CStone Biopharma Announces Joint Development Agreement with AstraZeneca for Novel GPC3 Armored CAR-T Therapy in China

December 7, 2023, Shanghai, China, Maryland, USA — Cellular Biomedicine Group (hereinafter referred to as “the Company” or “CBMG”), a global biopharmaceutical company at the clinical stage focused on the discovery and development of innovative cell therapies for oncology, inflammatory, and immune diseases, today announced a co-development agreement with AstraZeneca for C-CAR031. C-CAR031 is an armored CAR-T therapy targeting glypican-3 (GPC3) for hepatocellular carcinoma (HCC). C-CAR031 is based on AstraZeneca’s novel GPC3-targeted CAR-T (AZD5851), designed using AstraZeneca's dominant-negative transforming growth factor-β receptor II (TGFβRII) armored discovery platform and manufactured by CBMG in China.

Hepatocellular carcinoma (HCC) is one of the most common cancers in China and a major cause of cancer-related death in the country.¹, with 466,000 new cases annually, accounting for approximately 50% of the global total. About 45% of hepatocellular carcinoma (HCC) deaths worldwide occur in Greater China.²

Under the terms of the agreement, CBMG and AstraZeneca will co-develop and commercialize C-CAR031 in China, with CBMG receiving an upfront payment. CBMG is also eligible to receive milestone payments and global development royalties when AstraZeneca independently develops, manufactures, and commercializes AZD5851 outside of China.

At the 2023 Annual Meeting of the American Association for Cancer Research (AACR), the company presented an investigator-initiated trial (IIT) conducted in China, which preliminarily demonstrated the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) data of C-CAR031. The results showed that C-CAR031 exhibited promising anti-tumor activity and robust PK/PD characteristics in patients with advanced hepatocellular carcinoma.

"We are delighted to collaborate with AstraZeneca in developing innovative CAR-T therapies for the treatment of solid tumors," said Mr. Liu Bizuo, Chairman and Chief Executive Officer of Cellular Biomedicine Group. "The treatment of advanced hepatocellular carcinoma (HCC) has always been a significant challenge, and I believe that CAR-T therapy has the potential to redefine the treatment landscape for hepatocellular carcinoma (HCC) and other GPC3-expressing solid tumors."

Mark Cobbold, Global Vice President of AstraZeneca and Head of Cell Therapy in the Oncology R&D Department, stated: "This agreement with CBMG accelerates the research of AstraZeneca's innovative armored CAR-T platform in the field of solid tumors and advances our ambition to bring novel cell therapies to more patients with difficult-to-treat cancers."