Aston Science Initiates Phase 2 Clinical Trial of Cancer Treatment Vaccine AST-301

Aston Science CI

[Asia Economy Reporter Lee Chun-hee] Aston Science is set to officially commence the multinational Phase 2 clinical trial of its plasmid DNA (pDNA) cancer treatment vaccine 'AST-301 (pNGVL3-ICD)'.

Aston Science announced on the 3rd that it received approval for the Phase 2 clinical trial plan (IND) for AST-301 from the Australian Therapeutic Goods Administration (TGA) on the 17th of last month, and has started the Phase 2 trial to verify the adjuvant treatment effect in high-risk post-surgery recurrence patients with HER2 low expression (HER2 +1 or +2) breast cancer.

This clinical trial is designed as a randomized study involving 146 patients. It is conducted to secure high reliability regarding safety and clinical efficacy through comparison with a placebo control group. Aston Science plans to expand the multinational trial beyond Australia to Taiwan and the United States in the second quarter of this year to include more cancer patients. Currently, pre-IND consultations with the U.S. Food and Drug Administration (FDA) have been completed, and IND preparation is underway in Taiwan.

According to the Phase 1 clinical trial results presented by Aston Science last year at the American Society of Clinical Oncology (ASCO) Annual Meeting, AST-301 has secured data on safety, immunogenicity, and survival rates from over 10 years of follow-up in breast cancer patients expressing HER2, and identified dosage groups applicable to late-stage clinical studies.

Accordingly, the Phase 2 CornerStone-001 study will administer three intradermal injections at the optimal dosage and evaluate the efficacy of AST-301 by setting the 2-year invasive disease-free survival (iDFS) as the primary endpoint, in combination with standard treatments for the patient group such as Xeloda or Keytruda.

Jung Eun-kyo, Chief Medical Officer (CMO) of Aston Science, stated, “This Phase 2 trial aims to achieve meaningful results in a clearer patient group across multiple countries including Australia, Taiwan, and the United States.”

Meanwhile, Aston Science is pursuing a KOSDAQ listing to support larger-scale new drug development. In May of last year, NH Investment & Securities was selected as the lead underwriter, and the company plans to apply for a technology evaluation in the second half of this year.

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