Envafolimab is under clinical development by Alphamab Oncology and currently in the Phase I and Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Envafolimab’s likelihood of approval (LoA) and phase transition for Fibrosarcoma took place on 16 Dec 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway.

In addition, the same event on 16 Dec 2022 increased Envafolimab’s Phase Transition Success Rate (PTSR) for Pleomorphic Liposarcoma.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Envafolimab Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

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 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. The drug candidate is a fusion protein of anti-PD-L1 single domain antibody and Fc. It acts by targeting programmed cell death-ligand 1 (PD-L1) and it is developed based on dAb screening platform. The drug candidate acts by inhibiting PD-L1 and RTK. It was also under development for the treatment of hepatocellular carcinoma, sepsis and septic shock.

Alphamab Oncology overview

Alphamab Oncology (Alphamab) is a clinical-stage biopharmaceutical company.

Quick View Envafolimab LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Envafolimab
Administration Pathway
  • Subcutaneous
Therapeutic Areas
  • Infectious Disease
  • Oncology
Key Developers
Highest Development Stage
  • Marketed

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.