Immunocore announces reimbursement agreement in England for KIMMTRAK▼ for the treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma

(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & GAITHERSBURG, Md., US, 03 December 2024) Immunocore Holdings plc (Nasdaq: IMCR) (“Immunocore” or the “Company”), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, today announced that KIMMTRAK (tebentafusp) has been recommended for funding through the National Health Service (NHS) in England by the National Institute for Health and Care Excellence (NICE).

NICE recommended KIMMTRAK within its marketing authorization for the treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma. The recommendation overturns the initial negative decision by NICE in May 2023, which the Company successfully appealed in December 2023.

“I am delighted for patients and their families that NICE have now recommended tebentafusp as a treatment option for HLA-A*02:01-positive metastatic or unresectable uveal melanoma,” said Professor Paul Nathan, Consultant Medical Oncologist at Mount Vernon Cancer Centre, UK. “Access to the first therapy that improves survival for this rare and threatening disease marks a major step forward. There remains much work to be done to build upon this advance so that we can further improve outcomes for all patients.”

“Today is a landmark day for the uveal melanoma community, with NICE’s recommendation of the first treatment to prolong survival in HLA-A*02:01-positive adults with metastatic or unresectable uveal melanoma. Uveal melanoma is a very rare form of melanoma which requires different clinical management. The option to prescribe tebentafusp is a step change for patients and their families, and we continue to support the process so that there is reimbursement for the therapy across the UK for all eligible patients,” said Susanna Daniels, CEO of Melanoma Focus.

"The recommendation of tebentafusp by NICE is a groundbreaking moment for individuals with metastatic uveal melanoma. For the first time, HLA-A*02:01-positive patients with this condition will have access to an effective treatment, which offers new hope in the fight against this rare cancer,” said Jo Gumbs, CEO and Founder of Ocular Melanoma UK. “We are especially proud to have represented our patient community in the appraisal process. This recommendation highlights the power of collaboration between patients, advocates, and medical experts. We remain committed to advancing care and support for people with ocular melanoma and thank everyone who has contributed to this monumental milestone.”
“I am pleased that patients in England can now have access to KIMMTRAK, marking our 13th launch this year,” said Ralph Torbay, Immunocore’s Chief Commercial Officer.” This decision by NICE, following two decades of pioneering research at our laboratories in Oxford, underscores the strength of UK science in transforming innovation into a medicine that benefits patients worldwide.”

KIMMTRAK is now funded on the NHS in England as of 03 December 2024.

About Uveal Melanoma

Uveal melanoma is a rare and aggressive form of melanoma affecting the eye. Although it is the most common primary intraocular malignancy in adults, the diagnosis is rare, and up to 50% of people with uveal melanoma will eventually develop metastatic disease. Unresectable or metastatic uveal melanoma typically has a poor prognosis and had no approved treatment until KIMMTRAK.

About KIMMTRAK^®

KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. KIMMTRAK specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma. This is the first molecule developed using Immunocore’s ImmTAC technology platform, designed to redirect and activate T cells to recognize and kill tumor cells. KIMMTRAK has been approved for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in the United States, European Union, Canada, Australia, and the United Kingdom.

KIMMTRAK▼ (tebentafusp) is indicated as monotherapy for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM).

For more information, please see full Summary of Product Characteristics (SmPC): https://www.medicines.org.uk/emc/product/13842/smpc/print.

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Side effects should be reported directly via the Yellow Card Scheme: https://yellowcard.mhra.gov.uk/.

About ImmTAC^® molecules for cancer

Immunocore’s proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilizing monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognize and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognize 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 tumors, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumors, regardless of mutational burden or immune infiltration, including immune “cold” low mutation rate tumors.

About Immunocore

Immunocore is a commercial-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, autoimmune diseases and infectious diseases. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including nine active clinical and pre-clinical programs in oncology, infectious diseases, and autoimmune diseases. The Company’s most advanced oncology TCR therapeutic, KIMMTRAK, has been approved for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in the United States, European Union, Canada, Australia, and the United Kingdom.

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “may”, “will”, “believe”, “expect”, “plan”, “anticipate” and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These statements include, but are not limited to, statements regarding the potential benefits and advantages that KIMMTRAK will provide for patients, including survival benefits. Any forward-looking statements are based on management’s current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual events or 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 impact of worsening macroeconomic conditions on the Company’s business, financial position, strategy and anticipated milestones, including Immunocore’s ability to conduct ongoing and planned clinical trials; Immunocore’s ability to obtain a clinical supply of current or future product candidates or commercial supply of KIMMTRAK or any future approved products; Immunocore’s ability to obtain and maintain regulatory approval of its product candidates, including KIMMTRAK; Immunocore’s ability and plans in continuing to establish and expand a commercial infrastructure and to successfully launch, market and sell KIMMTRAK and any future approved products; Immunocore’s ability to successfully expand the approved indications for KIMMTRAK or obtain marketing approval for KIMMTRAK in additional geographies in the future; the delay of any current or planned clinical trials, whether due to patient enrollment delays or otherwise; Immunocore’s ability to successfully demonstrate the safety and efficacy of its product candidates and gain approval of its product candidates on a timely basis, if at all; competition with respect to market opportunities; unexpected safety or efficacy data observed during preclinical studies or clinical trials; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials or future regulatory approval; Immunocore’s need for and ability to obtain additional funding, on favorable terms or at all, including as a result of worsening macroeconomic conditions, including changes in inflation and interest rates and unfavorable general market conditions, and the impacts thereon of the war in Ukraine, the conflict in the Middle East, and global geopolitical tension; Immunocore’s ability to obtain, maintain and enforce intellectual property protection for KIMMTRAK or any of its product candidates it or its collaborators are developing; and the success of Immunocore’s current and future collaborations, partnerships or licensing arrangements. These and other risks and uncertainties are described in greater detail in the section titled "Risk Factors" in Immunocore’s filings with the Securities and Exchange Commission, including Immunocore’s most recent Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission on February 28, 2024, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the SEC. 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 Information

Immunocore
Sébastien Desprez, Head of Communications
T: +44 (0) 7458030732
E: sebastien.desprez@immunocore.com
Follow on Twitter: @Immunocore

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

Source: Immunocore Holdings plc

Released December 3, 2024