Hepcortespenlisimut-L is under clinical development by Immunitor and currently in the 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 Hepcortespenlisimut-L’s likelihood of approval (LoA) and phase transition for Hepatocellular Carcinoma took place on 01 Sep 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 Hepcortespenlisimut-L Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Hepcortespenlisimut-L overview

Hepcortespenlisimut-L (V5) is under development for the treatment of hepatocellular carcinoma. V5 is adjunct oral immunotherapy. It is a bivalent vaccine derived from the pooled blood of hepatitis B and C carriers. V5 inherently contains circulating M. tuberculosis antigens. V5 involves heat- and chemical inactivation with subsequent formulation into a tablet. It was also under development for the treatment of tuberculosis, HIV/AIDS and hepatitis C.

Immunitor overview

Immunitor, a subsidiary of Immune Network Ltd is a developer of orally-delivered immune therapies. The company’s proprietary technology formulates vaccines as oral pills. Its products are used prevent and treat viral infections such as HIV, hepatitis B and C, influenza, tuberculosis, broad spectrum bacterial and fungal infections, cancer, and atherosclerosis and obesity. Immunitor’s technology enables to formulate vaccines as oral pills. In addition, the company offers therapeutic vaccines and oral products. It operates GMP manufacturing facilities in Thailand. Immunitor is headquartered in Vancouver, British Columbia, Canada.

Quick View Hepcortespenlisimut-L LOA Data

Report Segments
  • Innovator
Drug Name
  • Hepcortespenlisimut-L
Administration Pathway
  • Oral
Therapeutic Areas
  • Infectious Disease
  • Oncology
Key Developers
  • Sponsor Company: Immunitor
  • Originator: Immunitor
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.