Vical to Manufacture HIV Vaccines for Clinical Evaluation by Public-Private Partnership Initiative
April 22 2015 - 6:30AM
- Vical to receive $4 million under new contract with IPPOX
Foundation, funded via a grant from the Bill & Melinda Gates
Foundation, to supply plasmid DNA for HIV vaccine clinical
trials
- Builds on recent encouraging results from HIV vaccine clinical
studies involving plasmid DNA manufactured by Vical
- Vical signs Memorandum of Understanding with the Gates
Foundation to cooperate on HIV vaccine projects
Vical Incorporated (Nasdaq:VICL) 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."
About Vical
Vical develops biopharmaceutical products for the prevention and
treatment of chronic or life-threatening infectious diseases, based
on its patented DNA delivery technologies and other therapeutic
approaches. Additional information on Vical is available at
www.vical.com.
Forward-Looking Statements
This press release contains forward-looking statements subject
to risks and uncertainties that could cause actual results to
differ materially from those projected. Forward-looking statements
include Vical's capabilities to deliver all, if any, of the
plasmids by the specified date, and the potential role of plasmid
DNA in HIV vaccines. Risks and uncertainties include whether all
funding under the contract will be received by the company; whether
Vical will be able to perform its obligations under the contract;
whether the P5 will continue development of the HIV vaccine
candidate; whether planned clinical development of the HIV vaccine
candidate will begin when expected, or at all; risks associated
with clinical development of vaccine candidates; and additional
risks set forth in the company's filings with the Securities and
Exchange Commission. These forward-looking statements represent the
company's judgment as of the date of this release. The company
disclaims, however, any intent or obligation to update these
forward-looking statements.
CONTACT: Andrew Hopkins
(858) 646-1127
Website: www.vical.com
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