Pharma Focus Asia

Arcellx and Kite Continue Progress with Advances in Anito-Cel Multiple Myeloma Program

Friday, May 10, 2024

Arcellx, Inc. (NASDAQ: ACLX) and Kite, a Gilead Company (NASDAQ: GILD), have jointly announced significant operational advancements in their collaborative effort on the anitocabtagene autoleucel (anito-cel) program for multiple myeloma treatment. This innovative therapy, utilizing Arcellx's compact D-Domain binder, represents a breakthrough as the first BCMA CAR T therapy explored in multiple myeloma.

The focal point of these updates is the unveiling of the iMMagine-3 trial, a global Phase 3 randomized controlled clinical trial. Expected to commence in the latter half of this year, this trial aims to compare the efficacy and safety of anito-cel against the current standard of care (SOC) for patients with relapsed and/or refractory multiple myeloma (rrMM). These patients will have undergone one to three prior lines of therapy, including both an immunomodulatory drug (IMiD) and an anti-CD38 monoclonal antibody.

Manufacturing for this trial will take place at Kite's facility in Frederick, Maryland, following the successful technical transfer from a third-party manufacturing organization. Additionally, the Investigational New Drug (IND) application for anito-cel has received clearance from the U.S. Food and Drug Administration.

Rami Elghandour, Arcellx’s Chairman and CEO, emphasized the significance of the iMMagine-3 trial in addressing an unmet clinical need, particularly in patients who have been exposed to previous treatments. He highlighted the trial's ability to capture a substantial patient population and provide access to a unique segment of patients.

Kite, underscored the urgency of addressing the substantial unmet need in patients with relapsed and/or refractory multiple myeloma. She expressed confidence in leveraging Kite's manufacturing expertise to position anito-cel as a leading candidate in cell therapy.

The iMMagine-3 trial is designed to enroll approximately 450 adult patients across ~130 study sites globally. Patients randomized to the anito-cel arm will undergo a specific treatment regimen involving leukapheresis, optional bridging therapy, lymphodepleting chemotherapy, and infusion of anito-cel.

The primary endpoint of the trial is progression-free survival (PFS), with key secondary endpoints including complete response rate, minimal residual disease negativity, overall survival, and safety parameters.

The collaborative effort between Arcellx and Kite aims to co-develop and co-commercialize anito-cel for the treatment of relapsed or refractory multiple myeloma. Anito-cel's unique characteristics, including its novel D-Domain binder and regulatory designations, position it as a promising candidate in the treatment landscape.



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