EP-301

- A New Vaccine Approach for Ovarian Cancer Patients Seoul, South Korea, Sept. 12, 2023 – Aston Sci. is proud to announce that it has received Phase 2 Clinical Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for its innovative cancer vaccine, AST-201, designed specifically for ovarian cancer. This milestone achievement, known as the CornerStone-004 program, marks a significant step forward in Aston Sci.’s fight against women’s cancers. Study Highlights and the Primary Objective: The study is a randomized controlled trial designed to assess the clinical efficacy and safety of the plasmid-based DNA vaccine AST-201 when administered alongside standard adjuvant chemotherapy (Paclitaxel/Carboplatin), for patients with newly diagnosed Stage III advanced ovarian cancer following surgical intervention. The primary objective of this study is to evaluate the clinical efficacy of AST-201 compared to a placebo, as measured by the progression-free survival (PFS) rate. Aston Sci.’s Pipeline Expansion: With this milestone, Aston Sci.’s pipeline has expanded to include two drug candidates in multinational Phase 2 clinical trials: AST-201 for ovarian cancer and AST-301 for breast and gastric cancer. This milestone underscores Aston Sci.’s position as a frontrunner in the field, with a total of four drugs in advanced clinical stages. Aston Sci. is currently conducting or planning four CornerStone clinical programs in the United States, Taiwan, Korea and Europe. A New Vaccine Approach for Ovarian Cancer Patients: "In a global environment where approved immunotherapies for ovarian cancer remain scarce, our dedicated efforts are focused on delivering a safer and more advanced treatment option for ovarian cancer patients. We are committed to sharing our results at the earliest opportunity," said Dr. Hun Jung, Head of R&D Division at Aston Sci. Inc. "We will expand clinical research across various indications and reaffirm our expertise in the field of cancer vaccine development." About Aston Sci. Inc. Aston Sci. Inc. is a clinical-stage biopharmaceutical company led by a team of global pharmaceutical experts. Specializing in innovative immunotherapies, including therapeutic cancer vaccines, Aston Sci. focuses on enhancing T-cell immune responses against specific antigens, triggering cancer cell apoptosis. Central to our mission is the Th-Vac® platform. This platform, grounded in immune informatics, facilitates continuous epitope discovery, serving as the cornerstone of our ongoing efforts in therapeutic vaccine development. Headquartered in Seoul, South Korea, with a U.S. office in Seattle, Washington, Aston Sci. is deeply committed to delivering advanced treatments and preventing cancer recurrence, ultimately striving for safer and more effective options for cancer patients worldwide.

Aston Sci. has secured approval from the TFDA (in Taiwan) for its investigational new drug (IND) application to commence a Phase 2 trial of AST-301. Named "CornerStone-003," this study is an early proof-of-concept study targeting patients with HER2-expressed gastric cancer who have completed standard adjuvant treatment. It is a randomized-control clinical trial designed to evaluate safety and immunologic efficacy of AST-301. Participants in the study will receive a total of three or six doses of AST-301 treatment. Aston Sci. will subsequently determine the optimal dosing schedule and analyze the correlation between immunogenicity and clinical efficacy by evaluating disease-free survival (DFS) as a secondary endpoint. Named "CornerStone-003," this study is an early proof-of-concept study targeting patients with HER2-expressed gastric cancer who have completed standard adjuvant treatment. It is a randomized-control clinical trial designed to evaluate safety and immunologic efficacy of AST-301. Participants in the study will receive a total of three or six doses of AST-301 treatment. Aston Sci. will subsequently determine the optimal dosing schedule and analyze the correlation between immunogenicity and clinical efficacy by evaluating disease-free survival (DFS) as a secondary endpoint. AST-301 is a DNA-based therapeutic cancer vaccine encoding the HER2 antigen. Aston Sci. is conducting separate clinical trials for breast cancer and gastric cancer as indications for AST-301. Currently, the CornerStone-001 study targeting breast cancer is underway in the United States, Australia, and Taiwan. AST-301 is a DNA-based therapeutic cancer vaccine encoding the HER2 antigen. Aston Sci. is conducting separate clinical trials for breast cancer and gastric cancer as indications for AST-301. Currently, the CornerStone-001 study targeting breast cancer is underway in the United States, Australia, and Taiwan. Gastric cancer, particularly HER2-expressed gastric cancer, has a high incidence rate in Asia, but there is a lack of studies specifically focused on this patient population. Effective adjuvant therapies to prevent recurrence after surgery are needed for high-risk patients, but there are limited treatment options. Therefore, the introduction of new therapies is urgently needed. Based on the observation that some gastric cancers respond to immune checkpoint inhibitors, Aston Sci. expects that novel immunotherapies like therapeutic cancer vaccines can contribute to improving patient survival. Gastric cancer, particularly HER2-expressed gastric cancer, has a high incidence rate in Asia, but there is a lack of studies specifically focused on this patient population. Effective adjuvant therapies to prevent recurrence after surgery are needed for high-risk patients, but there are limited treatment options. Therefore, the introduction of new therapies is urgently needed. Based on the observation that some gastric cancers respond to immune checkpoint inhibitors, Aston Sci. expects that novel immunotherapies like therapeutic cancer vaccines can contribute to improving patient survival. Eunkyo Joung, CMO of Aston Sci., stated, "Through this clinical trial, we hope to demonstrate the potential of AST-301 as a new treatment option for HER2-expressed gastric cancer and play an important role in expanding the scope of immunotherapy for gastric cancer." Eunkyo Joung, CMO of Aston Sci., stated, "Through this clinical trial, we hope to demonstrate the potential of AST-301 as a new treatment option for HER2-expressed gastric cancer and play an important role in expanding the scope of immunotherapy for gastric cancer."