EU Approves Immunocore’s Kimmtrak for Patients With Unresectable/Metastatic Uveal Melanoma
The European Commission has approved Immunocore’s T-cell receptor (TCR) bispecific immunotherapy drug Kimmtrak (tebentafusp) for HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma — the first regulatory approval for a TCR treatment in the EU.
The European Medicines Agency’s recommendation for approval was supported by positive phase 3 study results. In the clinical trial, which enrolled 378 participants, the primary endpoint of overall survival was met, with patients in the Kimmtrak group achieving 73 percent overall survival at one year compared with 59 percent in the investigator’s choice of therapy group.
The FDA approved Kimmtrak for HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in January.
About Immunocore
Immunocore is a global commercial-stage biotechnology company, based in Oxfordshire, which researches and develops biological drugs using soluble T-cell receptor technology.
Immunocore was founded in 2008 as a spinout of MediGene AG, which acquired Avidex in 2006. The core technology was spun out of Oxford University in 1999 by Dr Bent Jakobsen into Avidex Ltd.
In September 2017, the Bill & Melinda Gates Foundation announced a $40 million investment in Immunocore to accelerate the development of Immunocore’s ImmTAV and ImmTAB therapeutics.
In March 2020, Immunocore announced the closing of its $130 million Series B private financing round. In January 2021, Immunocore announced the closing of its $75 million Series C round. Immunocore went public in February 2021, with closing announced on February 9, 2021.
April 6, 2022