Arcellx shares soared in early trade after the clinical-stage biotechnology company announced a global strategic collaboration with Gilead Sciences’ Kite Pharma unit to co-develop and co-commercialize its late-stage product candidate, CART-dddBCMA, for the treatment of patients with relapsed or refractory multiple myeloma.
Multiple myeloma is an incurable disease for most patients and the need remains for effective, safe, and broadly accessible therapies.
Currently in Phase 2 clinical development, CART-ddBCMA is an investigational cell therapy product comprising autologous T cells that have been genetically modified to target multiple myeloma.
Arcellx told investors CART-ddBCMA utilizes its novel D-Domain binder. Kite and Arcellx will jointly advance the CART-ddBCMA asset, it added.
“This collaboration marks a significant achievement for the myeloma field and Arcellx,” Arcellx chairman and CEO Rami Elghandour said in a statement.
“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."
Arcellx to receive royalties in non-US sales
Upon closing, Arcellx said it will receive an upfront cash payment of $225 million and $100 million equity investment as well as other potential contingent payments.
The companies will share development, clinical trial, and commercialization costs for CART-ddBCMA and will jointly commercialize the product and split U.S. profits 50/50.
Outside the US, Kite will commercialize the product and Arcellx will receive royalties on sales.
Kite will be responsible for the development and commercialization costs for any product under the collaboration that is not co-commercialized. After completion of the technical transfer, Kite will be responsible for manufacturing.
“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,” Kite CEO Christi Shaw added.
“Cell therapy has proven it can change the way cancer is treated by creating a potentially curative therapy for an individual patient, engineered from their own t-cells. 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 transaction is expected to close in the first quarter of 2023.
Arcellx shares traded 28% higher in Friday late morning trade.
Contact the author at stephen.gunnion@proactiveinvestors.com