Aston Sci. Inc., a clinical stage biopharmaceutical company specializing in clinical development of therapeutic cancer vaccines, announced that it has obtained IND approval from the US Food and Drug Administration (FDA) for phase 2 clinical trial of its main product, AST-301(HER2-hICD vaccine).
Accordingly, CornerStone-001(NCT05163223), a phase 2 clinical trial of AST-301(pNGVL3-hICD) for treating HER2- 1+/2+ breast cancer, is anticipated to proceed smoothly in the US following Australia and the Taiwan region.
Aston Sci. has already confirmed the safety/tolerability, immunogenicity, and survival rate of AST-301 by presenting the phase 1 results(PI: Mary L. (Nora) Disis, M.D., University of Washington) including a follow-up study of more than 10 years on breast cancer patients with HER2 expression, at the American Society of Clinical Oncology (ASCO) last year. The therapeutic cancer vaccine is expected to play a major role in preventing cancer recurrence after surgery and treating advanced cancer as it causes few adverse reactions and maintains long-term immunological memory compared to existing anticancer treatments.
The phase 2 clinical trial of AST-301 adopts a placebo-controlled randomized design and is a multiregional clinical trial(MRCT) in which AST-301 (study drug) is administered in combination with standard treatments, such as Capecitabine or Pembrolizumab, in patients with a high risk of recurrence following a curative surgery. A total of 146 patients would be enrolled in the study and get 3 immunizations (every 3 weeks, intradermal injection), fully aligning with a standard treatment schedule, followed by a booster immunization based on the investigator
