InnaVirVax, biopharmaceutical company dedicated to the development of therapeutic and diagnostic solutions in pathologies associated with immune dysregulation, announces today promising preclinical results of its therapeutic vaccine VAC-3S, which aims at preserving the immune system of patients infected with HIV-1.

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 cells during infection, the vaccine candidate VAC-3S is designed to combat the pathogenicity of the virus by blocking the decrease of the of CD4 + T lymphocytes cell count.

This innovative vaccine approach stems from the original scientific work completed at the Pitié Salpêtrière Hospital by Prof. Patrice Debré and Dr. Vincent Vieillard (UMR INSERM and University Pierre et Marie Curie UMRS 946). This work has been released in seven international peer-reviewed journals. The VAC-3S project was supported by the French National Research Agency as part of a collaborative project with the UMRS 946 and the 'Comissariat à l'Energie Atomique'. This support has enabled the consolidation of the proof of concept of the vaccine approach developed by InnaVirVax, specifically the protection of CD4 + T lymphocytes cells during the disease. In addition, InnaVirVax has developed a manufacturing process of the vaccine candidate, compatible with subsequent industrial use.

Studies of toxicity and local tolerance of the vaccine candidate VAC-3S have just been completed. Conducted under Good Laboratory Practice (GLP) at the CIT (Evreux, France), the results showed the absence of toxicity of the vaccine.

Launch of Phase I / IIa clinical trials. Based on the obtained results, InnaVirVax will file to the AFSSAPS, the French drug agency, a request for a Phase I / IIa clinical trial authorization.

The main objective of this trial, which will be carried out in France will focus on the safety and immunogenicity of VAC-3S in patients infected with HIV-1. Some efficacy parameters such as CD4 count, viral load and cellular activation will be studied during as secondary objective.

Joël Crouzet, CEO of InnaVirVax declared: «The excellent results obtained by our vaccine candidate VAC-3S confirm the validity of our cutting edge technology protecting the immune system. Complementary to antiretrovirals that target the replication and the spread of the virus, the new class of drugs represented by VAC-3S is designed to block the pathological consequences of infection and thus the collapse of the immune system. The protection and preservation of CD4+ T lymphocyte cells represent a major challenge which could provide a tremendous response to HIV-infected patients treated or untreated with antiretroviral drugs at different stages of disease progression».

About preclinical studies of vaccine VAC-3S: Studies of toxicity and local tolerance of the vaccine candidate VAC-3S were performed in rats following the recommendations of regulatory agencies. Vaccine doses identical to the ones planned to be used in patients were injected intramuscularly to the animals.

Repeated VAC-3S vaccinations did not produce toxic effects and lesions both at the systemic level and at the injection site.