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…
Aston Science, a cancer vaccine developer, has secured Fast Track designation from the FDA for its investigational HER2-targeted therapeutic vaccine AST-301. This designation, granted on October 12, aims to expedite the development of the vaccine for treating HER2-expressing gastric cancer. Aston Science has completed patient enrollment and dosing in its Phase 2 trial, with results expected in October.
The designation, granted approximately four months after AST-301 received orphan drug status, highlights the global competitiveness of Korean companies in cancer therapeutic vaccine development.
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