AST-301 is under clinical development by EpiThany and currently in Phase II for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer). According to GlobalData, Phase II drugs for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer) have a 45% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how AST-301’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

AST-301 overview

AST-301 is under development for the treatment of triple negative breast cancer (TNBC), human epidermal growth factor receptor 2 positive breast cancer (HER2+ breast cancer), advanced or metastatic salivary gland tumor with HER2 overexpression, gastric cancer. It is administered intradermally. The therapeutic candidate is a Th1 selective DNA plasmid based vaccine encoding epitope derived from the intracellular domain of HER2.

EpiThany overview

EpiThany is a tumor vaccine company that focuses on the development of novel vaccines for the treatment of cancer. The company conducts clinical programs to develop a multi-antigen vaccine for various therapeutic areas such as breast cancer, ovarian cancer, colorectal cancer, and others. It also develops anti-cancer immunotherapy for robust tumor-targeted T-cell immunity. It’s technology enables the targeting of a multitude of tumor antigens across various cancers driving Th1-selective immune responses. EpiThany is headquartered in Seattle, Washington, the US.

For a complete picture of AST-301’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 2 September 2023

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.