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Novartis to Manufacture Carisma Therapeutics' Anti-HER2 CAR-Macrophage Therapy

NEW YORK – Novartis will manufacture Carisma Therapeutics' investigational CAR-macrophage cell therapies at its New Jersey-based facility under a new deal the companies announced last week.

Philadelphia-based Carisma will transfer the production of its HER2-targeted autologous CAR-M therapy, which is currently in Phase I clinical trials for HER2-overexpressing solid tumors, to Novartis' cell and gene therapy manufacturing facility in Morris Plains, New Jersey.

The firms will begin transferring the manufacturing process in the coming days, and then clinical manufacturing is slated to begin in 2023. In the deal, Novartis is acting as a contract manufacturing organization to Carisma via its Global Biotech Cooperations (GBTC) unit. The Swiss drugmaker has previously entered CMO deals with firms manufacturing mRNA-based COVID-19 vaccines, including BioNTech, but is now expanding into the oncology cell and gene therapy space.

"The Global Biotech Cooperations unit of Novartis is fully committed to collaborate with Carisma Therapeutics to bring their CAR-M cell therapy to patients by offering its proven state-of-the-art cell and gene production capabilities," Anton Gerdenitsch, technical operations head of CMO at Novartis, said in a statement. "As one of the world's largest producers of medicines, Novartis can mobilize its manufacturing capacity in an efficient way on multiple fronts."

The firms expect to share additional details once they've finalized their agreement.