LinKinVax, a clinical-stage biotechnology company, is thrilled to announce the promising interim results of the ANRS VRI06 Phase I trial evaluating a preventive HIV vaccine. The trial was sponsored by the INSERM-ANRS and the Vaccine Research Institute (ANRS and Université Paris-Est Créteil, France). The results show that the vaccine candidate is safe and induces an impressive, long-lasting immune response. This is an encouraging development in the fight against HIV.
The CD40.HIVRI.Env vaccine candidate is a revolutionary development by the VRI and LinKinVax, utilizing an exclusive worldwide technology. This is the first vaccine to target an immune response to HIV by binding its envelope protein to CD40 receptors on dendritic cells. By injecting this protein, it is delivered directly to these cells, allowing them to educate and activate the immune system in an unprecedented way.
Andre-Jacques Auberton-Hervé, Co-founder and CEO of LinKinVax, enthusiastically declared: “We are thrilled with the encouraging immunogenicity results, which demonstrate the robustness of our DC Targeting vaccine platform and its safety. This landmark accomplishment paves the way for our upcoming Phase II/III clinical studies that will aim to demonstrate the efficacy of the vaccine – the “Everest of vaccine strategies” that has been the long-sought-after target of HIV research for the past four decades.”
The CD40.HIVRI.Env vaccine candidate has proven its safety and capacity to elicit a rapid, potent, and prolonged response. Clinical trials have revealed the vaccine’s ability to produce a specific immune response profile, one that has been linked to a diminished risk of HIV infection, as demonstrated in the RV144 trial. Nevertheless, it is imperative to remember that the vaccine’s efficacy will only be established during Phase II/III studies. As such, it is critical that volunteers continue to protect themselves from any potential HIV risk.
ANRS VRI06 clinical study
This Phase I study, which was conducted in France and Switzerland, saw the enrollment of 72 healthy volunteers by the end of October 2022. An interim analysis of the results was performed on the first 36 participants.
This innovative dose escalation study explored the safety and efficacy of a vaccine combined with the Hiltonol® adjuvant. Twelve participants received a 0.3 mg subcutaneous injection at the start of the study and at Weeks 4 and 24. The second and third groups then received doses of 1 and 3 mg, respectively, to determine the optimal dose of the vaccine.
In this double-blind trial, volunteers were injected with either a placebo or an active agent. To assess the safety and immunogenicity, the participants were monitored at Weeks 6, 26 and 48.
Safety and tolerance
At Week 26, the results from the first 36 volunteers (average age 34 years, 64% male) showed that the vaccine candidate was safe and well tolerated. This group of diverse individuals provided an invaluable contribution to the development of a vaccine that could potentially save countless lives.
Promising induction of an effective immune response to HIV
The vaccine proved to be extremely efficacious, with high levels of antibodies directed against HIV envelope being detected in all groups (0.3, 1 and 3 mg). At Week 6, 80-100% of all groups showed the presence of antibodies, and by Week 26 this had reached 100% in all groups. Additionally, antibodies targeting the V1/V2 region of the HIV envelope protein were observed, and at Week 26, 50% of the 0.3 mg group and 100% of the other two groups showed neutralising antibodies. Most impressively, the counts of CD4+ T cells targeting the HIV envelope protein remained stable until Week 48, indicating the vaccine’s long-term effectiveness.
About LinKinVax technology :
LinKinVax’s innovative vaccine platform utilizes a humanized monoclonal antibody to target the CD40 molecule expressed by dendritic cells, DC, which is essential for stimulating the immune system. By merging the antibody with regions of pathogens of interest, this platform can activate the immune system with a minimal amount of antigen, even without the use of an adjuvant. Not only does this strategy produce lasting cellular and humoral immunity, but it also benefits from the extensive safety record of protein-based vaccines, which have been used for over 30 years.
In a major breakthrough, three promising products are in the midst of being tested in clinical trials: a prophylactic vaccine for HIV being led by Inserm/ANRS in phase I, a SARS-CoV-2 vaccine designed to cover variants of interest, and a therapeutic vaccine for human papillomavirus-related cancers. These groundbreaking advancements in medical science offer hope in the fight against some of the world’s most dangerous diseases.
LinKinVax, founded in 2020 and led by two renowned industry and medical figures, André-Jacques Auberton-Hervé, Honorary Chairman and founder of SOITEC, and Prof. Yves Levy, MD, PhD, immunologist, and Director of the Vaccine Research Institute (VRI/ANRS/UPEC), is revolutionizing the vaccine industry. Its innovative DC Targeting-based protein vaccine platform has the potential to quickly adapt to changes and mutations in the target pathogens, providing a faster and more efficient way to produce vaccines. With this breakthrough technology, LinKinVax is on the cutting edge of vaccine development.