Gotistobart is under clinical development by OncoC4 and currently in Phase II for Adenoid Cystic Carcinoma (ACC). According to GlobalData, Phase II drugs for Adenoid Cystic Carcinoma (ACC) does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Gotistobart LoA Report. 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.

Gotistobart overview

ONC-392 is under development for the treatment of metastatic solid tumors like malignant melanoma, renal cell carcinoma, hepatocellular carcinoma, pancreatic cancer, triple negative breast cancer, non-small cell lung cancer, head and neck carcinoma, gastric carcinoma, ovarian carcinoma, cervical cancer, colorectal cancer, sarcoma, peritoneal cancer, fallopian tube cancer, adenoid cystic carcinoma, esophageal cancer, anal canal cancer, metastatic castration-resistant prostate cancer (mCRPC) and unspecified indication. The drug candidate is a monoclonal antibody. It is administered through intravenous route. It acts by targeting cytotoxic T-lymphocyte-associated protein 4 (CTLA-4).

It was also under development for the treatment of Merkel cell carcinoma.

OncoC4 overview

OncoC4 is a clinical-stage biopharmaceutical company that discovers and develops novel biologicals to treat cancer. It is developing biologics for treating various cancers including hepatocellular carcinoma, breast cancer, ovarian cancer, cervical cancer, neuroblastoma, prostate cancer, lung cancer, and malignant brain tumors. The company’s lead pipeline product candidate ONC-392, a humanized IgG1 monoclonal antibody enables CTLA-4 to maintain its protective function against autoimmune diseases while enhancing anti-tumor activity. It is also investigating other drug programs including ONC-781, ONC-782, ONC-783, ONC-784, ONC-841 and ONC-895. OncoC4 is headquartered in Rockville, Maryland, the US.

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

This content was updated on 10 June 2024

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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.