IMCR Immunocore Holdings plc

37.49
-1.75  -4%
Previous Close 39.24
Open 39.28
52 Week Low 30.9185
52 Week High 61.9899
Market Cap $1,641,540,439
Shares 43,786,088
Float 43,786,088
Enterprise Value $1,446,460,123
Volume 42,772
Av. Daily Volume 57,079
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Upcoming Catalysts

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Tebentafusp
Uveal melanoma
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IMC-C103C - MAGE-A4
Solid tumors
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IMC-F106C (PRAME)
Solid tumors
Phase 1
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GSK01
Synovial sarcoma
Phase 1
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Latest News

  1. PRESS RELEASE

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

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

    PRESS RELEASE

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

    2021 American Society of Clinical Oncology (ASCO) Annual Meeting

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

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

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

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

    _______________________________________

    *Response Evaluation Criteria in Solid Tumors

    CLINICAL SCIENCE SYMPOSIUM

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

    Presenter: Anthony Joshua, MD

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

    Session: Management of Rare Melanoma Subtypes

    Abstract ID: 9509

    POSTER PRESENTATIONS

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

    Session: Melanoma/Skin Cancers

    Abstract ID: 9527

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

    Session: Melanoma/Skin Cancers

    Abstract ID: 9526

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

    Session: Melanoma/Skin Cancers

    Abstract ID: 9531

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

    ##

    About Immunocore

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

    About ImmTAC® Molecules

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

    About Tebentafusp

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

    About Uveal Melanoma

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

    Forward Looking Statements

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

    CONTACT: 

    Immunocore

    Debra Nielsen, Head of Communications

    T: +1 (610) 368-8602

    E:

    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. PRESS RELEASE

    Immunocore to present at upcoming investor conferences

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

    • Jefferies Virtual Healthcare Conference

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

    • Goldman Sachs 42nd Annual Global Healthcare Conference

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

    The investor conferences will each be held in a…

    PRESS RELEASE

    Immunocore to present at upcoming investor conferences

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

    • Jefferies Virtual Healthcare Conference



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

    • Goldman Sachs 42nd Annual Global Healthcare Conference



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

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

    ##

    About Immunocore

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

    Forward Looking Statements

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

    CONTACT: 

    Immunocore

    Debra Nielsen, Head of Communications

    T: +1 (610) 368-8602

    E:

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

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

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

    PRESS RELEASE

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

    IMC-I109V studied for the treatment of non-cirrhotic

    HBeAg-negative chronic hepatitis B (HBV) infection

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

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

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

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

    - Ends -

    About ImmTAV molecules and infectious diseases

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

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

    About Immunocore

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

    Forward Looking Statements

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

    CONTACT: 

    Immunocore

    Debra Nielsen, Head of Communications

    T: +1 (610) 368-8602

    E:

    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 First Quarter 2021 Financial Results

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

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

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

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

    PRESS RELEASE

    Immunocore Reports First Quarter 2021 Financial Results

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

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

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

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

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

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

    First Quarter 2021 Highlights (including post-period)

    Tebentafusp

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

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

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

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

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

    Additional Clinical Programs

    IMC-C103C – MAGE-A4

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

    IMC-F106C – PRAME

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

    IMC-I109VHBV

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

    Operational Highlights

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

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

    Financial Results

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

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

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

    ##

    About Immunocore

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

    Forward Looking Statements

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

    CONTACT: 

    Immunocore

    Debra Nielsen, Head of Communications

    T: +1 (610) 368-8602

    E:

    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:



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



    Consolidated Statement of Loss for Each Period Presented:

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



     For the three months ended



    March 31

    2021
     For the three months ended



    March 31,

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



    Condensed Consolidated Statement of Cash Flows for Each Period Presented:

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



    Consolidated Statements of Financial Position for Each Period Presented:

     March 31,

    2021

    £'000
     December 31,

    2020

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







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  5. PRESS RELEASE

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

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

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

    PRESS RELEASE

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

    Overall survival benefit from tebentafusp in patients with best response

    of progressive disease subject of oral presentation

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

    CLINICAL SCIENCE SYMPOSIUM

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

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

    Session: Management of Rare Melanoma Subtypes

    Abstract ID: 9509

    POSTER PRESENTATIONS

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

    Session: Melanoma/Skin Cancers

    Abstract ID: 9527

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

    Session: Melanoma/Skin Cancers

    Abstract ID: 9526

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

    Session: Melanoma/Skin Cancers

    Abstract ID: 9531

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

    About Immunocore

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

    About Tebentafusp

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

    Forward Looking Statements

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

    CONTACT: 

    Immunocore

    Debra Nielsen, Head of Communications

    T: +1 (610) 368-8602

    E:

    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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