Novartis puts contract manufacturing ambitions on display with deal to produce Carisma's cell therapy

It turns out Novartis has a taste for the contract manufacturing business. After inking a slate of pandemic production pacts last year, the Swiss pharma is back for another—and this time, it’s looking beyond COVID-19.

Novartis has penned an initial deal to manufacture Carisma Therapeutics’ HER2-targeted CAR-M cell therapy, which is currently in initial studies to treat solid tumors.

Under the deal, Carisma will begin transferring its manufacturing process to a Novartis Cell Therapy site in Morris Plains, New Jersey, “starting in the coming days,” Novartis said Thursday. The drug giant aims to kick off clinical manufacturing of the cell therapy candidate next year.

“As one of the world’s largest producers of medicines, Novartis can mobilize its manufacturing capacity in an efficient way on multiple fronts,” Anton Gerdenitsch, head of Novartis Technical Operations’ contract manufacturing organization, said in a statement.

Novartis says it will continue to lend its manufacturing muscle to other companies, adding that “[f]urther specifics will be disclosed when agreements are concluded.”

So far, the company’s contract manufacturing ambitions have focused squarely on COVID-19.

Last year, Novartis agreed to chip in on production of Pfizer and BioNTech’s mRNA-based vaccine Comirnaty, helping fill shots at sites in Switzerland and Slovenia. The company also signed an initial manufacturing agreement with German mRNA specialist CureVac last March, and it penned a deal in April to reserve active pharmaceutical ingredient capacity for Roche’s rheumatoid arthritis med Actemra in Singapore.

CAR-M therapies, meanwhile, aren’t all that different from CAR-T therapies such as Novartis’ cancer med Kymriah. For the manufacturing process, immune cells are extracted from patients, modified and then infused back in. Unlike CAR-T therapies, however, CAR-Ms are made of macrophages.

As Novartis revs up its contract manufacturing operations, the fate of its generics outfit Sandoz remains undecided. In October, the Swiss pharma kicked off a strategic review of the business unit, noting that all options were on the table, including retaining the business and a potential separation.

The generics unit has reportedly attracted several suitors so far, including Swedish-based investment group EQT and the Struengmann family of Germany.