US FDA Approves Aston Sci.'s Phase 2 IND for Ovarian Cancer Vaccine, AST-201

2023-09-12

临床2期疫苗免疫疗法临床申请

A New Vaccine Approach for Ovarian Cancer Patients

SEOUL, South Korea, Sept. 12, 2023 /PRNewswire/ -- 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.

Media Contact:

Kevin KP Jang

Public Affairs Manager

[email protected]

http://astonsci.com/

SOURCE Aston Sci. Inc.

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