French pharmaceutical firms Sanofi and Transgene have started the construction of the manufacturing platform dedicated to the production of viral vectors such as TG4010, a subcutaneously administered cancer vaccine based on Co-X-Gene Technology.
Being built on the Genzyme Polyclonals site in Lyon, France, the new production unit will cost €10m over two years, with each company financing half the cost.
The new unit will be dedicated to production of viral vectors via 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.
Under the deal, Sanofi will provide to Transgene its know-how in bioproduction and experience in launching biologics.
Transgene chairman and chief executive officer Philippe Archinard said: "Our decision to invest now reflects the increasing confidence in our programmes, including our cancer immunotherapy candidate, TG4010, for which we recently announced topline preliminary data from a clinical study in non-small cell lung cancer."
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Through the Genzyme Polyclonals site for the manufacturing and the CEPIA organisation (Commercial & External Partnership Industrial Affairs) for all commercial aspects, Sanofi will act as Transgene’s contract manufacturing organisation (CMO) and Transgene will be the preferred customer of the platform through 2028.
Following completion, the production unit will be Sanofi’s exclusive property that will help it produce a new breakthrough class of APIs (Viral vectors).
Transgene’s MUC1 targeted cancer immunotherapy TG4010 uses the Modified Vaccinia Ankara virus vector, a poxvirus that combines distinguishing advantages for an optimized systemic vaccination.
It is currently under development for the treatment of metastatic non-small cell lung cancer.
TG4010 expresses the entire MUC1 gene sequence and has the potential to generate an immune response to all antigenic epitopes of MUC1, a major tumor-associated antigen that provides a viable target for immunotherapy.
Image: MUC1 is a major tumor-associated antigen that provides a viable target for immunotherapy. Photo: courtesy of freedigitalphotos.net.
