SAN DIEGO, Aug. 19 — Vical Incorporated
(Nasdaq: VICL) today announced a research collaboration with the Karolinska
Institutet (KI), a leading European medical university, and the Swedish
Institute for Infectious Disease Control (SMI), a governmental expert
agency, to evaluate Vical’s Vaxfectin(R) adjuvant with the Biojector(R)
2000 needle-free injection system (Bioject Medical Technologies Inc.,
OTCBB: BJCT) for a multivalent preventive DNA vaccine against HIV.
Professor Eric Sandstrom, M.D., Ph.D., Professor at the Karolinska
Institutet, said, “The results from our initial Phase 1 trial were quite
good, with over 90 percent of subjects achieving detectable immune
responses against HIV after the prime-boost vaccination. We hope to improve
the breadth and magnitude of immune responses in the next clinical trial by
using the Vaxfectin(R) adjuvant with our DNA priming vaccine. We believe
that continued development of HIV vaccines remains among the world’s top
healthcare priorities.”
The Karolinska Institutet has completed a 38-subject Phase 1 trial
testing a prime-boost HIV vaccine regimen using three doses of unadjuvanted
DNA vaccines over a three-month period followed by a single dose of a viral
vector vaccine at nine months. The Karolinska Institutet is currently
conducting nonclinical safety studies to support a planned Phase 1 trial of
a Vaxfectin(R)-formulated HIV DNA vaccine as part of a prime-boost regimen.
The Vaxfectin(R) adjuvant is intended to optimize the priming of immune
responses and increase the performance of, or potentially even eliminate
the need for, the viral vector vaccine boost. The SMI is sponsoring the
development.
About the Vaccine
The SMI/KI vaccines contain synthetic versions of genes encoding
internal and surface proteins from different HIV subtypes. The combination
is designed to provide protection against the most prevalent HIV strains
circulating in Europe, Africa and The Americas. The prime-boost approach
uses two vaccine components given at different times. The two vaccine
components differ in how the genes are packaged. The DNA prime vaccine
component contains only the specific gene sequences in a plasmid DNA ring,
and cannot reconstitute into an infectious virus. The HIV DNA vaccine was
developed by the SMI and the Karolinska Institutet in Sweden. The viral
vector boost vaccine component uses a Modified Vaccinia Ankara (MVA) virus
(the virus that causes cowpox) to shuttle the same non-infectious gene
sequences into the body. The boost vaccine component was developed by the
NIH and Walter Reed Army Institute of Research, and does not use an
adjuvant.
In the first Phase 1 trial, the DNA priming vaccines were delivered
with the Biojector(R) 2000 needle-free injection system into either the
muscle or the skin. In the next trial, the Vaxfectin(R)-formulated DNA
vaccines would be delivered with the Biojector(R) 2000 needle-free
injection system into the skin. The MVA boost vaccine is delivered by
needle and syringe.
Recently reported preliminary results from Vical’s Phase 1 trial of the
company’s H5N1 pandemic influenza DNA vaccines marked the first time the
Vaxfectin(R) adjuvant was tested in humans. Some cohorts were vaccinated by
needle and syringe into the muscle and some with the Biojector(R) 2000
needle-free injection system into the muscle. The proposed KI/SMI study
would mark the first human test of a Vaxfectin(R)-formulated vaccine
delivered by needle-free injection into the skin. Intradermal delivery by
needle-free injection and use of the Vaxfectin(R) adjuvant may increase the
immune responses to the vaccine.
About Vaxfectin(R)
Vaxfectin(R) was designed by Vical to increase the immune response to
DNA vaccines. Vaxfectin(R)-formulated DNA vaccines have demonstrated good
tolerability and significant immune responses in multiple animal models,
including nonhuman primates, and recently underwent successful initial
human testing with the company’s H5N1 pandemic influenza DNA vaccines.
Vaxfectin(R) has also demonstrated a dose-sparing effect with the
commercial seasonal influenza and government-stockpiled H5N1 pandemic
influenza vaccines. Vaxfectin(R) may have potential applications as an
adjuvant for other protein-based vaccines as well. The company holds
patents covering Vaxfectin(R) and its use with DNA vaccines and
conventional vaccines against infectious diseases and cancer.
About Vical
Vical researches and develops biopharmaceutical products based on its
patented DNA delivery technologies for the prevention and treatment of
serious or life-threatening diseases. Potential applications of the
company’s DNA delivery technology include DNA vaccines for infectious
diseases or cancer, in which the expressed protein is an immunogen; cancer
immunotherapeutics, in which the expressed protein is an immune system
stimulant; and cardiovascular therapies, in which the expressed protein is
an angiogenic growth factor. The company is developing certain infectious
disease vaccines and cancer therapeutics internally. In addition, the
company collaborates with major pharmaceutical companies and biotechnology
companies that give it access to complementary technologies or greater
resources. These strategic partnerships provide the company with mutually
beneficial opportunities to expand its product pipeline and address
significant unmet medical needs. Additional information on Vical is
available at http://www.vical.com.
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 statements about the
Karolinska Institutet’s and the SMI’s plans for a prime-boost HIV vaccine
clinical trial, the potential effect of the company’s Vaxfectin(R) adjuvant
and Biojector(R) 2000 needle-free injection system on vaccine performance,
and the design and potential benefits of HIV DNA vaccines generally. Risks
and uncertainties include whether Vical, the Karolinska Institutet the SMI
or others will continue development of the HIV vaccine; whether the SMI
will sponsor and the Karolinska Institutet will complete preclinical
testing and conduct a Phase 1 trial using a Vaxfectin(R)-formulated DNA
prime-MVA boost vaccination regimen; whether such trial, if conducted, will
use the Biojector(R) 2000 needle-free injection system to deliver the DNA
priming vaccine; whether Vaxfectin(R) will optimize the DNA vaccine priming
of immune responses against the specific HIV vaccine targets and increase
the performance of, or eliminate the need for, the MVA vaccine boost;
whether Vaxfectin(R)-formulated DNA priming vaccines will increase the
breadth and magnitude of immune responses to the prime-boost regimen;
whether the prime-boost vaccine regimen will be effective in protecting
humans against HIV infection or disease; whether the HIV vaccine will
achieve the safety and immunogenicity endpoints in the Phase 1 trial;
whether Vical or its collaborative partners will seek or gain approval to
market any product candidates; whether Vical or its collaborative partners
will succeed in marketing any product 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: Alan R. Engbring
(858) 646-1127
Website: http://www.vical.com
SOURCE Vical Incorporated