Immunocore and Medison Pharma Partner for F uture Commercializ ation of Tebentafusp in Canada , Central Eastern Europe , and Israel
(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US and PETACH TIKVAH, Israel, October 18, 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, and Medison Pharma Ltd., a global pharma company focused on providing access to highly innovative therapies to patients in international markets, today announced an exclusive multi-regional agreement for Medison to help seek regulatory authorization and commercialize Immunocore's tebentafusp (IMCgp100), for the treatment of patients with metastatic uveal melanoma, in Canada, twenty markets across Central Eastern Europe and Israel.
"Following the acceptances of the Biologics License Application and Marketing Authorization Application for tebentafusp in metastatic uveal melanoma by regulatory agencies in the U.S. and Europe, we are excited to partner with Medison Pharma to increase our potential ability to reach patients with metastatic uveal melanoma in many more countries," said Ralph Torbay, Head of Commercial at Immunocore.
"We are delighted to partner with Immunocore in 22 markets to accelerate the global reach of this breakthrough treatment for metastatic uveal melanoma", said Meir Jakobsohn, Founder and CEO of Medison Pharma. "In our joint commitment to help treat patients suffering from the most challenging diseases, we look forward to leveraging our commercial platform and providing patients in international markets with access to this much needed therapy."
Tebentafusp has been granted Priority Review; Real Time Oncology Review; Breakthrough Therapy designation; Fast Track designation; and orphan drug designation by the U.S. Food and Drug Administration (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 European Medicine Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP). Immunocore's biologics license application for approval of tebentafusp for the treatment of HLA-A*02:01-positive adult patients with metastatic uveal melanoma was recently accepted by the FDA. In addition, EMA's CHMP has accepted Immunocore's Marketing Authorisation Application.
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.
Medison is a global pharma company focused on providing access to highly innovative therapies to patients in international markets.
Medison is the first to create an international commercialization platform for highly innovative therapies, helping to save and improve lives by making the best available novel treatments accessible to patients in international markets. Medison has a track record of multi-territorial partnerships with leading pharmaceutical and biotech companies seeking to expand their global reach.
Medison is also an active investor in disruptive healthcare technologies and provides its partners with exposure to innovation in biotech and digital health. To learn more visit www.medisonpharma.com and follow us on LinkedIn.
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 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; 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; 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.
Immunocore Debra Nielsen, Head of CommunicationsT: +1 (610) 368-8602E: firstname.lastname@example.org Follow on Twitter: @Immunocore
Consilium Strategic Communications (corporate and financial)Mary-Jane Elliott/ Chris Welsh/ Jessica HodgsonT: +44 (0)203 709 5700E: Immunocore@consilium-comms.com
Investor Relations Clayton Robertson, Head of Investor RelationsT: +1 215-384-4781E: email@example.com
Medison Maya Nix, Corporate Communications LeadT: +972-3-925-0349E: firstname.lastname@example.org