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


PPRESS RELEASE

Immunocore presentclinical The data further characterizing the overall survival benefit of tebentafuspin metastatic uveal melanoma at
2021 American Society of Clinical Oncology (ASCO) Annual Meeting

(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Maryland, United States, June 04, 2021) Immunocore (Nasdaq: IMCR), an advanced biotechnology company pioneering the development of a new class of bispecific T cell receptor (TCR) immunotherapies designed to treat a wide range of diseases, including cancer, infections and autoimmune diseases, announces the presentation of a subset analysis of the phase 3 study exploring the overall survival benefit of tebentafusp in patients with the best RECIST * response to progressive disease at the meeting American Society of Clinical Oncology (ASCO) annual meeting to be held virtually June 4-8, 2021.

“As a pioneer in the class of T cell receptor therapy, we will continue to analyze the science and clinical data behind the survival benefit of tebentafusp, which will also help advance the field of TCR bispecies,” said said David Berman, head of research and development at Immunocore. “At ASCO this year, we presented a more in-depth review of the phase 3 trial of tebentafusp, including an overall survival benefit of tebentafusp in patients with the best response to progressive disease. “

In patients with a better disease progression (PD) response in the phase 3 trial, overall survival (OS) was better for the tebentafusp arm compared to the investigator’s chosen arm with a hazard ratio (HR ) 0.43 (95% CI 0.27-0.68). More than half of tebentafusp patients with the best PD response 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 tebentafusp patients with an improved PD response have a reduction in circulating tumor DNA and that this may be associated with SG longer.

Tebentafusp has received Breakthrough Therapy designation, Fast Track designation and Orphan Drug designation from the United States Food and Drug Administration (FDA) and Promising Innovative Medicine (PIM) designation under the UK program early access to drugs for metastatic uveal melanoma. Immunocore will work with the FDA to finalize the submission of a BLA for tebentafusp in the third quarter of 2021.

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* Criteria for evaluating response in solid tumors

SYMPOSIUM OF CLINICAL SCIENCES

Title: Overall survival benefit of tebentafusp in patients with the best response to disease progression
Presenter: Anthony Joshua, MD
Date and houre: June 4, 2021; 9:00 a.m. EDT
Session: Management of rare melanoma subtypes
Abstract identifier: 9509

POSTER PRESENTATIONS

Title: Co-primary endpoint of overall survival for tebentafusp (tebe) -induced rashes in a phase 3 randomized trial comparing tebe vs choice of investigator (CI) in first-line metastatic uveal melanoma
Session: Melanoma / skin cancer
Abstract identifier: 9527

Title: Overall Survival in Patients Receiving Checkpoint Inhibitors After Completing Tebentafusp in a Phase 3 Randomized First-Line Metastatic Uveal Melanoma Trial
Session: Melanoma / skin cancer
Abstract identifier: 9526

Title: Characterization of cytokine release syndrome (CRS) after treatment with tebentafusp in patients (pts) with previously treated metastatic uveal melanoma (mUM) (2L +).
Session: Melanoma / skin cancer
Abstract identifier: 9531

Due to the virtual format, all oral, poster and poster discussion sessions, as well as Track Clinical Science Symposia, will be available upon request, starting June 4, 2021 at 9 a.m. EDT, for registered attendees. at the conference.

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About Immunocore

Immunocore is an advanced-stage biotechnology company pioneering the development of a new class of bispecific TCR immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a wide range of diseases, including cancer, infectious and autoimmune diseases. Building on its proprietary, flexible and out-of-the-box ImmTAX platform, Immunocore is developing an in-depth pipeline across multiple therapeutic areas, including five clinical stage programs in oncology and infectious diseases, advanced preclinical programs in diseases autoimmune and several previous preclinical programs. programs. Immunocore’s most advanced oncology candidate, tebentafusp, demonstrated overall survival benefit in a randomized phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically been unresponsive to others immunotherapies.

Afight ImmTAC® Molecules

Immunocore’s proprietary T cell receptor (TCR) technology generates a new class of bispecific biological molecules called ImmTAC (Immune mobilizing monoclonal TCRs Against Cancer) which are designed to redirect the immune system to recognize and kill cancer cells. ImmTAC molecules are soluble TCRs designed to recognize intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an effector function of anti-CD3 immune activation. Based on the demonstrated mechanism of T cell infiltration in human tumors, the mechanism of action of ImmTAC has the potential to treat hematologic and solid tumors, regardless of mutational load or immune infiltration, including low mutation rate “cold” immune tumors.

About Tebentafusp

Tebentafusp is a novel bispecific protein composed of a soluble T cell receptor fused with 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 recognize and kill tumor cells . Tebentafusp has received Breakthrough Therapy, Fast Track 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 in the clinical trials of tebentafusp 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 generally has a poor prognosis and has no currently accepted optimal management or treatment. Although it is the most common primary intraocular malignancy in adults, diagnosis is rare, with approximately 8,000 new patients diagnosed worldwide each year (1,600 to 2,000 cases per year in the United States. United). Up to 50% of people with uveal melanoma will eventually develop metastatic disease. When cancer spreads beyond the eye, only about half of patients will survive for a year.

Forward-looking statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the efficacy, safety and therapeutic potential of tebentafusp, design, the progress, timing, scope and results of the Company’s clinical trials, including IMCgp100-202, the expected timing of clinical trial results disclosure, plans to initiate future clinical trials and extension studies , the advancement of the Company’s development programs, including tebentafusp, the potential benefits of breakthrough therapy Orphan drug designation or designation for tebentafusp, the timing of regulatory filings, including estimates regarding the planned submission of a BLA for tebentafusp, the likelihood of obtaining regulatory approval for any of the Company’s product candidates, including tebentafusp, and the regulatory approval path for tebentafusp. All forward-looking statements are based on management’s current expectations regarding future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those stated or implied. through these forward-looking statements, many that are beyond the control of the Company. These risks and uncertainties include, but are not limited to, the impacts of the COVID-19 pandemic on the operations, clinical trials and financial condition of the Company; unexpected safety or efficacy data observed during preclinical studies or clinical trials; lower than expected activation or recruitment rates for clinical trial sites; 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, each of which could cause our actual results to differ from those contained in forward-looking statements, see the section entitled “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 publication, and the Company assumes no obligation to update such information, except as required by law.

CONTACT:

Immunocore
Debra Nielsen, Communication Manager
T: +1 (610) 368-8602
E: [email protected]
Follow on Twitter: @Immunocore

Consilium Strategic communications (corporate and financial)
Mary-Jane Elliott / Chris Welsh / Jessica Hodgson
T: +44 (0) 203 709 5700
E: [email protected]

Investor Relations
Clayton Robertson, Head of Investor Relations
T: +1 215-384-4781
E: [email protected]

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