Envafolimab is under clinical development by TRACON Pharmaceuticals and currently in Phase II for Pleomorphic Liposarcoma. According to GlobalData, Phase II drugs for Pleomorphic Liposarcoma 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 Envafolimab 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.

Envafolimab overview

Envafolimab (Enweida) is a recombinant humanized single domain antibody against programmed death ligand 1 (“PD-L1”) fused with human Fc. It is formulated as solution for subcutaneous route of administration. Enweida is indicated for the treatment of adult patients with advanced solid tumors who have unresectable or metastatic advanced microsatellite instability-high (MSI-H) phenotype/mismatch-repair deficiency (“dMMR”), including those patients with advanced colorectal cancer who have experienced disease progression after previous therapy with fluorouracil, oxaliplatin and irinotecan, as well as other patients with advanced solid tumors who have experienced disease progression after previous therapy and no satisfactory treatment alternatives.

Envafolimab (KN-035) is under development for the treatment of sepsis and septic shock, advanced or metastatic undifferentiated pleomorphic sarcoma, myxofibrosarcoma, metastatic melanoma, metastatic prostate cancer, metastatic breast cancer, non-small cell lung cancer, liver cancer, hepatocellular carcinoma, small-cell lung cancer, soft tissue sarcoma, head and neck cancer, vulvar cancer, neuroendocrine tumors, salivary gland cancer, thyroid papillary or follicular cancer, skin squamous cell carcinoma, skin malignant melanoma , Merkel cell tumor, head and neck squamous cell carcinoma, bladder cancer, cervical cancer, gastrointestinal tract cancer, gastro-esophageal junction adenocarcinoma, metastatic gallbladder cancer, renal cell carcinoma, metastatic cholangiocarcinoma, metastatic pancreatic cancer, metastatic ovarian cancer, MSS endometrial cancer, colon cancer, leiomyosarcoma, urothelial carcinoma, metastatic solid tumors, gastric cancer, hepatitis B and human immunodeficiency virus (HIV) infections (AIDS). It is administered through subcutaneous injection. It was also under development for the treatment of hepatocellular carcinoma.

TRACON Pharmaceuticals overview

TRACON Pharmaceuticals (TRACON) is a biopharmaceutical company. It develops and commercializes targeted therapies for cancer, age-related macular degeneration and fibrotic diseases. The company offers pipeline products such as TRC102 is an anti-endoglin antibody that is being developed for the treatment of multiple solid tumor types in combination with VEGF inhibitors. TRC102 is a small molecule that is in clinical development for the treatment of lung cancer and glioblastoma. It also offers products for the treatment of prostate cancer, and hematologic malignancies such as myeloma. The company works in collaboration with universities and medical institutions. TRACON is headquartered in San Diego, California, the US.

For a complete picture of Envafolimab’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.