GT portfolio company Immunocore Holdings plc (Nasdaq: IMCR) announces approval from the United States Food and Drug Administration (FDA) of KIMMTRAK® (tebentafusp-tebn) for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM), the most common primary cancer within the eye in adults.
This approval establishes many firsts:
n The first TCR therapeutic to receive regulatory approval from the FDA
n The first bispecific T cell engager to receive regulatory approval from the FDA to treat a solid tumor
n The first and only therapy for the treatment of unresectable or metastatic uveal melanoma to be approved by the FDA
Bahija Jallal, CEO of Immunocore, said: “Today’s approval of KIMMTRAK is a historic milestone and the culmination of years of dedication by the Immunocore team, patients, and our healthcare partners. KIMMTRAK is the first therapy to demonstrate a survival benefit to patients with this disease and we are focused on making KIMMTRAK available as quickly as possible.
Mingxi Li, Partner of GT Healthcare Capital Partners commented: “This deeply resonates with us as a stellar example of innovative technologies creating impact in patient lives, and building hope for the individuals and families of those diagnosed with the deadliest form of eye cancer who, until now, had no approved treatment options.”
Full press release: https://bit.ly/33PunnY
Immunocore Holdings plc
Immunocore Holdings plc (Nasdaq: IMCR) is a commercial-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, autoimmune and infectious diseases.