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TXCELL TO LEAD POSITIVE PROJECT TO AUTOMATE FIRST PRODUCTION STEP OF OVASAVE(R), ITS LEAD PERSONALISED CELLULAR IMMUNOTHERAPY

Published by Gbaf News

Posted on July 4, 2014

3 min read

· Last updated: July 7, 2014

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Grant of over EUR 400,000 awarded by the Conseil Régional Provence-Alpes-Côte-D’azur to the consortium of TxCell, Gene and Cell therapy Unit, Nice (UTCG) and Biosafe

Overview of TxCell and Cellular Immunotherapy

TxCell SA, a biotech developing innovative, personalized cell-based immunotherapies using antigen-specific regulatory T-cells (Ag-Tregs) for chronic inflammatory and autoimmune diseases, announces today the launch of, and funding awarded to, the POSITIVE project in collaboration with the Gene and Cell therapy Unit (UTCG) developing new antiviral cell-based immunotherapies and Biosafe, a Swiss private company, a developer of innovative solutions for cell processing.

TXCELL TO LEAD POSITIVE PROJECT

TXCELL TO LEAD POSITIVE PROJECT

Objectives and Scope of the POSITIVE Project

The POSITIVE project will focus on the development and establishment of a procedure to automate the first step of manufacturing of Ovasave(R), TxCell’s lead innovative, personalized cellular immunotherapy for severe refractory Crohn’s disease patients. Biosafe’s Sepax system will enable the automated and standardized separation of mononuclear white blood cells for the production of cellular immunotherapy.

Funding and Consortium Details

This collaborative project, accredited by the French competitive cluster Eurobiomed, is supported by APRF funding (Appel à Projet Recherche Finalisée), from the Conseil Régional Provence-Alpes-Côte-D’azur. 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 POSITVE 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 Régional Provence-Alpes-Côte-D’azur, 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.”

Broader Impact on Cellular Immunotherapy

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.”

Key Takeaways

  • TxCell leads the POSITIVE project automating the first production step of its personalized immunotherapy Ovasave®.
  • The project, supported by a €417,000 regional grant, involves TxCell, UTCG Nice, and Swiss firm Biosafe.
  • Automation via Biosafe’s Sepax system aims to standardize mononuclear cell separation, accelerating scale-up and commercialization.

References

Frequently Asked Questions

What is the POSITIVE project?
A consortium initiative led by TxCell to automate the first manufacturing step of Ovasave® using Biosafe’s Sepax system, supported by a regional €417,000 grant.
Who are the partners in the POSITIVE project?
The project involves TxCell, the Gene and Cell Therapy Unit (UTCG) in Nice, and Biosafe, a Swiss cell‑processing company.
How is the funding allocated?
Out of the €417,000 APRF grant, TxCell receives €250,000 and UTCG receives €167,000 for experiments and process optimization.
What is Ovasave®?
Ovasave® is TxCell’s lead personalized cellular immunotherapy using antigen‑specific regulatory T‑cells to treat severe refractory Crohn’s disease.

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