SAN DIEGO, June 25 CA-Vical-DNA-Vaccine
SAN DIEGO, June 25 /PRNewswire-FirstCall/ -- Vical Incorporated
(Nasdaq: VICL) today announced that the company has successfully completed
first-year milestones under a three-year, $6.0 million grant awarded in 2007,
and is advancing with the development of a DNA vaccine manufacturing process
with the potential to produce several million doses of vaccines in a matter of
days.
The RapidResponse(TM) system is designed to allow extremely rapid and
large-scale production of DNA vaccines with low capital requirements. It is
ideally suited to enable an immediate response against emerging diseases
affecting large populations, such as pandemic influenza or severe acute
respiratory syndrome (SARS). The company is proceeding with the development of
the RapidResponse(TM) platform under the second year of grant funding awarded
by the National Institute of Allergy and Infectious Diseases (NIAID), part of
the National Institutes of Health (NIH). Separately, Vical has completed
enrollment in its Phase 1 testing of the company's Vaxfectin(R)-formulated
pandemic influenza DNA vaccines, and expects to release results by August
2008.
About the RapidResponse(TM) Platform
The RapidResponse(TM) DNA vaccine manufacturing platform is intended to
significantly reduce the time required to develop, manufacture and deploy
vaccines against emerging diseases during the early stages of an infectious
outbreak. By using a cell-free manufacturing process, the company believes
that the RapidResponse(TM) DNA platform can overcome the time, capacity and
cost challenges of manufacturing conventional vaccines for diseases such as
influenza, which use viruses grown in chicken eggs or via cell culture,
requiring months of production time in large, dedicated facilities.
RapidResponse(TM) DNA vaccine manufacturing involves a cell-free process
and single-step vaccine purification. The process has the potential to be
scaled up by simply using larger equipment with no increase in production
time, conceivably allowing production of hundreds of millions of doses of DNA
vaccine during the earliest stages of an outbreak. Such speed and scale may be
crucial in addressing a naturally emerging potentially pandemic disease such
as influenza or SARS, an accidental release of a dangerous pathogen such as
Ebola virus or Yersinia pestis (plague bacterium) from a biological
containment facility, or an intentional release of a weaponized or
bioterrorist-modified pathogen designed to cause diseases such as anthrax or
smallpox.
Initial research testing demonstrated 100% protection of mice against a
lethal challenge with an H3N2 influenza virus after a single 2 microgram dose
of Vaxfectin(R)-formulated DNA vaccine produced by polymerase chain reaction
(PCR). Next steps in the development of the RapidResponse(TM) DNA vaccine
platform will include determination of the lowest effective dose, head-to-head
comparison against plasmid DNA vaccine, Vaxfectin(R) formulation optimization,
and scale-up in adherence with current Good Manufacturing Practices (cGMP) to
production of quantities appropriate for initial human clinical trials.
The PCR process produces a segment of DNA, called a linear expression
cassette (LEC), which includes only those DNA sequences essential for
eliciting immune responses. The bacterial fermentation process typically used
for DNA vaccines produces a closed loop of DNA, called a plasmid, which
includes DNA sequences required by the bacteria in the manufacturing process.
Vical holds patents in the United States and in other key regions based on the
company's discovery that administering polynucleotides such as DNA or RNA to
tissues, without the use of viral delivery vehicles, may cause expression of
the proteins encoded by the polynucleotides. Vical's patent coverage includes
delivery of linear DNA as well as plasmid DNA.
Currently plasmid DNA vaccines, which are under development against
pandemic influenza and other infectious diseases at Vical, are manufactured by
bacterial fermentation in standardized equipment with a production time
measured in weeks rather than months. While plasmid DNA vaccines offer a
significant improvement over conventional vaccine manufacturing technologies,
the RapidResponse(TM) DNA vaccine platform could offer further advantages,
especially in greater speed of production and lower cost. The company plans to
continue development of its plasmid DNA vaccine programs because the
technology is much closer to commercial realization in humans.
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, including: whether Vical or others will continue development
of the RapidResponse(TM) DNA vaccine platform; whether the company will
receive all, if any, of the NIH grant funding; whether the RapidResponse(TM)
platform will reduce the time required to develop, manufacture and deploy
vaccines against emerging diseases during the early stages of an infectious
outbreak and overcome the time, capacity and cost challenges of manufacturing
conventional vaccines; whether RapidResponse(TM) platform will successfully be
scaled up to allow the production of hundreds of millions of doses of DNA
vaccines during the earliest stages of an outbreak; whether the
RapidResponse(TM) platform will be applicable to a broad range of emerging
diseases; whether the company's DNA vaccine candidates will be effective
against emerging pathogens; whether the influenza vaccine or any other product
candidates will be shown to be safe and effective in clinical trials; the
timing, nature and cost of clinical trials; whether Vical or its collaborative
partners will seek or gain approval to market the influenza vaccine or any
other product candidates; whether Vical or its collaborative partners will
succeed in marketing any product candidates; whether the company's issued
patents will be challenged and whether such challenges will have an adverse
effect on the scope of the patents; whether the company will enforce its
issued patents or will be successful in any enforcement efforts; whether the
company will be issued additional patents on the RapidResponse(TM) process or
applications; 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
