Aston Sci. Receives IND Approval from FDA for Phase 2 Clinical Trial of Therapeutic Cancer Vaccine AST-301 in Patients with TNBC

- CornerStone-001, the multinational clinical trial for breast cancer treatment, received FDA approval for Phase 2 trial following the approvals in Australia and the Taiwan region.
- As the same patient group and design for Phase 3 clinical trials are adopted, Biologics License Application (BLA) submission may be discussed

SEOUL, South Korea, Sept. 1, 2022 /PRNewswire/ -- Aston Sci. Inc., a clinical stage biopharmaceutical company specializing in clinical development of therapeutic cancer vaccines, announced that it obtained IND approval from the U.S. Food and Drug Administration (FDA) for Phase 2 clinical trial of its main product, AST-301 (HER2-ICD vaccine). Accordingly, CornerStone-001, a multinational Phase 2 clinical trial of AST-301(pNGVL3-hICD) for treating HER2-low breast cancer, is anticipated to proceed smoothly in the U.S. following Australia and the Taiwan region.

Aston Sci. has already confirmed the safety in humans, immunogenicity, and survival rate of AST-301 by presenting the Phase 1 results 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 multinational clinical trial in which the investigational product (IP) is administered in combination with standard treatments, such as Xeloda or Keytruda, in patients with a high risk of recurrence following HER2-low breast cancer surgery.

It is also emphasized that the Phase 2 clinical trial adopts the same patient group and design as in Phase 3 clinical trials. Depending on the interim results, discussions of expedited authorization of BLA and pivotal cohort expansion to generate corroborative clinical data in Phase 2 clinical trial are expected. This is similar to the strategy used by MSD for prompt IND clearance using the results of the Keytruda Phase 1 clinical trial (KEYNOTE-001). Aston Sci. expects faster patient recruitment subsequent to IND clearance in the U.S.

Eunyoung Choi, Aston Sci.'s Regulatory Affairs (RA) Director, considered the successful transition to the Sponsor-Initiated Trial (SIT) without loss of Investigator-Initiated Trial (IIT) data to be one of the significant achievements of this IND approval. She also said, "It is an important step forward in the cancer vaccine market. Based on data from the Phase 1 clinical trial, including more than 10 years of long-term survival data, we have generated additional data which complies to the latest guidelines required for IND clearance, and the U.S. FDA has fully reviewed and approved it."

In closing, Eun Kyo Joung, Aston Sci.'s Chief Medical Officer (CMO), also pointed out the 'cancer survivorship' experienced by cancer survivors. The number of cancer survivors is rapidly increasing thanks to early cancer detection and advances in medical technology. According to 2018 statistical data, the number of fully recovered and surviving cancer patients in the past 5 years reached about 450,000 in Korea and about 44 million worldwide. Nevertheless, cancer survivors still suffer from physical and psychological pain during the period of survival and even after full recovery due to the side effects of chemotherapy, fear of recurrence, and social problems that must be faced throughout their  lives. We are confident that our therapeutic cancer vaccines will contribute to disease management, prevention of recurrence, and recovery of the overall quality of life for cancer survivors."

SOURCE Aston Sci. Inc.