AbelZeta Regains Global Rights of C-CAR039 (Prizlon-cel) and Receives FDA Clearance of IND Application in Large B-cell Lymphoma

ROCKVILLE, Md. and SHANGHAI, Aug. 16, 2026 /PRNewswire/ -- AbelZeta Pharma, Inc. ("AbelZeta" or the "Company"), a global clinical-stage biopharmaceutical company focused on the discovery and development of innovative and proprietary cell-based therapeutic products, today announced that the Company received the U.S. Food and Drug Administration (FDA) clearance of IND application for C-CAR039, also known as Prizloncabtagene Autoleucel (Prizlon-cel), an anti-CD20/CD19 bispecific CAR-T, for the treatment of relapsed or refractory (r/r) Large B-cell Lymphoma (LBCL).

In July 2026, AbelZeta regained all development, regulatory, manufacturing, commercialization, out-licensing and other collaboration rights relating to C-CAR039. The Company is currently working with the FDA to finalize the protocols for clinical development in third- or later-line LBCL patients previously treated with CAR-T therapies and second-line LBCL patients that are CAR-T therapy treatment naïve.

The program is supported by encouraging long-term clinical data presented at European Society for Blood and Marrow Transplantation (EBMT) in March 2026. Results from 48 patients with r/r B-cell non-Hodgkin lymphoma (B-NHL) enrolled in the Company's early clinical trials in China demonstrated a favorable safety profile and deep and durable responses, with an overall response rate (ORR) of 91.5% and complete response (CR) rate of 85.1%. Median PFS was 60.1 months at a median follow-up of 53.9 months.

"We are pleased to welcome C-CAR039 back to our hematology malignancy portfolio," said Tony (Bizuo) Liu, Chairman and Chief Executive Officer of AbelZeta. "Clinical trial results to date have demonstrated the favorable safety and encouraging efficacy of C-CAR039 in r/r LBCL patients. We believe that it has potential to help patients who have been treated and relapsed with commercially approved CAR-T therapies. This population has significant unmet medical needs and C-CAR039 represents a solution. We will also explore the potential of C-CAR039 in early lines of LBCL. We remain confident about the potential of C-CAR039 and are fully committed to accelerating the global development of C-CAR039, leveraging our extensive expertise in cell therapy."

The registrational Phase II clinical trial of C-CAR039 for r/r LBCL in CAR-T therapy naïve patients in China is still ongoing.

About AbelZeta Pharma, Inc.
AbelZeta is a global clinical-stage biopharmaceutical company with centers of excellence in Rockville, Maryland and Shanghai. 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 hematological malignancies, inflammatory and immunological diseases and solid tumors. 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 Pharma, 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 Pharma, Inc.
+1 (240) 552 5870
[email protected]
www.abelzeta.com

SOURCE AbelZeta Pharma, Inc.