CD19/CD20 CAR-T Cells

Amended worldwide collaboration and license agreement for CD20-directed chimeric antigen receptor T (CAR-T) C-CAR039 and C-CAR066 to include an option for commercialization of products in China ROCKVILLE, Md. and SHANGHAI, Dec. 14, 2023 /PRNewswire/ -- AbelZeta Pharma, Inc. ("AbelZeta" or the "Company"), a global clinical-stage biopharmaceutical company focused on discovery and development of innovative and proprietary cell-based therapeutic products, today announced an amendment of its worldwide collaboration and license agreement with Janssen Biotech, Inc. (Janssen), a Johnson & Johnson company. Under the amended agreement, Janssen will have the option to obtain exclusive commercialization rights in China for CD20-directed chimeric antigen receptor T (CAR-T) C-CAR039 and C-CAR066, which are being studied for the treatment of Non-Hodgkin Lymphoma (NHL). Continue Reading "As presented recently at the 65th ASH Annual Meeting, the clinical data for both C-CAR039 and C-CAR066 continue to support the potential of both assets to be best in disease in relapsed or refractory (r/r) NHL," said Tony (Bizuo) Liu, Chairman and CEO of the Company. "The Centre for Drug Evaluation in China has approved the Investigational New Drug (IND) application for C-CAR039, and we are currently conducting the Phase 1b study. We are excited to leverage AbelZeta's clinical development and product manufacturing capabilities together with Janssen's global commercialization expertise to maximize the potential of C-CAR039 and C-CAR066 to bring innovative and life-changing therapies to patients in China and worldwide." "The clinical data continues to support the potential of both assets to be best in disease in r/r NHL." Post this Under the terms of the agreement, Janssen will pay AbelZeta Pharma an option exercise fee, and AbelZeta Pharma is eligible to receive commercialization and sales milestones. About the Studies C-CAR039 is a novel bispecific CAR-T therapy targeting both CD19 and CD20 antigens and has received U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) clearance, and Regenerative Medicine Advanced Therapy and Fast Track designations for the treatment of patients with relapsed/refractory (r/r) diffuse large B-cell lymphoma (DLBCL). A Phase 1b study in the U.S. evaluating C-CAR039 in the treatment of patients with r/r DLBCL is underway. C-CAR066 is an optimized, novel CD20 targeted CAR-T therapy that has also received U.S. FDA IND clearance, and a Phase 1b study in patients with r/r DLBCL, including r/r to CD19 CAR-T treatment, is underway in the U.S. About NHL and DLBCL Non-Hodgkin Lymphoma (NHL) is the most common hematological, or blood malignancy worldwide. NHL ranked as the 5th to 9th most common cancer in most countries globally, with an estimated 544,000 new cancer cases and 260,000 cancer deaths in 2020.1 Diffuse large B-cell lymphoma (DLBCL) is a common and aggressive form of non-Hodgkin lymphoma that accounts for one out of every three cases of NHL. Despite available frontline treatment, many patients will experience a relapse or have refractory (resistant to treatment) disease, for which there are limited treatment options and a high risk of mortality. For patients who relapse or do not respond to initial therapies, conventional treatment options that provide durable remission are limited and median life expectancy is about six months, leaving a critical need for new therapies.2,3 Mafra A, Laversanne M, Gospodarowicz M, Klinger P, De Paula Silva N, Piñeros M, Steliarova-Foucher E, Bray F, Znaor A. Global patterns of non-Hodgkin lymphoma in 2020. Int J Cancer. 2022 Nov 1;151(9):1474-1481. doi: 10.1002/ijc.34163. Epub 2022 Jul 2. PMID: 35695282. Crump M, Neelapu SS, Farooq U et al. Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study. Blood. 2017; 130(16): 1800-1808. Raut LS, Chakrabarti PP. Management of relapsed-refractory diffuse large B cell lymphoma. South Asian J Can. 2014; 3(1): 66-70. About AbelZeta Pharma, Inc. AbelZeta is a global clinical-stage biopharmaceutical company with centers of excellence in Rockville, Maryland and Shanghai, China. 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 and solid tumors, as well as inflammatory and immunological diseases. AbelZeta advances research and development in its own GMP facilities at its centers of excellence for early-stage clinical studies, with a pipeline comprised of CAR-T and TIL 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 a number of factors, which include any risks detailed from time to time in the Company's reports. Such statements are based on the management's current beliefs and expectations and are subject to significant risks and uncertainties outside of management and the Company's 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, the Company 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] SOURCE AbelZeta Pharma, Inc.