The investigational cell therapy is Arcellx’s lead candidate for the treatment of patients who have a rare type of cancer, relapsed or refractory multiple myeloma (r/r MM).
Currently in Phase 2 clinical development, CART-ddBCMA comprises autologous T cells that have been genetically modified to target multiple myeloma. It utilizes Arcellx's novel binding domain. The cell therapy product candidate has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the US Food and Drug Administration (FDA).
Building on previous data cuts, including ASCO in June, the developer released data findings at the 64th ASH annual meeting demonstrating continued robust long-term responses from CART-ddBCMA, with deep and durable responses observed in patients with poor prognostic factors.
Regarding the terms of the agreement, Arcellx will receive, upon close of the deal, an upfront cash payment of $225m and $100m equity investment.
Both companies will share development, clinical trial, and commercialization costs for CART-ddBCMA and will jointly commercialize and split US profits 50/50.
Outside the US, Kite, the Gilead subsidiary, 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.
Significant achievement for the myeloma field
The partnership, said the two entities, is set to leverage expertise across both companies, including Kite's global cell therapy leadership and production capabilities. Kite’s cell therapy manufacturing network spans process development, vector manufacturing, clinical trial production and commercial product manufacturing.
"This collaboration marks a significant achievement for the myeloma field and Arcellx," said Rami Elghandour, Arcellx's CEO. "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.
"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," said Christi Shaw, CEO of Kite. "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.
Arcellx will continue independently progressing its development pipeline.
The company is also advancing its dosable and controllable CAR-T therapy, ARC-SparX, through two programs: a Phase 1 study of ACLX-001 for r/r MM, initiated in the second quarter of 2022; and a Phase 1 study of ACLX-002 in relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndrome, initiated in the fourth quarter of 2022.