GEN-1 is under clinical development by Imunon and currently in the 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 GEN-1’s likelihood of approval (LoA) and phase transition for Epithelial Ovarian Cancer took place on 23 Dec 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 GEN-1 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

GEN-1 overview

GEN-1 (EGEN-001) is under development for the treatment of epithelial ovarian cancer, glioblastoma multiforme (brain cancer), fallopian tube cancer, peritoneal cancer, high-grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma and mixed epithelial carcinoma. It is administered intraperitoneally. The therapeutic candidate comprises DNA plasmid encoding IL-12 p35 and p40 genes. It is developed based on the TheraPlas delivery technology, an IL-12 DNA nucleic acid plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein. It was also under development for colorectal cancer.

Imunon overview

Imunon, formerly Celsion is an oncology company with focus on developing portfolio of new cancer treatments, including directed chemotherapies, RNA and DNA based therapies and immunotherapies. The company develops drugs using its three platform technologies including Lysolipid Thermally Sensitive Liposomes (LTSL), TheraPlas and TheraSilence. Its lead product candidate ThermoDox is a proprietary form of doxorubicin based LTSL technology in Phase III clinical trial for the treatment of primary liver cancer. It is also developing a comprehensive pipeline of targeted therapeutic agents for cancer. Imunon is headquartered in Lawrenceville, New Jersey, the US.

Quick View GEN-1 LOA Data

Report Segments
  • Innovator
Drug Name
  • GEN-1
Administration Pathway
  • Intraperitoneal
Therapeutic Areas
  • Oncology
Key Developers
  • Sponsor Company: Imunon
  • Originator: EGEN
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.