Immunocore announces clinical trial collaboration and supply agreement with Bristol Myers Squibb to evaluate IMC-F106C (PRAME HLA-A02) in combination with nivolumab in its registrational Phase 3 first-line advanced cutaneous melanoma trial
2024-02-26
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Immunocore announces clinical trial collaboration and supply agreement with Bristol Myers Squibb to evaluate IMC-F106C (PRAME HLA-A02) in combination with nivolumab in its registrational Phase 3 first-line advanced cutaneous melanoma trial
IMC-F106C is Immunocore’s first-in-class bispecific TCR ImmTAC candidate targeting PRAME HLA-A02; nivolumab is manufactured by Bristol Myers Squibb
The clinical trial collaboration relates to Immunocore’s PRISM-MEL-301 registrational Phase 3 clinical trial in first-line advanced cutaneous melanoma, evaluating IMC-F106C in combination with nivolumab versus a control arm of either nivolumab or the fixed-dose combination of nivolumab and relatlimab
(22 February 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 it has entered into a clinical trial collaboration and supply agreement with Bristol Myers Squibb (NYSE:BMY) to investigate Immunocore’s ImmTAC bispecific TCR (T cell receptor) candidate targeting PRAME HLA-A02, IMC-F106C, in combination with Bristol Myers Squibb’s nivolumab, in first-line advanced cutaneous melanoma.
Under the terms of the collaboration, Immunocore will sponsor and fund the registrational Phase 3 clinical trial of IMC-F106C in combination with nivolumab in first-line advanced cutaneous melanoma (PRISM-MEL-301), and Bristol Myers Squibb will provide nivolumab.
The PRISM-MEL-301 trial will randomize HLA-A*02:01+ first-line advanced cutaneous melanoma patients to IMC-F106C + nivolumab versus a control arm of either nivolumab or the fixed-dose combination of nivolumab and relatlimab, depending on the country where the patient is enrolled. Immunocore plans to randomize the first patient in this trial in the first quarter of 2024.
About PRISM-MEL301 – Phase 3 trial with IMC-F106C (PRAME HLA-A02) in 1L advanced cutaneous melanoma
The Phase 3 registrational trial (NCT06112314) will randomize patients with previously untreated, HLA-A*02:01 positive, advanced melanoma to IMC-F106C + nivolumab versus nivolumab or the fixed-dose combination of nivolumab and relatlimab, depending on the country where the patient is enrolled. The trial will initially randomize to three arms: two IMC-F106C dose regimens (40 mcg and 160 mcg) and control arm and will discontinue one of the F106C dose regimens after an initial review of the first 60 patients randomized to the two experimental arms (90 patients randomized total). The primary endpoint of the trial is progression free survival (PFS) by blinded independent central review (BICR), with secondary endpoints of overall survival (OS) and overall response rate (ORR), as well as safety.
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, and infectious disease. 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. 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.
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