Sotigalimab is under clinical development by Apexigen 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 Sotigalimab’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.

Sotigalimab overview

Sotigalimab (APX-005M) is under development for the treatment of renal cell carcinoma, metastatic melanoma, recurrent or refractory primary malignant CNS tumors including newly diagnosed diffuse intrinsic pontine gliomas, anaplastic astrocytoma, pleomorphic sarcoma, liposarcoma, leiomyosarcoma, glioblastoma multiforme, gliosarcoma, anaplastic mixed glioma or fibrillary astrocytoma, metastatic pancreatic ductal adenocarcinoma, non-small cell lung cancer, squamous cell carcinoma, adenocarcinoma or undifferentiated carcinoma of the esophagus or GE junction, urothelial carcinoma, squamous cell carcinoma of the head and neck, rectal adenocarcinoma, epithelial ovarian, fallopian tube or primary peritoneal cancer and other solid tumors with high microsatellite instability status. The drug candidate is administered intravenously and intratumorally. APX-005 is a monoclonal antibody that acts as CD40 agonist. It is developed using a proprietary mutational lineage guided (MLG) humanization technology and APXiMAB discovery platform

It was under development for the treatment of non-small cell lung cancer and melanoma.

Apexigen overview

Apexigen is a clinical-stage biopharmaceutical company that discovers and develops antibody-based drugs for the treatment of cancer. The company’s lead immune oncology program APX005M, is a humanized monoclonal antibody that stimulates cancer specific T-cell responses. It also provides other immune oncology drug candidates that are in pre clinical stage of development. The company develops pipeline products using its APXiMAB, a proprietary antibody discovery platform. The company’s products include APX601, APX701 and APX201 of Internal Oncology Programs. The company works in strategic collaboration with various pharmaceutical companies to develop drugs for the treatment of cancer and inflammation, among others. Apexigen is headquartered in San Carlos, California, the US.

For a complete picture of Sotigalimab’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.