T-knife GmbH, a next-gen adoptive T-cell company, and Catalent, have signed an agreement to provide technology transfer and CGMP clinical manufacturing of T-knife’s T1367 T-cell receptor (TCR) program.

T1367 is an autologous T-cell receptor-based cell therapy derived from T-knife’s proprietary humanized T-cell receptor (HuTCR) mouse platform and specifically targets MAGE-A1 positive tumors in cancer patients. The therapy is expected to be manufactured for clinical trials in both the EU and U.S.

Catalent will undertake transfer of T-knife′s platform process for T-cell receptor-based cell therapy at its site in Gosselies, Belgium, with the goal of manufacturing clinical batches for European trials in 2021. T-knife will also prepare for the transfer of the TCR manufacturing platform to Catalent’s Houston, TX, facility for clinical trials in North America in the future.

“The product candidates based on our proprietary HuTCR platform require sophisticated, state-of-the-art manufacturing capabilities and deep cell and gene therapy know-how,” said Michael Buchholz, Director Manufacturing of T-knife. “We are convinced that Catalent is the right partner for T-knife to ensure premier manufacturing of our pipeline programs, covering all stages from clinical trials to market.”

“Catalent is well-suited to support T-knife with focused technology transfer and process industrialization in both Gosselies and Houston,” commented Manja Boerman, Ph.D., President, Cell & Gene Therapy, Catalent. “Emerging and innovative treatments like T1367 are moving rapidly to the clinic. Catalent is committed to continual investment and expansion to support our clients as they continue on the journey to commercialization.”

Catalent’s 25,830 sq.-ft. facility in Gosselies, Belgium, provides clinical through commercial-scale cell therapy manufacturing, for both autologous and allogeneic cell therapy treatments. An additional large-scale commercial manufacturing plant is currently under construction at the site and expected to be fully commissioned in 2021. The company’s clinical manufacturing site in Houston is under qualification and expected to be fully commissioned in 2020.