TxCell names PCT as Ovasave contract manufacturer in the US

By Gareth Macdonald contact

- Last updated on GMT

PCT names as Ovasave CMO in the US
PCT names as Ovasave CMO in the US

Related tags: Immune system

TxCell has hired Caladrius Biosciences’ subsidiary PCT as its manufacturer in the US and has started looking for a CMO in Japan.

The deal will see PCT begin by assessing the manufacturing processes TxCell uses to make Ovasave, its candidate cell therapy for refractory Crohn’s disease.

TxCell CEO Stephane Boissel told us PCT's initial assessment "has been scheduled to be completed in the next few months.​"

"PCT has been working in process development in cell therapy for a number of years" ​Boissel said, adding that "they are already a process development company in CT, as well as a CMO. This is a key reason why TxCell chose them in a careful and considered selection process." 

If everything goes to plan PCT will make Ovasave for US clinical trials.

Ovasave was developed using TxCell's ASTrIA (Antigen Specific Treg for Inflammation and Autoimmunity) platform, which teaches patient-derived white blood cells to target inflammation associated with Crohn’s.

The ‘manufacturing’ part of the ASTrIA process involves culturing millions of these antigen-specific white blood cells - called Treg cells - which are then divided into doses and frozen.

Trial halt

TxCell halted a European Ph IIb study of Ovasave – codenamed CATS29​ – last year​ after regulator ANSM (Agence nationale de sécurité du medicament) raised concerns about the risk of microbial contamination at its manufacturing facility in Besancon.

Since then TxCell has been working to address ANSM’s concerns about its facility. It also hired Belgian CMO MaSTherCell in a bid to restart CATS29 this year.

MaSTherCell completed test production of Ovasave this month​.

The US Food and Drug Administration (FDA) accepted an IND for Ovasave last June​. PCT has manufacturing operations in Allendale, New Jersey and Mountain View, California.

Boissel reiterated the firm's intention to restart CATs29 in Europe in the first half of 2016.

Japan CMO search

In related news, TxCell COO Miguel Forte said the firm plans “to examine options for manufacturing in Asia, and specifically Japan​.”

Earlier this month TxCell said Ovasave was on the verge of being granted a key patent in Japan.

The patent, which is similar to those already granted in the US, Australia and Russia, covers the administration of a composition that consists of at least one human Type 1 Treg cell population directed against a food antigen from the common human diet.

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