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

Rhea-AI Summary

Immunocore Holdings Plc (Nasdaq: IMCR) will present new data from its lead program, tebentafusp, at the European Society for Medical Oncology (ESMO) Congress 2021 from September 16-21. Key presentations include an oral presentation on ctDNA reduction associated with overall survival in metastatic uveal melanoma and several poster presentations focused on the efficacy and side effects of tebentafusp. This highlights Immunocore's innovative T cell receptor (TCR) bispecific immunotherapy platform aimed at cancer treatment and its potential impact on patient outcomes.

PRESS RELEASE

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

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

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

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

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

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

Title: Demonstration of T cell redirection and immune activation in skin rash following tebentafusp treatment

• Abstract ID: 1772P
• Presenter: Ramon Stäger

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

• Abstract ID: 1014P
• Presenter: April Salama

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

• Abstract ID: 1018P
• Presenter: Bartosz Chmielowski

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

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

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

• Poster #: 1016P
• Presenter: Kristina Petrovic

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

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

The abstracts referenced above our available on the ESMO website.

About Immunocore

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

About Tebentafusp

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

About ImmTAC^® Molecules

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

Forward Looking Statements

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

CONTACT: 

Immunocore
Debra Nielsen, Head of Communications
T: +1 (610) 368-8602
E: debra.nielsen@immunocore.com
Follow on Twitter: @Immunocore

Consilium Strategic Communications (corporate and financial)
Mary-Jane Elliott/ Chris Welsh/ Jessica Hodgson
T: +44 (0)203 709 5700
E: Immunocore@consilium-comms.com

Investor Relations  
Clayton Robertson, Head of Investor Relations
T: +1 215-384-4781
E: ir@immunocore.com

FAQ

What is the significance of Immunocore's presentations at ESMO Congress 2021?

Immunocore's presentations at ESMO Congress 2021 highlight new findings regarding its lead program, tebentafusp, which is aimed at improving treatment outcomes in metastatic uveal melanoma.

What is tebentafusp and its role in cancer treatment?

Tebentafusp is a bispecific protein developed by Immunocore that targets gp100, aiming to enhance T cell activity against melanoma cells, showing promise in treating metastatic uveal melanoma.

What are the key findings presented about tebentafusp at ESMO?

Key findings include the association of early ctDNA reduction with improved overall survival in patients and various insights into immune activation and side effects following tebentafusp treatment.

When will the data from Immunocore be available to the public?

The full dataset from Immunocore's presentations will be available on September 17, 2021, following the ESMO Congress.

What designations has tebentafusp received from regulatory authorities?

Tebentafusp has been granted Breakthrough Therapy, Fast Track, and Orphan Drug designations by the FDA, among others, indicating its potential significance in treating metastatic uveal melanoma.