In February 2023 LinKinVax announced positive interim results from the ANRS VRI06 Phase I trial, evaluating a preventative HIV vaccine. This was conducted by sponsor INSERM-ANRS and the Vaccine Research Insititute. LinKinVax reports that the candidate is “safe” and “induces an early, significant, and sustained immune response”.
The vaccine candidate is developed by the Vaccine Research Institute (VRI) with LinKinVax technology, the first vaccine based on this technology, targeting an immune response binding HIV envelope protein to monoclonal antibodies specifically targeting CD40 receptors on dendritic cells. The Env protein is injected and “delivered directly” to the dendritic cells. The vaccine is combined with the Hiltonol adjuvant, “designed to enhance its potential action”.
Professor Yves Lévy, Executive Director of the VRI and CMSO of LinKinVax, explained that the candidate has done well so far, with the “immune response profile” it generated being “associated with a reduced risk of HIV infection in the RV144 trial”.
“However, at this early stage of vaccine development, it is important to remember that volunteers should continue to protect themselves from any risk of HIV infection, as the efficacy of the vaccine will only be evaluated in the Phase II/III studies.”
The ANRS VRI06 clinical study was conducted in France and Switzerland and included 72 healthy volunteers. Safety and immunogenicity were assessed at Weeks 6, 26, and 48, with results suggesting that it is “safe and well tolerated”.
Dr André-Jacques Auberton-Hervé, Co-founder and CEO of LinKinVax is “pleased” with the “promising immunogenicity results, which demonstrate the robustness of our DC Targeting vaccine platform and confirm its safety”.
“This important milestone paves the way for the upcoming Phase II/III clinical studies that we will conduct once the final Phase I results have been obtained. These studies will aim to demonstrate the efficacy of the vaccine, the ‘Everest of vaccine strategies’, which has been the elusive goal of HIV research for the past 40 years.”
For more on HIV vaccine updates, join us at the World Vaccine Congress in Washington this April.