- dragona Gilead Sciences Inc company GILDannounced a global strategic cooperation to develop and market together Arcellx Inc ACLX lead late-stage product candidate, CART-ddBCMA, for relapsed or refractory multiple myeloma.
- Kite and Arcellx will jointly develop the CART-ddBCMA asset.
- Arcellx will receive a $225 million upfront payment, a $100 million equity investment and other potential contingent payments.
- The companies will share development, clinical testing and commercialization costs for CART-ddBCMA and will jointly commercialize the product and share US profits 50/50.
- Outside the US, Kite will commercialize the product.
- Arcellx also announced preliminary CART-ddBCMA phase 1 results (cut-off October 31, 2022) demonstrating this deep and lasting answers.
- Of the 38 evaluable patients with a median follow-up of 15 months, all patients achieved an overall response rate (ORR) of 100%.
- Twenty-seven of 38 (71%) evaluable patients achieved a complete response (CR).
- CART-ddBCMA remains well tolerated with no tissue-specific toxicities and no cases of delayed neurotoxic events or parkinsonian symptoms.
- The Company also initiated a Phase 1 study to evaluate the safety of ACLX-002 in adults with high-risk relapsed and/or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
- The secondary objectives are to measure the antitumor activity and pharmacokinetics of both SparX-002 and ARC-T cells.
- price action: ACLX shares are up 22.5% to $26.57 on the last check Friday.
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