Gilead's Kite, Arcellx Ink Over $300M Collaboration Pact For Late-Stage Multiple Myeloma Candidate

  • Kite, a Gilead Sciences Inc company GILD, announced a global strategic collaboration to co-develop and co-commercialize Arcellx Inc's ACLX lead late-stage product candidate, CART-ddBCMA, for relapsed or refractory multiple myeloma. 
  • Kite and Arcellx will jointly advance the CART-ddBCMA asset.
  • Arcellx will receive an upfront payment of $225 million, a $100 million equity investment, and other potential contingent payments. 
  • The companies will share development, clinical trial, and commercialization costs for CART-ddBCMA and will jointly commercialize the product and split U.S. profits 50/50. 
  • Outside the U.S., Kite will commercialize the product.
  • Arcellx also announced interim CART-ddBCMA Phase 1 results (October 31, 2022 cutoff date), demonstrating deep and durable responses.
  • Of the 38 evaluable patients with a median follow-up of 15 months, a 100% overall response rate (ORR) was achieved in all patients. 
  • 27 of 38 (71%) evaluable patients achieved complete response (CR).
  • CART-ddBCMA continues to be well-tolerated, showing no tissue-targeted toxicities and no cases of delayed neurotoxicity events or parkinsonian symptoms.
  • The company also initiated a Phase 1 study evaluating the safety of ACLX-002 in adults with relapsed and/or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). 
  • The secondary objectives are to measure the anti-tumor activity and pharmacokinetics of both SparX-002 and ARC-T cells.
  • Price Action: ACLX shares are up 22.5% at $26.57 on the last check Friday.
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