Date: 2014-04-28
Type of information: Refusal of an option
Compound: TG4010 (MVA-MUC1-IL2)
Company: Transgene (France) Novartis (Switzerland)
Therapeutic area: Cancer - Oncology
Type agreement:
Action mechanism: TG4010 (MVA-MUC1-IL2) uses the Modified Vaccinia Ankara virus vector, a poxvirus that combines distinguishing advantages for an optimized systemic vaccination. MVA is a highly attenuated strain which has been tested extensively in humans as a smallpox vaccine and is known to strongly stimulate innate and adaptive immune responses to antigens.
Disease: advanced non-small cell lung cancer
Details:
Financial terms:
Latest news: * On April 28, 2014, Transgene has announced 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. As a result, Transgene retains all rights to the program. Transgene said that the company is 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. The company will be actively looking for a partner to co-develop and commercialize TG4010. 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, probably at the next ESM congress. * On March 10, 2010, Transgene and Novartis have signed an exclusive option agreement for the development and commercialisation of Transgene’s targeted immunotherapy product, TG4010 (MVA-MUC1-IL2), for the first-line treatment of non-small cell lung cancer (NSCLC) and other potential cancer indications. Pursuant to the agreement, Transgene has granted Novartis an option to acquire an exclusive worldwide license for TG4010 and Novartis will pay Transgene a $10 million non-refundable option fee. Contingent upon the exercise of the option by Novartis and the achievement of successful development, regulatory and commercial milestones in various indications, According to the agreement, Transgene will initially fund and retain control over the next clinical development phase of TG4010, which is a pivotal, global phase IIb/III clinical trial.
