AbelZeta Pharma Announces Agreement with AstraZeneca to Co-Develop a novel Glypican 3 (GPC3) Armored CAR-T Therapy in China

ROCKVILLE, Md. and SHANGHAI, Dec. 7, 2023 /PRNewswire/ -- AbelZeta Pharma Inc. (the Company, or AbelZeta), a global clinical-stage biopharmaceutical company focused on the discovery and development of innovative cell therapies for cancer, inflammatory and immunological diseases, today announced an agreement with AstraZeneca to co-develop C-CAR031, an autologous, armored GPC3-targeting chimeric antigen receptor T Cells (CAR-T) therapy, in hepatocellular carcinoma (HCC). C-CAR031 is based on a novel GPC3-targeting CAR-T (AZD5851) designed by AstraZeneca using their transforming growth factor-beta receptor II (TGFβRII) dominant negative armoring discovery platform, and is manufactured by AbelZeta in China.

HCC is one of the most common cancers and major causes of cancer deaths in China¹, with 466 thousand new cases each year, accounting for about 50% of the total global new cases. Approximately 45% of deaths worldwide from HCC occur in greater China.² 

Under the terms of the agreement, AbelZeta will receive an upfront payment from AstraZeneca for the co-development and commercialization of C-CAR031 in China. AbelZeta is also eligible to receive milestone payments and royalties for the global development of AZD5851, which is being solely developed, manufactured and commercialized by AstraZeneca outside of China.

At AACR 2023, the Company presented preliminary safety, efficacy, pharmacokinetics (PK) and pharmacodynamic (PD) data from an investigator-initiated trial (IIT) in China showing promising anti-tumor activity and robust PK/PD profiles for C-CAR031 in patients with advanced HCC.

"We are pleased to collaborate with AstraZeneca in pursuing this novel CAR-T treatment for solid tumors," said Tony (Bizuo) Liu, Chairman and CEO of AbelZeta. "The treatment of advanced HCC has always been a great challenge, and I believe this CAR-T therapy has the potential to redefine therapeutic paradigms in HCC and other GPC3-expressing solid tumors."

Mark Cobbold, Vice President, Head Cell Therapy, Oncology R&D, AstraZeneca said: "This agreement with AbelZeta accelerates the investigation of our innovative armoring CAR-T platform in solid tumors and advances our ambition to bring novel cell therapies to more people living with hard-to-treat cancers."

About HCC

Liver cancer is the third-leading cause of cancer death and the sixth most commonly diagnosed cancer worldwide.^3,4 Several types of primary liver cancer occur in adults, HCC being the most common form. About 75% of all primary liver cancers in adults are HCC.³ Liver cancers are categorized based on the originating cell type. Hepatocellular carcinoma begins in the liver as either a single tumor or several small nodules and at this local stage can be treated by locally targeted or surgical methods. However, most patients are diagnosed at advanced-stage, or their disease progresses to advanced-stage HCC when the prognosis is poor, with a 5-year survival rate of only 7% and a median survival of ~20 months.⁵

1. Chinese Clinical Oncology Vol 2, No 4 (December 16, 2013) 
2. Frontiers in Public Health doi: 10.3389/fpubh.2022.801981
3. ASCO. Liver Cancer: View All Pages. Available at: https://www.cancer.net/cancer-types/liver-cancer/view-all. Accessed November 2023.
4. WHO. Liver Cancer Fact Sheet. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/11-Liver-fact-sheet.pdf. Accessed November 2023.
5. NEJM Evid 2022;1(8) DOI: 10.1056/EVIDoa2100070 and N Engl J Med 2020; 382:1894-1905
   DOI: 10.1056/NEJMoa1915745

About AbelZeta Pharma, Inc.

AbelZeta Pharma is a global clinical-stage biopharmaceutical company with centers of excellence in Rockville, Maryland and Shanghai, China. The Company 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. The Company advances research and development in its own research and 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.
Phone: +1 (240) 552 5870
Email: [email protected]

SOURCE AbelZeta Pharma, Inc.