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Successful GMP Production Process for UCART19

“It is very exciting to lead a novel allogeneic gene therapy platform at the critical time when a R&D concept is translated into a GMP clinical grade industrial product to be investigated in clinical studies”

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Cellectis (Paris:ALCLS) (NASDAQ:CLLS) (Alternext: ALCLS – Nasdaq: CLLS) today announced that a series of three production runs of UCART19, its lead TALEN® gene edited product candidate, was performed, confirming the implementation of Cellectis’ manufacturing process in GMP conditions.

The manufacturing process for Cellectis’ allogeneic CAR T-cell product line, Universal CARTs or UCARTs, yields frozen, off-the-shelf, allogeneic, engineered CAR T-cells. UCARTs are meant to be readily available CAR T-cells for a large patient population. The TALEN®-based gene editing (knock-out of the TCR-alpha and CD52 genes) is designed to suppress T-cell alloreactivity and confer resistance to alemtuzumab to the T-cells. This important milestone shows that UCARTs can be manufactured in GMP conditions. It also demonstrates the industrial production of UCART19, as well as the capacity of Cellectis’ pipeline of UCART product candidates to be manufactured for clinical investigations.

“It is very exciting to lead a novel allogeneic gene therapy platform at the critical time when a R&D concept is translated into a GMP clinical grade industrial product to be investigated in clinical studies,” said Arjan Roozen, Vice President, GMP Solutions and Manufacturing.

“Cellectis has reached a critical milestone both for the Company and our industry, creating new opportunities for patients. Historically, cell-based therapies have grown in the world of individual grafts. With TALEN®-based gene editing they have now started...


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