Aston Science Receives Approval for Phase 2 Plan of Cancer Treatment Vaccine 'AST-301'

Aston Science, an R&D company specializing in anticancer vaccines, announced on the 15th that the Investigational New Drug (IND) approval for the Phase 2 clinical trial of the therapeutic cancer vaccine 'AST-301' for HER2-expressing gastric cancer patients in Taiwan has been completed.

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Named 'CornerStone-003,' this study is an early proof-of-concept trial targeting HER2-expressing gastric cancer patients who have completed standard adjuvant therapy. It is a randomized clinical trial to evaluate safety and immune efficacy, where participants receive AST-301 treatment either 3 or 6 times to assess the drug’s safety and immunological effects. Aston Science plans to subsequently determine the optimal dosing schedule and analyze the correlation between immunogenicity and clinical efficacy by evaluating disease-free survival (DFS) as a secondary endpoint.

AST-301 is a DNA-based cancer therapeutic vaccine encoding the HER-2 antigen. The indications are divided into breast cancer and gastric cancer, with clinical trials ongoing for each. The breast cancer trial, named 'CornerStone-001,' is being conducted in the United States, Australia, and Taiwan.

Regarding gastric cancer, which is the subject of the CornerStone-003 trial, it is explained that although this cancer type has a high incidence in Asia, there have been relatively few studies targeting HER2-expressing gastric cancer patients. While effective adjuvant therapies to prevent postoperative recurrence in high-risk patients are needed, treatment options are limited, making the introduction of new therapies urgent.

Jeong Eun-kyo, Chief Medical Officer (CMO) of Aston Science, stated, “Through this clinical trial, we expect to demonstrate the potential of AST-301 as a new treatment option for HER2-expressing gastric cancer and play an important role in expanding the scope of immunotherapy for gastric cancer.”

This content was produced with the assistance of AI translation services.