Kite, a Gilead Company, has announced its plans to collaborate with clinical-stage biotech, Arcellx, as part of a joint global strategy to co-develop and co-commercialise Arcellx’s lead late-stage product candidate, CART-ddBCMA, for patients with relapsed or refractory multiple myeloma (MM).
MM is a form of haematological cancer and is the third most common haematological malignancy in Europe and the US, and it accounts for an estimated 10% of all haematological cancer cases, with 20% of death caused by such malignancies.
The condition is incurable for most patients and there is still a substantial need for safe, effective and accessible treatments. Typically, MM affects older patients, with one-third of patients receiving a diagnosis at an age of at least 75 years old, which can often mean patients have multiple co-morbidities and toxicities that can rapidly become life-endangering.
Christi Shaw, chief executive officer of Kite, said: “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 organisation from R&D to commercialisation to manufacturing, dedicated to the unique needs of this very complex field.”
CART-ddBCMA is currently in phase 2 clinical development and is an investigational cell therapy product made up of autologous T-cells that have been genetically altered to target MM. CART-ddBCMA leverages Arcellx’s novel D-Domain binder. As part of the agreement between the companies, Kite and Arcellx will jointly advance the CART-ddBCMA asset.
Rami Elghandour, chairman and chief executive officer of Arcellx, commented: “Combining our potentially best-in-class CART-ddBCMA therapy for MM 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. The synergies between the two companies are a natural fit.”
Once the deal is finalised, Arcellx will be set to receive an upfront cash payment of $225m and $100m equity investment, alongside other potential contingent payments.
The companies will split development, clinical trial and commercialisation costs for CART-ddBCMA and will jointly commercialise the product, each taking 50% of US profits. Beyond the US, Kite will commercialise the product and Arcellx will receive royalties on sales.
Kite will assume responsibility for the development and commercialisation costs for any product under the collaboration that is not co-commercialised.
The deal is expected to be finalised in the first quarter of 2023.