Loss for the period (124,102)  (92,134)  (55,213)

    Condensed Consolidated Statement of Cash Flows for Each Period Presented:

     Nine Months Ended September 30,
     202120212020
     $'000£'000£'000
       (unaudited) 
    Cash and cash equivalents at beginning of year 174,727  129,716  73,966
    Net cash flows used in operating activities(107,461)  (79,778)  (40,674)
    Net cash flows used in investing activities(137)  (102)  (670)
    Net cash flows from financing activities278,413  206,691  23,978
    Net foreign exchange difference on cash held32  24  87
    Cash and cash equivalents at end of period345,574  256,551  56,687

    Consolidated Statements of Financial Position for Each Period Presented:

      September 30,



    2021



    £'000
    December 31,



    2020



    £'000
    Non-current assets   
    Property, plant and equipment 10,04313,754
    Right of use assets     22,772  23,093
    Investment in sub-lease 188776
    Other non-current financial assets    5,6094,410
    Deferred tax asset 2,2572,230
    Total non-current assets 40,86944,263
    Current assets   
    Trade and other receivables  10,76510,280
    Tax receivable  22,55512,935
    Cash and cash equivalents  256,551129,716
    Total current assets  289,871152,931
    Total assets  330,740197,194
    Equity   
    Share capital  8864
    Share premium  211,930​-
    Foreign currency translation reserve  71163
    Other reserves     386,167  386,167
    Share-based payment reserve  45,63418,821
    Accumulated deficit  (442,003)​)(349,869)
    Total equity  201,88755,346
    Non-current liabilities   
    Interest-bearing loans and borrowings     37,280  36,654
    Deferred revenue 10,68124,868
    Lease liabilities 25,48625,190
    Provisions 81138
    Total non-current liabilities  73,52886,850
    Current liabilities   
    Interest-bearing loans and borrowings 546
    Trade and other payables 28,81525,728
    Deferred revenue 24,45027,118
    Lease liabilities 1,3692,043
    Provisions 145109
    Total current liabilities 55,32554,998
    Total liabilities 128,853141,848
    Total equity and liabilities 330,740197,194



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  5. PRESS RELEASE RESS RELEASE

    Immunocore presents new data on tebentafusp in metastatic cutaneous melanoma (mCM) and uveal melanoma (mUM) at the Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting

    Tebentafusp in combination with checkpoint inhibitors had acceptable safety profile; preliminary evidence of clinical activity in anti-PD(L)1 relapsed/refractory mCM

    Survival benefit for tebentafusp monotherapy in mUM observed for both high and low gp100 protein tumor expression

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 9 November 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…

    PRESS RELEASE RESS RELEASE

    Immunocore presents new data on tebentafusp in metastatic cutaneous melanoma (mCM) and uveal melanoma (mUM) at the Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting

    Tebentafusp in combination with checkpoint inhibitors had acceptable safety profile; preliminary evidence of clinical activity in anti-PD(L)1 relapsed/refractory mCM

    Survival benefit for tebentafusp monotherapy in mUM observed for both high and low gp100 protein tumor expression

    (OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 9 November 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, will present six posters at the Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting, to be held in Washington, D.C. and virtually between November 10-14th.

    The Company will present a Phase 1b study of tebentafusp in combination with durvalumab (anti-PDL1) and/or tremelimumab (anti-CTLA4) in metastatic cutaneous melanoma (mCM) and new clinical data analyzing gene expression and overall survival from the metastatic uveal melanoma (mUM) tebentafusp monotherapy program. Four additional posters depicting new analyses from tebentafusp in metastatic uveal melanoma, as well as the Company's proprietary soluble TCR bispecific ImmTAC® platform will be made available for on-demand viewing throughout the SITC 36th Annual Meeting on the SITC website.

    In a phase 1b trial in mCM of tebentafusp in combination with checkpoint inhibitors, in which the majority of patients had previously received prior anti-PD(L)1 therapy, the maximum target doses of tebentafusp (68 mcg) plus durvalumab (20 mg/kg) with and with/out tremelimumab (1 mg/kg) were tolerated in both doublet and triplet arms of the study. Preliminary evidence of tebentafusp clinical activity in mCM patients who received prior anti-PD(L)1 therapy, currently an unmet medical need, included 1-year overall survival (OS) rate of 76%. In mCM patients who were refractory (defined as best response of progressive disease) to prior anti-PD(L)1, the 1-year OS rate was 61%.

    "At SITC, we build upon our previously released survival data in metastatic uveal melanoma with the clinical results of tebentafusp in combination with checkpoint inhibitors in metastatic cutaneous melanoma patients who previously received anti-PD(L)1 therapy. In this population with poor prognosis, and which is an unmet need, treatment with tebentafusp in combination with checkpoints resulted in a 76% one-year overall survival rate" said David Berman, Head of Research and Development at Immunocore.

    In a new analysis of baseline gp100 protein expression by immunohistochemistry of tumor biopsies from the Phase 2 and Phase 3 tebentafusp monotherapy mUM trials, OS benefit was observed for both high and low gp100 protein tumor expression. Additionally, circulating tumor DNA (ctDNA) reductions were also observed for both high and low gp100 protein tumor expression, while high gp100 expression at baseline was associated with greater T cell infiltration into the tumor and greater IFNg, granzyme B and perforin expression.

    "We are encouraged that the survival benefit from tebentafusp in metastatic uveal melanoma was independent of baseline gp100 tumor expression in this new analysis based on immunohistochemistry. This benefit, apparent even in patients with low gp100 protein expression, may reflect the high sensitivity of our TCR bispecific platform, which may be able to recognize cancer cells with very low target expression" said David Berman.

    POSTER PRESENTATIONS

    Title: Overall survival on tebentafusp in metastatic uveal melanoma (mUM) across the range of tumor gp100 expression levels  

    • Poster #: 868
    • Author: Emma Leach
    • Location: Poster Hall (Hall E)
    • Date & Time: November 13th - 12:30-2:00 pm and 7:00-8:30 pm ET

    Title: Results from Phase Ib study of tebentafusp (tebe) in combination with durvalumab (durva) and/or tremelimumab (treme) in metastatic cutaneous melanoma

    • Poster #: 546
    • Author: Omid Hamid
    • Location: Poster Hall (Hall E)
    • Date & Time: November 13th - 12:30-2:00 pm and 7:00-8:30 pm ET

    Title: Updated survival of patients with previously treated metastatic uveal melanoma who received tebentafusp

    • Poster #: 538
    • Author: Joseph J. Sacco

    Title: Selective affinity-enhanced T cell receptor bispecific targeting of KRASG12D neoantigen driven cancers

    • Poster #: 882
    • Author: Andrew Poole
    • Location: Poster Hall (Hall E)
    • Date & Time: November 13th - 12:30-2:00 pm and 7:00-8:30 pm ET

    Title: IL-2 Combination with ImmTAC Overcomes CD163+ Macrophage Inhibition of Redirected T Cell Killing of Tumour Cells

    • Poster #: 571
    • Author: Esra Güç
    • Location: Poster Hall (Hall E)
    • Date & Time: November 12th - 12:40-2:10 pm and 7:00-8:30 pm ET

    Title: Radiomic Markers Associated with Clinical Benefit in Advanced Uveal Melanoma Patients with Radiographic Progression on Tebentafusp

    • Poster #: 819
    • Author: Volkan Beylergil

    Virtual ePosters presented at the conference will be made available throughout the SITC 36th Annual Meeting on the SITC 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 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 are not limited to, statements regarding the efficacy, safety and therapeutic potential of tebentafusp; the clinical development of tebentafusp; 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; 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:

    Follow on Twitter: @Immunocore

    Consilium Strategic Communications (corporate and financial)

    Mary-Jane Elliott/ Chris Welsh/ Jessica Hodgson

    T: +44 (0)203 709 5700

    E:

    Investor Relations  

    Clayton Robertson, Head of Investor Relations

    T: +1 215-384-4781

    E:



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