Sanofi and Transgene SA have announced that they have launched the construction phase of the manufacturing platform dedicated to the production of viral vectors, such as Transgene’s MUC1 targeted cancer immunotherapy, TG4010.
In March 2013, the companies announced a long-term collaboration agreement to build the unit, which is to be constructed on the Genzyme Polyclonals site in Lyon, an important French biopharmaceutical cluster.
Philippe Luscan, Executive VP Industrial affairs Sanofi, said: “We are very pleased to partner with Transgene, an innovative French Biopharmaceutical company developing new drugs which might be a breakthrough in the treatment of life threatening diseases. This state-of- the art industrial platform will be dedicated to production of viral vectors through a broad range of technologies including mammalian cell culture up to 1m3 using single use bioreactors, combining the excellence of Genzyme, Sanofi-pasteur, and Transgene in Lyon area. Sanofi will bring to Transgene its know-how in bioproduction and experience to launch biologics. It reflects the core elements required in improving global health, innovation & partnership”.
Philippe Archinard, Chairman and Chief Executive Officer of Transgene, said: “We are very pleased to be moving forward with the construction phase of this important new commercial production unit. Our decision to invest now reflects the increasing confidence in our programs, including our cancer immunotherapy candidate, TG4010, for which we recently announced topline preliminary data from a clinical study in non-small cell lung cancer. We are building a strong future for Transgene and are taking the steps needed to ensure sufficient future commercial supply.” Mr Archinard continued: “Sanofi is an ideal partner with extensive experience in effectively managing large production projects and manufacturing novel therapies in commercial quantities.”
The companies together will invest approximately €10 million in the production unit over an expected two-year timeframe, of which Transgene’s share will be approximately €5 million.
SANOFI, through its Genzyme Polyclonals site for the manufacturing and the CEPIA organization (Commercial & External Partnership Industrial Affairs) for all commercial aspects, will act as Transgene’s Contract Manufacturing Organization (CMO) and Transgene will be considered a preferred customer of the platform through 2028.
This dedicated platform will be Sanofi’s exclusive property and will enable to produce a new breakthrough class of APIs (Viral vectors).