InnaVirVax receives DSMB recommendation to pursue VAC-3S Phase 2 study in HIV

Dec 2 2014

InnaVirVax, a biopharmaceutical company specialized in research and development on therapeutic and diagnostic solutions for diseases linked to immune dysregulation, today announces the recommendation of its independent Data Safety and Monitoring Board (DSMB) to pursue the Phase 2 study (IPROTECT1) of VAC-3S according to the planned protocol.

Initiated at the beginning of 2014, this European multicentric clinical study, which needs to be conducted on 90 patients, is at present actively recruiting patients living with HIV.

The primary objective of the Phase 2 study is to monitor and assess the antibody response to the VAC-3S vaccine. VAC-3S has been constructed to induce a humoral immune response against a highly conserved region of the gp41 envelope protein of HIV-1 known as 3S. This is a randomized, double-blind, placebo-controlled study in HIV-1 infected adults with a viral load of 50 copies/mm³ or lower, who are being treated with ART and whose CD4+ T-cell count at screening is between 200 and 500 cells/mm³. Three VAC-3S doses will be compared in a total of 90 patients living in France, Germany and Spain.

The VAC-3S candidate vaccine developed by InnaVirVax should constitute a new therapeutic class designed to preserve and restore the immune system of patients. VAC-3S should also become part of the therapeutic armamentarium to achieve a functional cure. The clinical development of VAC-3S is receiving support from Bpifrance within the framework of the PROTHEVIH consortium, which is being led by InnaVirVax.

Joël Crouzet, CEO of InnaVirVax declared:

Today, on World AIDS Day, pursuit of the clinical development of VAC-3S, an innovative candidate vaccine, is continuing according to our time-lines. In just one year we have advanced our work towards our main objective, which is to find a sustainable treatment for patients living with HIV.