Entolimod is under clinical development by Statera Biopharma and currently in Phase I for Radiation Toxicity (Radiation Sickness, Acute Radiation Syndrome). According to GlobalData, Phase I drugs for Radiation Toxicity (Radiation Sickness, Acute Radiation Syndrome) have a 79% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Entolimod’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.

Entolimod overview

Entolimod (CBLB-502) is under development for the treatment of acute radiation syndrome, colorectal cancer, uveal melanoma, non-small cell lung cancer, anal cancer, urothelial bladder cancer, acute and chronic neutropenia and anemia. The drug candidate is administered through intramuscular and subcutaneous routes. The drug candidate is a recombinant derivative of the bacterial protein flagellin that acts by targeting toll-like receptor 5 (TLR5). The drug candidate was also under development for the treatment of liver metastasis, squamous cell carcinoma of the nasopharynx, oropharynx, oral cavity, paranasal sinuses, larynx, hypopharynx and head and neck cancer squamous cell carcinoma. It is being developed based on AIMS: Advanced Immunomodulating Multi-receptor System platform.

Statera Biopharma overview

Statera Biopharma is a bio-pharmaceutical company. The company develops and commercializes drugs to treat cancer, orphan indications and protect healthy tissues from radiation and chemotherapy. It product includes entolimod, a recombinant protein that acts as an agonist of toll-like receptor that finds application in radiation mitigation, oncology immunotherapy, and vaccines. Statera Biopharma provides entolimod-oncology, CBLB612, SA-702 – vaccine adjuvant, mobilan, and CBL0137. The company clinical-stage drug candidates are used for the treatment of cancer and protection from lethal radiation. It’s products includes to develop using protectan technology and curaxin technology. The company operates in the US and Russia. Statera Biopharma is headquartered in Buffalo, New York, the US.

For a complete picture of Entolimod’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.