Shares of Arcellx (NASDAQ: ACLX) traded higher on Friday after reporting continued robust long-term responses from its CART-ddBCMA phase 1 expansion trial in patients with relapsed or refractory multiple myeloma.
Results of its CART-ddBCMA Phase 1 expansion trial, which showed continued long-term responses in patients with relapsed or refractory multiple myeloma. The company also announced that it has begun dosing patients in its iMMagine-1 Phase 2 clinical trial, and has initiated a Phase 1 clinical trial of ACLX-002 for the treatment of patients with relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndromes. As of October 31, 2022, 38 patients were evaluable for efficacy and safety analysis, and all of these patients showed poor prognostic factors. The interim results of the CART-ddBCMA Phase 1 trial demonstrate deep and durable responses in patients with poor prognostic factors, and the recommended Phase 2 dose was selected to be 115 (+/- 10) million CAR+T cells.
All 38 evaluable patients, with a median follow-up of 15 months, achieved an overall response rate according to the International Myeloma Working Group criteria. 27 of these patients (71%) achieved a complete response or stringent complete response, while 7 (18%) achieved a very good partial response. 4 (11%) achieved a partial response. 89% of patients achieved a response greater than very good partial response. 58% of patients had high-risk features, and 34% had extramedullary disease.
Matthew J. Frigault, M.D., CART-ddBCMA study investigator and Assistant Director of the Cellular Therapy Service at Mass General Cancer Center and Instructor at Harvard Medical School said, "CART-ddBCMA continues to demonstrate deep responses. It is encouraging to see these clinical results with an autologous cell therapy, particularly in a population with high-risk features. Accessibility to treat multiple myeloma patients with CAR-T therapy remains an issue."
CART-ddBCMA is a CAR-modified T-cell therapy being developed by Arcellx for the treatment of patients with relapsed or refractory multiple myeloma. It utilizes the company's proprietary binding domain technology to target BCMA. The therapy is currently in a Phase 2 study and has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy designations by the FDA.
The company will host a live webcast event with an expert panel of clinicians to discuss the clinical results on December 11, 2022. The event will be accessible on Arcellx's website and a replay will be available for 30 days after the event.
Arcellx, Inc. is a biotechnology company focused on developing cell therapies for cancer and other incurable diseases. The company's lead product candidate, CART-ddBCMA, is being developed for the treatment of relapsed or refractory multiple myeloma. It has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy designations by the FDA. Arcellx believes that cell therapies are a key part of medicine and its mission is to make cell therapies safer, more effective, and more widely available.
Shares of Arcellx trade on the NASDAQ under the symbol ACLX. For mroe information visit www.arcellx.com.
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