The POSITIVE project will focus on the development and establishment of a procedure to automate the first step of manufacturing of Ovasave, TxCells lead innovative, personalized cellular immunotherapy for severe refractory Crohns disease patients. Biosafes Sepax system will enable the automated and standardized separation of mononuclear white blood cells for the production of cellular immunotherapy.

This collaborative project, accredited by the French competitive cluster Eurobiomed, is supported by APRF funding (Appel Projet Recherche Finalise), from the Conseil Rgional Provence-Alpes-Cte-Dazur. The grant totals EUR 417,000, of which TxCell will receive a grant of EUR 250,000 and UTCG will receive EUR 167,000. Both grants will be for the performance of experiments by TxCell and UTCG and the optimization of the resulting new automated and standardized procedure. Biosafe will also utilise its Sepax technology expertise and know-how to optimize the dedicated software and protocol.

Participating in the POSITIVE project, and automating the TxCell manufacturing process for Ovasave is very important to us following the partnership with Ferring announced earlier this year with a potential value of EUR 76 million plus royalties, said Damian Marron, CEO, TxCell. Working with our highly qualified partners from UTCG and Biosafe, and backed by the Conseil Rgional Provence-Alpes-Cte-Dazur, Ovasave will be able to pave the way for scale up, industrialisation and commercialisation of cellular immunotherapies for TxCell, other biotech companies and public institutions. This is the next step following the announcement of our certification of GMP by the ANSM.

The process developed by the POSITIVE project will be applicable to a wide range of other cellular immunotherapies, allowing to overcome the constraints of manual methods and to move towards standardized large scale manufacturing in closed systems.

The industrialization of cellular immunotherapies is crucial for those operating in the sector as well as for TxCell, said Eric Pottier, VP Supply Chain at TxCell. New industrial tools are needed to enable commercial scale manufacturing. This could make cellular immunotherapies available to the large number of patients with a variety of conditions with unmet medical need that are waiting for innovative therapeutic options.

About TxCell

TxCell is developing innovative personalized cell-based immunotherapies for the treatment of severe chronic inflammatory diseases with high medical need using its unique and proprietary ASTrIA technology platform based on the properties of autologous antigen-specific regulatory T lymphocytes (Ag-Tregs). The company has completed a phase I/IIa study of its lead product candidate, Ovasave in refractory Crohns disease patients and has reported good tolerability and positive clinical efficacy. The company plans to initiate a phase IIb study in the same patient population. TxCell has a strategic partnership for Ovasave with the Swiss company Ferring International Center. Listed on Euronext-Paris, TxCell, a spin-off of Inserm (Frances National Institute for Health and Medical Research) is located in the Sophia Antipolis technology park, Nice, France. The company has 38 employees based at its headquarters and at its manufacturing site in Besanon.

For more information, please visitwww.txcell.com

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TxCell to lead POSITIVE project to automate first production step of Ovasave, its lead personalised cellular ...

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