Gemogenovatucel-T is under clinical development by Gradalis and currently in the Phase I, Phase II and Phase III 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 Gemogenovatucel-T’s likelihood of approval (LoA) and phase transition for Metastatic Melanoma took place on 23 Dec 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway.

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

Gemogenovatucel-T overview

Gemogenovatucel-T (Vigil) is under development for the treatment of solid tumors including Ewing sarcoma, uterine cancer, cervical cancer, endometrioid cancer, ovarian cancer, fallopian tube cancer or primary peritoneal cancer, non-small cell lung cancer, primitive neuroectodermal tumor, thyroid cancer, metastatic melanoma, hepatocellular carcinoma and colorectal cancer. The vaccine candidate is administered intradermally. The immunotherapy consists of autologous cells expressing rhGMCSF and bi-shRNAfurin from the FANG plasmid.

It was also under development for the treatment of Ewing sarcoma, uterine cancer, cervical cancer, neuroendocrine tumors, colorectal cancer with liver metastases and triple negative breast cancer.

Gradalis overview

Gradalis formerly Murex Pharmaceuticals is a biotechnology company that develops and commercializes novel therapies for the treatment of cancer. The company’s product pipeline includes autologous cancer vaccines, IO combinations and genes proteins for treating Ewing’s sarcoma, ovarian, breast, melanoma, solid tumors, lung, hepatocellular and colorectal cancer. Its proprietary immunotherapy platform, vigil is utilized in various advanced cancer indications and helps in stimulating and improving the body’s natural mechanism for identifying and killing cancer cells. Gradalis is headquartered in Carrollton, Texas, the US.

Quick View Gemogenovatucel-T LOA Data

Report Segments
  • Innovator
Drug Name
  • Gemogenovatucel-T
Administration Pathway
  • Intradermal
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Phase III

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.