“It’s going to be hopefully for the commercial manufacturing for our viral vector program there, including TG4010,” Laurie Doyle, spokeswoman for Transgene, told us. “TG4010 is actually expected to go into Phase III development later this year.”
The companies anticipate splitting the cost of the manufacturing facility, which is to be constructed on the Genzyme Polyclonals site in Lyon, France. Genzyme is a fully-owned subsidiary of Sanofi.
Philippe Luscan, executive VP of industrial affairs at Sanofi said the state-of-the art industrial site in Lyon will be dedicated to “the production of viral vectors through a broad range of technologies including mammalian cell culture up to 1m3 using single-use bioreactors.”
In March 2013, the companies announced a long-term agreement where Sanofi will act as Transgene’s CMO, while Transgene will be the preferred customer through 2028.
The move by Sanofi follows an announcement earlier this month where Sanofi agreed to manufacture antisense oligonucleotides for the German company Isarna.
Transgene recently announced results from a Phase IIb trial for which they manufactured product from another site in France, Doyle said. TG4010 proved effective in extending the progression-free survival of patients with advance NSCLC.
TG4010 is being developed to treat metastatic non-small cell lung cancer in combination with first-line chemotherapy. The product is based on a recombinant vaccinia virus expressing the MUC1 antigen and the human cytokine, Interleukin-2.
Doyle added that Sanofi will have enough space at the new site to manufacture products for other companies. No new employees will be brought onto the Lyon site until at least 2017.
Immunotherapies
The push by Sanofi and Transgene to begin production work on a new cancer immunotherapy reveals a glimmer of hope in what many consider to be a difficult field for advancing new products.
Many, however, consider the potential for combinations of different immunotherapies as opposed to checkpoint inhibitor monotherapy, according to media reports.
The advances come as more companies are looking to expand their manufacturing capacities for these immunotherapies.
Bristol-Myers Squibb, Merck, Roche and AstraZeneca are just a few of the companies getting into this area.