InnaVirVax, a biopharmaceutical company dedicated to the development of therapeutic and diagnostic solutions in pathologies associated with immune dysregulation, declared today that it has obtained authorization from the French drug agency (AFSSAPS) to start a Phase I/IIa clinical study of its therapeutic vaccine VAC-3S for the treatment of HIV infections. This authorization intervenes only two years and half after the launching of InnaVirVax’s activities.
VAC-3S – a cutting edge vaccine approach for the treatment of HIV infections. Based on the understanding of the mechanism responsible for the decline of the CD4+ T lymphocytes during infection, the VAC-3S vaccine candidate is designed to fight the pathogenicity of the virus by blocking the decrease of the of CD4+ T lymphocytes count and to protect the immune system by reducing immune activation and inflammation.
This innovative vaccine approach stems from the scientific work led at the Pitié Salpêtrière Hospital by Prof. Patrice Debré and Dr. Vincent Vieillard (joint INSERM and University Pierre et Marie Curie unit UMRS 946). This work has been released in seven articles published in international peer-reviewed journals.
This Phase I/IIa clinical study will be carried out in two clinical centers from the Assistance Publique – Hôpitaux de Paris: the Pitié Salpêtrière and the Cochin Hospitals. This dose escalation study will enroll 24 HIV-infected patients under antiretroviral therapy.
The main objective of this trial is to focus on the safety of the VAC-3S vaccine. The immunogenicity of the vaccine will also be studied as well as the positive effects on the markers of disease (CD4 count, viral load and cellular activation for instance). The patients will be vaccinated and then monitored during one year. The primary endpoints of the clinical trial will be studied three months after the first vaccination of each patient.
Patrice Debré, Professor of Immunology at the University Pierre et Marie Curie (Paris) and physician at the Pitié Salpêtrière Hospital and co-inventor of the discovery developed by InnaVirVax, declared: “This authorization delivered by the French competent authorities, represents a major step allowing us to assess in human a new vaccine with an important therapeutic potential for the treatment of HIV infections. This vaccine is based on a new concept, aiming at protecting the immune system from the deleterious effects that the HIV induces during the infection.”
Professor Christine Katlama, form the Department of Infectious and Tropical Diseases at the Pitié-Salpêtrière Hospital and principal investigator of the Phase I/IIa clinical trial, added: “Knowing the stakes represented by the treatment of a large majority of HIV-infected patients with about 6 million on antiretroviral therapy over the 33 million who are infected, knowing the costly therapy, which needs to be performed on a life long basis, knowing the impossibility to eradicate the infection, we definitely need to have innovative concepts and therapeutic approaches. The innovation represented by the vaccination against viral missiles that deregulate patients’immunity is among such type of caliber. If the vaccine that we are going to assess brings, as it did in animal studies, a benefit by protecting the CD4+ T lymphocytes from depletion and by decreasing the immune activation, a major step would have been overcome.”
Joël Crouzet, CEO of InnaVirVax concluded: “The excellent results obtained by our VAC-3S vaccine candidate confirm the validity of our cutting edge technology protecting the immune system. VAC-3S represents a first-in-class therapy for the treatment of HIV infections. It should act complementary to antiretrovirals. The clinical development that we are initiating will allow us to know if the observational data coming from patients and showing the potential of this innovating therapy are confirmed when our vaccine is administrated to patients. The protection of the immune system during this disease is a major goal which could bring in a tremendous answer for the patients infected by HIV.”
Researchers receive NIH grant to help develop gene therapy for HIV