Kite, a Gilead Company, and Arcellx have announced the closing of their collaboration agreement to jointly develop and commercialise Arcellx’s late-stage candidate to treat relapsed or refractory multiple myeloma.
As the third most common haematological malignancy – cancer that begins in blood-forming tissue – in Europe and the US, multiple myeloma represents approximately 10% of all haematological cancer cases and 20% of deaths caused by such malignancies.
The disease is incurable for most patients, underscoring the need for new treatment options to help improve long-term outcomes.
Currently in phase 2 clinical development, Arcellx’s CART-ddBCMA is an investigational cell therapy product using patients’ own T-cells that have been genetically altered to target the disease.
The candidate has already been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy designations by the US Food and Drug Administration.
“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,” Kite’s chief executive officer, Christ Shaw, explained at the time of the original announcement.
“To deliver cell therapy globally, and at scale, it requires a highly coordinated, vertically integrated organisation from R&D to commercialisation to manufacturing, dedicated to the unique needs of this very complex field,” Shaw added.
Announced in December 2022, the terms of the agreement stated Arcellx would receive an upfront cash payment of $225m and $100m equity investment, alongside other potential contingent payments.
The partners will split development, clinical trial and commercialisation costs for CART-ddBCMA and will jointly commercialise the product, each taking 50% of US profits.
Outside the US, Kite will commercialise the product and Arcellx will receive royalties on sales, with Kite assuming responsibility for the costs involved for any product under the collaboration that is not co-commercialised.
Rami Elghandour, chairman and chief executive officer of Arcellx, said at the time: “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 commercialise our therapy at scale.
“Most importantly, this collaboration is focused on accelerating access for patients in need… We both bring complementary expertise to the collaboration allowing each company to contribute to the partnership without duplication or competing interests, which is critical for building long-term value.”