TherVacB is a cutting-edge therapeutic vaccination technology, made in Europe.
Led by Prof. Protzer Ulrike and her team in Munich, pioneering research has unveiled a critical barrier to effective therapy: the presence of high levels of hepatitis B virus proteins in the liver dampening the body’s immune response. The innovative therapeutic vaccine, TherVacB, has been developed specifically to induce a broad immune response against these viral proteins and to facilitate a cure and it is now entering the clinical phase. As part of this collaboration, MONIPOL will join the EU consortium for managing the Phase 1b/2a study within the EU-funded TherVacB project. In this multicenter, multinational study involving chronic hepatitis B patients, the safety, tolerability, and immunogenicity of this innovative vaccine candidate will be evaluated.
Saskia Borregaard , Executive Director of Clinical Development at MONIPOL, highlighted the pivotal role of academic studies in clinical research, stating: “Academic studies are crucial for improving patient outcomes, pushing the boundaries of scientific knowledge, and nurturing the development of novel therapies.” TherVacB stands as a testament to the collaborative efforts between academia and industry, offering a significant advancement in the treatment paradigm.
Participating in the TherVacB Consortium, MONIPOL demonstrates a commitment to advancing clinical research and contributing to the development of new therapies that have the potential to improve patient outcomes globally. TherVacB potentially provides a novel and affordable, curative treatment option for chronic hepatitis B for a large number of patients worldwide.
Tin Nguyen, Managing Director of MONIPOL, expressed excitement about the partnership, stating, “We look forward to supporting leading virologists, immunologists, and physicians in this project, and leveraging our extensive experience with Investigator-Initiated Trials (IIT) to contribute to its success.”
MONIPOL is currently preparing to contribute to the first-in-patient phase 1b/2a trial, with LMU Munich University Hospital as the Sponsor of the clinical trial represented by Prof. Michael Hoelscher. This trial will follow the phase 1a open-label study on safety and immunogenicity, which Prof. Marylyn Martina Addo leads as the coordinating investigator and the University Medical Center Hamburg-Eppendorf (UKE) as the Sponsor of the clinical trial.
Further information
About the scientists
Prof. Dr. Ulrike Protzer, Deputy Head of the Molecular Targets and Therapies Center at Helmholtz Munich, Director of the Institute of Virology at Helmholtz Munich and the Technical University of Munich, Professor of Virology at TUM School of Medicine and Health.
Prof. Dr. Marylyn Addo, Director of the Institute for Infection Research and Vaccine Development, University Medical Center Hamburg-Eppendorf and Bernhard-Nocht-Institute for Tropical Medicine.
Dr. Mirjam Schunk, Head of the Clinical Study Center at the Division of Infectious Diseases and Tropical Medicine, LMU University Hospital Munich.
About MONIPOL
Founded in 1995, MONIPOL | Clinical Research is an owner-led CRO with German and Polish roots and strong regional partnerships across Europe. Leveraging over 25 years of experience in monitoring and organizing multicenter clinical trials, MONIPOL is committed to tailored solutions for the various needs of biotechnology and small/midsize pharma companies, to support them in bringing new and innovative therapies to market. MONIPOL’s offering includes the conduct of Phase I-IV clinical trials in a wide range of therapeutic areas, with a particular focus on infectious diseases.
EU Funding Acknowledgment & Disclaimer
The first-in-patient phase 1b/2a study is funded by the European Union’s H2020 under Grant Agreement 848223 (TherVacB). Views and opinions expressed herein reflect only the author’s views, they do not necessarily reflect those of the European Union or the European Commission. Neither the European Union nor the granting authority can be held responsible for any use that may be made of the information contained herein.
