The collaboration will leverage Kite’s experience in cell therapy manufacturing to co-develop and co-commercialise Arcellx’s lead candidate CART-ddBCMA, a BCMA-specific CAR-modified T-cell therapy for multiple myeloma
Kite and Arcellx enter into collaboration. (Credit: Michal Jarmoluk from Pixabay)
Kite, a biotechnology company of Gilead, has entered into a strategic collaboration with Arcellx to co-develop and co-commercialise the latter’s lead candidate, CART-ddBCMA.
CART-ddBCMA is a BCMA-specific CAR-modified T-cell therapy intended for the treatment of relapsed or refractory multiple myeloma.
Under the terms of the collaboration, Arcellx will receive an upfront cash payment of $225m and $100m equity investment as well as other potential contingent payments, at closing.
The companies will equally share development, clinical trial, and commercialisation costs for CART-ddBCMA and will jointly commercialise the product in the US.
Kite will market the product outside the US, with Arcellx receiving royalties on the sales.
The company will fund the development and commercialisation of any product under the collaboration that is not co-commercialised.
Once the technical transfer is completed, Kite will start manufacturing.
The transaction is expected to be closed in the first quarter of 2023, subject to Hart-Scott-Rodino Act, and other customary conditions.
Kite chief executive officer Christi Shaw said: “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.
“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 commercialisation to manufacturing, dedicated to the unique needs of this very complex field.”
Arcellx is a clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases.
The CART-ddBCMA is its investigational cell therapy product that contains autologous T cells that have been genetically modified to target multiple myeloma.
The drug leverages Arcellx’s novel D-Domain binder, which is a novel synthetic protein designed to bind specific therapeutic targets.
It is currently being developed in a Phase 2 clinical study, dubbed iMMagine-1.
CART-ddBCMA has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the US Food and Drug Administration.
Arcellx chairman and chief executive officer Rami Elghandour said: “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. The synergies between the two companies are a natural fit.
“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.”