Nelipepimut-S is under clinical development by SELLAS Life Sciences Group 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 Nelipepimut-S’s likelihood of approval (LoA) and phase transition for Triple-Negative Breast Cancer (TNBC) took place on 04 Mar 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

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

Nelipepimut-S overview

Nelipepimut-s (NeuVax) is under development for the treatment of gastric cancer, HER2 low expressing breast cancer, HER2+ breast cancer, triple negative breast cancer, and ductal carcinoma in situ. The drug candidate is administered as intradermal injection. It consists of the E75 peptide derived from human epidermal growth factor receptor 2 (HER2) combined with the immune adjuvant granulocyte macrophage colony stimulating factor (GM-CSF). The vaccine candidate was also under development for the treatment of prostate, ovarian and, pancreatic cancer.

SELLAS Life Sciences Group overview

SELLAS Life Sciences Group (SELLAS), formerly Galena Biopharma, develops novel cancer immunotherapeutics for multiple cancer treatments. Its pipeline product candidates include galinpepimut-S (GPS), a wilms tumor1 (WT1) protein-targeting synthetic heteroclitic epitope immunotherapeutic antigen used for the treatment of acute myeloid leukemia, ovarian cancer, malignant pleural mesothelioma, multiple myeloma and solid tumors; and Nelipepimut-S, a vaccine derived from the human epidermal growth factor 2 or HER2 protein for the prevention of breast cancer and gastric carcinomas. The company collaborates with Memorial Sloan Kettering Cancer Center (MSKCC), National cancer Institute (NCI) and The University of Texas M.D. Anderson Cancer Center (MDACC) for conducting clinical trials targeting multiple cancer indications. SELLAS is headquartered in New York City, New York, the US.

Quick View Nelipepimut-S LOA Data

Report Segments
  • Innovator
Drug Name
  • Nelipepimut-S
Administration Pathway
  • Intradermal
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Phase II

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.