On April 28, 2014 Transgene reported that Novartis has informed the Company that it will not exercise its option for the global development and commercialization rights to TG4010 MUC1 targeted cancer immunotherapy (Press release, Transgene, APR 28, 2014, View Source [SID:1234502167]). As a result, Transgene retains all rights to the program.
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"We regret that Novartis has chosen not to use its exclusivity period to opt-in and become our global partner for TG4010," said Philippe Archinard, Chairman and Chief Executive Officer of Transgene. He added: "We are committed to start a Phase 3 trial in advanced lung cancer as rapidly as possible as the data obtained with this cancer immunotherapy are compelling, and we are well financed to move our plans forward.
In parallel, we will now be actively looking for a partner to co-develop and commercialize TG4010. A variety of global players active in the field of cancer immunotherapy have already expressed interest in the program."
Plans for the Phase 3 part of the TIME trial in MUC1+ patients with Stage IV non-small cell lung cancer (NSCLC) are well advanced, and Transgene is working to move into Phase 3 in the second half of this year, contingent on discussions with regulatory authorities.
The data from the Phase 2b part of the TIME trial continue to mature; Transgene expects detailed results to be presented at a major medical meeting later this year.