Vical Incorporated today announced that it has entered into a $4 million contract with the IPPOX Foundation to manufacture HIV-antigen plasmid DNA as a component of vaccine regimens to be evaluated in clinical trials for the prevention of HIV infection. IPPOX is a Swiss non-profit foundation that participates in the conduct of HIV vaccine clinical trials under the auspices of the Pox-Protein Public-Private Partnership (P5), funded by the Bill & Melinda Gates Foundation and the U.S. National Institute of Allergy and Infectious Diseases (NIAID). The new contract builds upon Vical’s 2010 agreement with IPPOX to manufacture plasmid DNA for HIV vaccine clinical trials and recent encouraging clinical data.
“Based on the recent HIV vaccine Phase 1 clinical data, in which plasmid DNA, protein, and poxvirus-based vaccines were co-administered, plasmid DNA priming led to higher CD4+ and CD8+ T-cell responses,” said Giuseppe Pantaleo, M.D., President of IPPOX and Professor of Medicine, Chief, Division of Immunology and Allergy, Head, Laboratory of AIDS Immunopathogenesis, Department of Medicine at the Centre Hospitalier Universitaire Vaudois, University of Lausanne, Switzerland.
“Furthermore, co-administration of plasmid DNA and protein-based HIV vaccines during priming led to early induction of binding and neutralizing antibody responses. We believe that the inclusion of plasmid DNA will be a valuable component of a prophylactic HIV vaccine.”
The plasmids manufactured by Vical are expected to be used as priming components of prime/boost vaccine regimens that will be evaluated in additional Phase 1 studies and potentially in a Phase 2b clinical trial to follow. Vical expects material delivery to begin in the fourth quarter of 2015.
Additionally, Vical has signed a Memorandum of Understanding with the Gates Foundation to cooperate on HIV vaccine projects established under the P5 partnership. P5 seeks to advance and potentially license HIV vaccine candidates that have the potential to achieve a broad public health impact. Core funding for P5 is provided by the foundation and the NIH, and current partners include the foundation, U.S. National Institute of Allergy and Infectious Diseases/Division of AIDS, the HIV Vaccine Trials Network, Novartis Vaccines and Diagnostics, Sanofi Pasteur, the South Africa Medical Research Council, the U.S. Military HIV Research Program (MHRP), GlaxoSmithKline, and Centre Hospitalier Universitaire Vaudois (CHUV).
“Today’s announcement provides important validation for the utility of our DNA technology and the strength of our manufacturing expertise,”
said Vijay B. Samant, Vical’s President and CEO. “The results thus far suggest that Vical’s plasmid DNA may play an important role in the new vaccine regimens under development to prevent HIV infection. We are proud to be working in collaboration with IPPOX, the Bill & Melinda Gates Foundation and P5 on these initiatives to address an acute unmet medical need throughout the world.”