On November 3, 2025 Arcellx, Inc. (NASDAQ: ACLX), a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, reported it will share two presentations at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition taking place December 6-9, 2025, in Orlando, Florida, including updated clinical data from iMMagine-1, its Phase 2 pivotal study (publication #256) of anitocabtagene autoleucel (anito-cel) in patients with relapsed and/or refractory multiple myeloma (RRMM). Additionally, an abstract (publication #7644) describing the fast off-rate of anito-cel’s D-Domain binder will be published in a supplemental issue of Blood in November 2025. The company will also have a medical affairs booth (#1363) at the Orange County Convention Center.

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"We’re pleased to share that, along with our partners at Kite, we conducted our pre-BLA meeting with the FDA and remain confident in our planned 2026 commercial launch of anito-cel," said Rami Elghandour, Arcellx’s Chairman and Chief Executive Officer. "This milestone marks a significant step toward bringing our innovative therapy to the multiple myeloma community. We look forward to sharing updated clinical data from our iMMagine-1 study in an oral presentation at ASH (Free ASH Whitepaper). These are exciting times at Arcellx!"

ASH Presentation Details:

Title: Phase 2 registrational study of anitocabtagene autoleucel for the treatment of patients with relapsed and/or refractory multiple myeloma: Updated results from iMMagine-1
Speaker: Krina K. Patel, MD, MSc, MD Anderson Cancer Center
Session Name: 655. Multiple Myeloma: Cellular Therapies: Clinical Trial Advances in CAR T-Cell Therapy for Multiple Myeloma
Session Date: Saturday, December 6, 2025
Session Time: 2:00 p.m. – 3:30 p.m. ET
Presentation Time: 2:45 p.m. ET
Location: OCCC – West Hall E1
Publication Number: 256
Submission ID: abs25-4541

Title: Visualizing geographic variation and systemic inequities of disease burden and CAR T-cell therapy access in multiple myeloma in the US
Speaker: Brandon Blue, MD, Moffitt Cancer Center
Session Name: 907. Outcomes Research: Plasma Cell Disorders: Poster III
Session Date: Monday, December 8, 2025
Session Time: 6:00 p.m. – 8:00 p.m. ET
Location: OCCC – West Halls B3-B4
Publication Number: 6344
Submission ID: abs25-2093

Title: The fast off-rate of anito-cel’s D-Domain binder contributes to its distinctive pharmacology profile in preclinical models of multiple myeloma
Disposition: Online Publication
Publication Number: 7644
Submission ID: abs25-1695

About Multiple Myeloma
Multiple Myeloma (MM) is a type of hematological cancer in which diseased plasma cells proliferate and accumulate in the bone marrow, crowding out healthy blood cells and causing bone lesions, loss of bone density, and bone fractures. These abnormal plasma cells also produce excessive quantities of an abnormal immunoglobulin fragment, called a myeloma protein (M protein), causing kidney damage and impairing the patient’s immune function. MM is the third most common hematological malignancy in the United States and Europe, representing approximately 10% of all hematological cancer cases and 20% of deaths due to hematological malignancies. The median age of patients at diagnosis is 69 years with one-third of patients diagnosed at an age of at least 75 years. Because MM tends to afflict patients at an advanced stage of life, patients often have multiple co-morbidities and toxicities that can quickly escalate and become life-endangering.

About Anitocabtagene Autoleucel (anito-cel)
Anitocabtagene autoleucel (anito-cel, previously CART-ddBCMA) is the first BCMA-directed CAR T-cell therapy to be investigated in multiple myeloma that utilizes Arcellx’s novel and compact binder known as the D-Domain. The small, stable D-Domain binder enables high CAR expression without tonic signaling and is designed to quickly release from the BCMA target. This combination may allow for the effective elimination of multiple myeloma cells without severe immunotoxicity. Anito-cel has been granted Fast Track, Orphan Drug, and Regenerative Medicine Advanced Therapy Designations by the U.S. Food and Drug Administration.

(Press release, Arcellx, NOV 3, 2025, View Source [SID1234659308])