Immunocore has signed a clinical trial collaboration and supply agreement with Bristol Myers Squibb (BMS) to develop its drug IMC-F106C as a combination treatment for cutaneous melanoma.
IMC-F106C, a first-in-class TCR bispecific protein targeting preferentially expressed antigen in melanoma (PRAME) HLA-A02, was developed based on Immunocore’s proprietary ImmTAC technology. It will be evaluated in combination with BMS’ PD-1 inhibitor Opdivo (nivolumab) as a treatment for previously untreated advanced cutaneous melanoma in a registrational Phase III trial (NCT06112314) dubbed PRISM-MEL-301.
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The study will randomise approximately 680 patients into three arms where patients will receive experimental regimens of 40mcg IMC-F106C plus Opdivo or 160mcg IMC-F106C plus Opdivo, or an active comparator arm of either Opdivo or a fixed-dose combination of Opdivo and Opdualag. BMS’ Opdualag is a combination of nivolumab and the LAG-3 antibody relatilimab. Progression-free survival (PFS) for up to 24 months will be used as the study’s primary endpoint. Immunocore expects to randomise the first patient in Q1 2024, the company wrote in the 22 February press release.
As per the agreement, Immunocore will sponsor and fund the clinical study while BMS will manufacture and provide Opdivo.
GlobalData’s consensus forecasts expect that IMC-F106C will yield $614m in 2029.
Aside from the collaboration with BMS, the UK-based Immunocore has an active research collaboration with Delfi Diagnostics to evaluate the Baltimore, Maryland-based company’s DELFI-Tumor Fraction (DELFI-TF) assay’s potential in early prediction of treatment benefits from Immunocore’s ImmTAC-based therapies.
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By GlobalDataAs per a 5 January press announcement, Immunocore is also looking to expand the global footprint of Kimmtrak (tebentafusp), which became the first US Food and Drug Administration (FDA)-approved treatment for uveal melanoma in 2022. The company is also studying the therapy in other types of melanoma, including a Phase II/III study (NCT05549297) in advanced cutaneous melanoma, Phase II topline data is anticipated in Q4 2024.
GlobalData, the parent company of Pharmaceutical Technology, estimates that Kimmtrak will bring in $552m in 2029.
