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

On December 7, 2023 AbelZeta Pharma, Inc. ("AbelZeta" or the "Company"), a global clinical-stage biopharmaceutical company focused on the discovery and development of innovative cell therapies for cancer, inflammatory and immunological diseases, reported 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) (Press release, AbelZeta, DEC 7, 2023, View Source [SID1234638228]). C-CAR031 is based on a novel GPC3-targeting CART (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.

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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 codevelopment 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 (Free AACR Whitepaper) 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.