Mymetics Corporation has announced that a paper describing detailed results of a successful preclinical trial on its innovative HIV-1 (Human Immunodeficiency Virus type 1) vaccine was recently published in the scientific journal Immunity.
Jacques-François Martin, CEO of Mymetics, commented, "The publication of these results is a highly significant milestone, not just for Mymetics but for the entire HIV vaccine field. Our strategy of inducing mucosal immunity is a major breakthrough in 15 years of thinking on the design of HIV vaccines. These data provide strong confirmation of the validity of our approach, which has now gained the keen interest of key opinion leaders, both in the HIV field and for the development of other vaccines."
The small-scale study on Chinese macaques, conducted by Mymetics at the Institute of Laboratory Animal Science (ILAS) in Beijing, China, demonstrated 100% protection in one arm of the study against multiple intra-vaginal challenges with heterologous live virus. None of the 5 vaccinated animals seroconverted to the p27gag antigen while all 6 placebo-vaccinated animals became rapidly infected and seroconverted. HIV-specific vaginal IgA and IgG antibodies were detected in most vaccinated animals.
An in vitro assay showed a correlation between protection and the induction of mucosal antibodies capable of blocking the passage of HIV-1 across a cell monolayer. Protected animals also had blood IgG antibodies but these totally lacked virus-neutralizing activity. These results are unprecedented for this type of HIV-1 vaccine study and confirm the importance of non-neutralizing antibodies for preventing HIV-1 transmission and early infection events, opening the door to new vaccine designs.
The study was performed in close collaboration with Dr. Morgane Bomsel from the Cochin Institute and INSERM, Paris, who originally described the gp41-derived peptide P1, which is part of the Mymetics vaccine, and demonstrated the importance of this area of gp41 for mucosal protection. Key analyses were conducted in her laboratory.
Mymetics co-developed the HIV-1 vaccine with its industrial partner Pevion Biotech, using proprietary virosome technology, as well as with Px-Therapeutics for its expertise in judicious antigen design and the improvement of antigens to face upscale and GMP production. With its vaccine, Mymetics aims to provide both a first line of defense through mucosal protection and a second line of defense against infection through the generation of blood antibodies.
In January 2011, the Mymetics vaccine successfully completed a Phase I trial in healthy female volunteers, for which final results will be reported in the coming weeks. In parallel, Mymetics will continue its efforts to develop a vaccine formulation suitable for warm countries and offering cross-clade protection, and is planning for the next clinical trials.