Kite and Arcellx Advance Anito-Cel Multiple Myeloma Program

Kite, a Gilead Company, and Arcellx, Inc. have announced significant updates regarding their collaborative anitocabtagene autoleucel (anito-cel) multiple myeloma program. Anito-cel is the first BCMA CAR T therapy in multiple myeloma to employ Arcellx's innovative and compact D-Domain binder.

The companies have revealed the structure of an upcoming global Phase 3 clinical trial named iMMagine-3. Scheduled to commence in the latter half of this year, this trial aims to assess the efficacy and safety of anito-cel compared to the standard of care (SOC) in patients with relapsed and/or refractory multiple myeloma (rrMM) who have undergone one to three prior treatment lines, including an immunomodulatory drug (IMiD) and an anti-CD38 monoclonal antibody.

Kite's manufacturing facility in Frederick, Maryland, will produce anito-cel for the iMMagine-3 trial, following the successful technical transfer from a third-party manufacturer. This transfer includes the Investigational New Drug (IND) application for anito-cel, which has received clearance from the U.S. Food and Drug Administration.

Cindy Perettie, Executive Vice President of Kite, emphasized the importance of the Phase 3 iMMagine-3 trial, highlighting the unmet needs of patients with rrMM. Perettie underscored Kite's commitment to leveraging their manufacturing expertise to ensure high-quality, reliable, and swift cell therapy production, which is crucial for patients.

Rami Elghandour, Arcellx's Chairman and CEO, stated that the iMMagine-3 trial would assess anito-cel as a second to fourth line treatment in multiple myeloma patients previously exposed to both an immunomodulatory drug and an anti-CD38 monoclonal antibody. He noted that the trial is designed to meet the emerging clinical needs of these patients, particularly as anti-CD38 therapies advance to frontline treatment. Elghandour also highlighted the strategic benefits of the completed technical transfer to Kite, which accelerates the global launch of iMMagine-3 and broadens patient access to anito-cel.

The iMMagine-3 trial will involve around 450 adult patients, using various SOC regimens decided by investigators. The trial's primary endpoint is progression-free survival (PFS), evaluated by a blinded independent review according to the 2016 IMWG criteria for multiple myeloma. Key secondary endpoints include complete response rate, minimal residual disease negativity, overall survival, and safety.

The trial is set to begin in the second half of 2024 across approximately 130 study sites worldwide, including North America and Europe.

Arcellx and Kite's collaboration involves co-developing and co-commercializing anito-cel for multiple myeloma. While both companies will manage the U.S. market together, Kite will handle commercialization outside the United States.

Anito-cel, a BCMA CAR T therapy, employs a novel D-Domain CAR binder, which facilitates high T-cell transduction and expression. The U.S. FDA has granted anito-cel Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy designations.

Kite, based in Santa Monica, California, is a leader in cell therapy aimed at treating and potentially curing cancer. The company boasts the largest in-house cell therapy manufacturing network globally.

Gilead Sciences, Inc., Kite's parent company, is a biopharmaceutical firm that has achieved significant medical advances over three decades, focusing on life-threatening diseases including HIV, viral hepatitis, and cancer. Gilead, which acquired Kite in 2017, operates in over 35 countries with headquarters in Foster City, California.

Arcellx, Inc., headquartered in Redwood City, California, is a biotechnology company dedicated to developing innovative cell therapies for cancer and other incurable diseases. Anito-cel, Arcellx's leading product candidate, is currently in a pivotal Phase 2 trial for rrMM. Arcellx is also advancing its ARC-SparX CAR T therapy through Phase 1 trials for rrMM and acute myeloid leukemia.

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