Gilead lands new cell therapy for Kite in $225M Arcellx deal, providing global scale for future J&J-Legend showdown

Gilead Sciences has landed its Kite unit at Arcellx to work on a phase 2 multiple myeloma cell therapy in a deal worth $225 million upfront. The biotech will gain global scale as it gears up for a future showdown against an already approved med from healthcare behemoth Johnson & Johnson and its partner Legend Biotech.

The two companies will work on Arcellx’s lead asset called CART-ddBCM, which is for relapsed or refractory multiple myeloma. The deal marks an expansion into a new area for Kite, Gilead’s cell therapy unit that has produced approved treatments Yescarta and Tecartus.

Arcellx is trying to go up against Johnson & Johnson and Legend’s Carvykti, which in February got a nod to treat multiple myeloma after four previous therapies. That’s a tough hill to climb for a small, clinical-stage biotech, so having Gilead's could be crucial to CART-ddBCM's success.

Kite will bring expertise from its two approved cell therapies, the unit’s CEO Christi Shaw noted in the press release. Arcellx will benefit from a larger company that has the scale to commercialize CART-ddBCM.

“To deliver cell therapy globally and at scale, it requires a highly coordinated, vertically integrated organization from R&D to commercialization to manufacturing, dedicated to the unique needs of this very complex field,” Shaw said.

CART-ddBCM is a BCMA-specific CAR-modified T-cell therapy being tested in a phase 2 study called iMMagine-1. The therapy already has a handful of designations—fast track, orphan drug and regenerative medicine advanced therapy—from the FDA that give it a boost through the clinical and regulatory processes.

The deal includes a $100 million equity investment. The companies will share development, clinical trial and commercialization costs for the therapy and jointly commercialize it, splitting profits 50/50. Kite will commercialize CART-ddBCM outside the U.S. and Arcellx will receive royalties. Kite will eventually take over manufacturing duties once the tech transfer is complete. The deal is expected to close in the first quarter of 2023.

In June, Maryland-based Arcellx presented phase 1 multiple myeloma data at the 2022 American Society of Clinical Oncology annual meeting, showing that CART-ddBCM spurred a 100% overall response rate after a median follow-up of 12.1 months, and 71% of those patients achieved a complete response or better.

The Arcellx deal was not Gilead’s only move on Friday. The California pharma also signed a collaboration with ImmunoGen to work on the CD47 inhibitor pivekimab sunirine in a type of advanced acute myeloid leukemia. Financial details were not disclosed, but the partnership will see the advancement of a new cohort in ImmunoGen's existing phase 1b/2 802 study. The trial is testing pivekimab sunirine in combination with Bristol Myers Squibb’s Vidaza and/or AbbVie and Genentech’s Venclexta.