HB-101 is under clinical development by Hookipa Pharma 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 HB-101’s likelihood of approval (LoA) and phase transition for Cytomegalovirus (HHV-5) Infections took place on 15 Aug 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 HB-101 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

HB-101 overview

HB-101 (Vaxwave) is under development for the prevention of cytomegalovirus infections in solid organ transplant patients. It is administered intramuscularly. It is a bivalent vaccine containing two recombinant, replication-deficient lymphocytic choriomeningitis virus (rLCMV) vectors, one expressing the pp65 protein and one expressing the gB protein of human cytomegalovirus (HCMV). It is based on Vaxwave technology.

Hookipa Pharma overview

Hookipa Pharma (Hookipa) is a clinical-stage biopharmaceutical company that develops novel class of immunotherapeutics against infectious diseases and cancers. Its pipeline products include HB-101, a prophylactic cytomegalovirus vaccine candidate; HB-202 and HB-201, immuno-oncology product candidates for the treatment of human papillomavirus-positive cancers; and HB-301, targeting prostate cancer. Hookipa’s proprietary arenavirus-based technologies, VaxWave, a replication-deficient viral vector, and TheraT, a replication-attenuated viral vector, are designed to induce antigen specific cytotoxic T cells and pathogen-neutralizing antibodies for prophylactic and therapeutic purposes activating body’s immune response. The company collaborates with Gilead Sciences Inc for the development of immunotherapies to treat HIV and Hepatitis B. It operates a research and preclinical development center in Vienna, Austria. Hookipa is headquartered in New York City, New York, the US.

Quick View HB-101 LOA Data

Report Segments
  • Innovator
Drug Name
  • HB-101
Administration Pathway
  • Intramuscular
Therapeutic Areas
  • Infectious Disease
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.