Aston Science, a clinical-stage cancer vaccine developer, announced on October 12 that the U.S. Food and Drug Administration (FDA) had granted Fast Track designation to AST-301, its investigational HER2-targeted cancer therapeutic vaccine, for the treatment of HER2-expressing gastric cancer. The designation comes approximately four months after AST-301 received orphan drug designation in June.
Fast Track is designed to facilitate the development of medicines for serious conditions with unmet medical needs. It supports more frequent meetings and written communication with the FDA during development. It also provides an opportunity for rolling review, allowing completed sections of a marketing application to be submitted for review as they become available. A Fast Track product may also qualify for priority review or accelerated approval if the relevant criteria are met, potentially shortening the path to commercialization.
AST-301 is a plasmid DNA-based cancer therapeutic vaccine that uses the intracellular domain (ICD) of HER2 as its antigen. The investigational immunotherapy is designed to induce HER2-specific T-cell responses to eliminate cancer cells. Aston Science has completed patient enrollment and AST-301 dosing in its Phase 2 trial involving patients with HER2-expressing gastric cancer and is continuing to monitor outcomes. The company expects to announce results for key endpoints in October.
According to Aston Science, HER2-expressing gastric cancer accounts for more than 35% of all gastric cancer cases and is associated with a relatively poor prognosis. The company said this underscores demand for new treatments using immunological approaches such as AST-301.
“The successive orphan drug and Fast Track designations for AST-301’s gastric cancer indication demonstrate the global competitiveness of a Korean company in the regulatory development of cancer therapeutic vaccines,” said Eunyoung Choi, head of regulatory affairs at Aston Science. “They also recognize AST-301’s development potential as a treatment that could address unmet medical needs in HER2-expressing gastric cancer.”
Following the Fast Track designation, Aston Science plans to accelerate AST-301’s subsequent clinical development program through closer and more timely engagement with the FDA. The company will also consider pursuing an Early Access Program (EAP) in the United States. “Our goal is to advance toward the submission of a Biologics License Application (BLA),” a company representative said.
