Aston Sci. Receives IND Approval from U.S. FDA for Phase 2 Clinical Trial of the Therapeutic Cancer Vaccine AST-301 in Patients with HER2 1+/2+ Breast Cancer

- CornerStone-001(NCT05163223),the multiregionalclinical trial for breast cancer treatment,receivedU.S.FDA approval for Phase 2 trial following the approvals in Australia and the Taiwan region.

- As the same patient group and design of a pivotal study are adopted,a placebo-controlled randomized study has been conducted in an adjuvant treatment with standard treatment regimen.

SEOUL,South Korea,Sept. 5,2022 --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 U.S. Food and Drug Administration(FDA) for Phase 2 clinical trial of its main product,AST-301(HER2-hICD vaccine).

Accordingly,CornerStone-001(NCT05163223),aPhase 2 clinical trial of AST-301(pNGVL3-hICD) for treating HER2-1+/2+breast cancer,is anticipated to proceed smoothly in the U.S. 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 multiregionalclinical trial(MRCT)in which AST-301(study drug) is administered in combination with standard treatments,such as Capecitabineor Pembrolizumab,in patients with a high risk of recurrence following a curativesurgery.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's discretion.

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 earlyresults,pivotal cohort expansion to generate corroborative clinical data in Phase 2 clinical trial isexpected. Aston Sci. expects faster patient recruitment,subsequent to IND clearancein the U.S.,from the first site(University of Washington,PI: Mary L. (Nora) Disis,M.D.) opened upin the U.S.

Dr.Choi,Regulatory Affairs Director of Aston Sci.said,"It is a remarkable milestone that is definitely a leapforward for us in the cancer vaccine clinical development field.Based on the significant regulatory value ofthe Phase 1 clinical trial,including more than 10 years of long-term survival data,we have reinforced regulatory-required data which complies to the latest guidelines of therapeutic cancer vaccine,and the U.S. FDA has fully reviewed and approved it."

Eun Kyo Joung,Chief Medical Officer of Aston Sci.,pointed out the 'cancer survivorship'. Dr. Joung said,"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 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."