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Global pharmaceutical company, Kite, a Gilead Company, and clinical-stage biotechnology company Arcellx, announce a strategic collaboration to develop Arcellx’s late-stage candidate CAR-T-ddBCMA to treat patients with relapsed/refractory (r/r) multiple myeloma.
CAR-T-ddBCMA is built via the genetic modification of autologous T-cells utilizing Arcellx’s novel D-Domain binder. It is currently being investigated in a pivotal Phase II clinical trial, iMMagine-1, against r/r multiple myeloma in adult patients.
This lead product candidate has previously been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy designations by the FDA.
The partnership will see Arcellx receive an upfront payment of $225m from Kite, as well as a $100m equity investment. This transaction is expected to close in the first quarter of 2023.
The two companies will co-develop and co-commercialize CAR-T-ddBCMA, with costs for CAR-T-ddBCMA’s development, clinical trials, and, commercialisation to be shared jointly.
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Costs of CAR-T-ddBCMA’s clinical development , including the Phase II iMMagine-2 study, and any future clinical trials, as well as those for any other co-commercialized products, are to be shared 50/50 in the U.S., and 60/40 outside the U.S., by Kite and Arcellx respectively.
In the U.S., profits are set to be divided 50/50 between Kite and Arcellx for co-commercialized products including CAR-T-ddBCMA. All products not co-commercialized will be the responsibility of Kite – with Arcellx receiving royalties.
Outside of U.S territory, Kite will be responsible for the commercialization of CAR-T-ddBCMA, with Arcellx again receiving royalties.
“Combining our potentially best-in-class CART-ddBCMA therapy for multiple myeloma with Kite’s global leadership in cell therapy provides the foundation for us to commercialize our therapy at scale. Most importantly this collaboration is focused on accelerating access for patients in need,” comments Rami Elghandour, Arcellx’s Chairman and CEO.
“The collaboration with Arcellx enables Kite to expand into a new area of high unmet need and bring a potentially best-in-class cell therapy to help many patients. 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. The Kite team is excited to engage on this meaningful program in the multiple myeloma field, alongside Arcellx’s talented team,” adds Christi Shaw, Kite CEO.
Source: Arcellx Press Release
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