AbelZeta Receives FDA RMAT and Fast Track Designations for Prizlon-cel in Relapsed or Refractory Large B-Cell Lymphoma

• Dual designations support continued development of Prizlon-cel across multiple treatment settings in LBCL, including a potential accelerated approval path following prior CAR-T therapy and a randomized second-line development program

ROCKVILLE, Md., Nov. 10, 2026 /PRNewswire/ -- AbelZeta Inc. ("AbelZeta" or the "Company"), a cell therapy leader focused on discovering, developing and manufacturing therapeutics to address unmet medical needs in oncology and inflammatory and immunological diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted both Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations to Prizloncabtagene Autoleucel (Prizlon-cel), also known as A-CAR039, an investigational anti-CD20/CD19 bispecific CAR-T therapy for the treatment of patients with relapsed or refractory (r/r) large B-cell lymphoma (LBCL).

The designations were granted under AbelZeta's Investigational New Drug (IND) application (STN 32908) and support the Company's continued U.S. development of Prizlon-cel in r/r LBCL.

AbelZeta is pursuing a development strategy spanning both later-line patients previously treated with FDA-approved CAR T-cell therapies and patients treated earlier in the course of disease.

As part of the strategy, AbelZeta plans to evaluate Prizlon-cel in ABZT-121 (NCT07875413), a Phase 2 study in patients with r/r LBCL following treatment with an FDA-approved, commercially available CAR T-cell therapy. AbelZeta intends to evaluate whether results from ABZT-121 could support a potential accelerated-approval pathway in this population, subject to clinical results and future discussions with FDA. In parallel, the Company is developing ABZT-131, a randomized clinical study of Prizlon-cel in the second-line treatment of r/r LBCL. The study is intended to evaluate Prizlon-cel earlier in the treatment course and to further define its potential role relative to established CAR T-cell therapies. Together, ABZT-121 and ABZT-131 are intended to support a broader development strategy for Prizlon-cel across clinically important r/r LBCL treatment settings.

RMAT designation provides opportunities for intensive FDA interaction regarding clinical development, including discussions intended to support efficient development and potential approval. Fast Track designation is intended to facilitate development and expedite review of therapies for serious conditions with unmet medical need and may provide opportunities for more frequent FDA interactions and rolling review of portions of a future Biologics License Application (BLA), if applicable requirements are met.

"These dual FDA designations are important milestones for Prizlon-cel and support our strategy to develop it across multiple treatment settings in r/r LBCL," said Tony Liu, Chief Executive Officer of AbelZeta. "Our near-term development strategy includes patients whose disease has progressed  following prior CAR T-cell therapy, a population with substantial unmet medical need, while we are also preparing to evaluate Prizlon-cel earlier in the treatment course through a randomized second-line program. We look forward to working closely with the FDA as we advance both elements of this development strategy."

In July 2026, AbelZeta regained all global development, regulatory, manufacturing, commercialization and other collaboration rights relating to Prizlon-cel. In August 2026, the Company received FDA clearance of its IND application (STN 32908) to advance the U.S. clinical development of Prizlon-cel in r/r LBCL.

About AbelZeta Inc.
AbelZeta is a clinical-stage biopharmaceutical company based in Rockville, Maryland. AbelZeta is focusing on developing innovative and proprietary cell-based therapeutic products and is committed to ushering in bespoke treatments that harness the body's own immune system to fight against oncology and inflammatory and immunological diseases. AbelZeta advances research and development in its own GMP facilities at its centers of excellence, with a pipeline comprised of multiple CAR-T therapies.

Forward-Looking Statements
Statements in this communication relating to plans, strategies, specific activities, and other statements that are not descriptions of historical facts are forward-looking statements. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to numerous factors. Forward-looking statements are based on the current beliefs and management's expectations and are subject to significant risks and uncertainties outside of AbelZeta Inc.'s ("AbelZeta" or the "Company") control. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as otherwise required by law, AbelZeta does not undertake any obligation, and expressly disclaims any obligation, to update, alter or otherwise revise any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise.

Company Contact:
Sarah Kelly
Director of Communications
AbelZeta Inc.
+1 (240) 552 5870
[email protected]
www.abelzeta.com

SOURCE AbelZeta Inc.