Aston Science Cancer Treatment Vaccine 'AST-301' Receives Phase 2 IND Approval in Taiwan Following Australia

[Asia Economy Reporter Lee Chun-hee] Aston Science announced on the 10th that its cancer treatment vaccine under development, 'AST-301,' has received approval for a Phase 2 clinical trial plan (IND) from the Taiwan Food and Drug Administration (TFDA). Following the approval from the Australian Therapeutic Goods Administration (TGA) in February, this is the company's second IND approval. The company plans to accelerate multinational clinical trials through approval from the U.S. Food and Drug Administration (FDA) in the second half of this year.

AST-301 is a DNA-based cancer treatment vaccine encoding the human epidermal growth factor receptor-2 (HER-2) antigen. In the previous Phase 1 clinical trial, long-term safety was confirmed through a 10-year patient follow-up, and immune responses to the vaccine were maintained in most patients up to one year after the last administration.

Clinical trials for AST-301 are being conducted separately for breast cancer and gastric cancer indications. The current Phase 2 trials in Australia, Taiwan, and the United States target breast cancer as the indication. These randomized trials are being conducted as multinational studies considering conditional biological license application (BLA) approval. The trials target patients with low HER2 expression and hormone receptor-negative status who, after neoadjuvant chemotherapy, have not achieved pathological complete response and have residual tumors.

Although breast cancer treatment has continuously advanced recently, the recurrence rate remains relatively high in this patient group. This clinical trial aims to verify whether the 2-year disease-free survival rate improves when AST-301 is administered alongside standard adjuvant therapy during this period.

Jeong Eun-kyo, Chief Medical Officer (CMO) of Aston Science, said, "The multinational clinical trial of AST-301 is progressing smoothly. AST-301 is expected to reduce recurrence rates by maintaining long-term efficacy without significant side effects when administered in combination with standard therapy in relatively early-stage cancer patients,” he said.

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