AMV-564 is under clinical development by Amphivena Therapeutics and currently in Phase I for Solid Tumor. According to GlobalData, Phase I drugs for Solid Tumor have a 54% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how AMV-564’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.

AMV-564 overview

AMV-564 is under development for the treatment of relapsed or refractory acute myeloid leukemia, myelodysplastic syndrome and solid tumors including adenocarcinoma of the gastroesophageal junction, endometrial cancer, rectal cancer, penile cancer, transitional cell cancer (urothelial cell cancer), squamous cell carcinoma and non-small cell lung cancer. The drug candidate is a CD33/CD3 tetravalent bi-specific tandem antibody which comprises of two VH and Vl amino acid chains that form four antigen-binding single-chain variable fragment. It is administered through the intravenous and subcutaneous routes. The drug candidate based on TandAb technology, a bi-specific antibody platform designed for immune therapy of cancer.

Amphivena Therapeutics overview

Amphivena Therapeutics is a clinical-stage, immuno-oncology company. The company is developing a novel platform of dual-function biologics that relieve immune suppression and drive T-cell activation and polarization to restore anti-cancer immunity in patients. The company is headquartered in South San Francisco, California, the US.

For a complete picture of AMV-564’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.