Title: Vical Receives $6 Million Grant From NIH to Advance
RapidResponse(TM) DNA Vaccine Platform Date: 6/12/2007 6:30:00 AM
SAN DIEGO, June 12, 2007 /PRNewswire-FirstCall via COMTEX News Network/ -- Vical
Incorporated (Nasdaq: VICL) today announced that the company has been awarded a
three-year, $6.0 million grant from the National Institute of Allergy and Infectious
Diseases (NIAID), part of the National Institutes of Health (NIH), for further development
of a DNA vaccine manufacturing process with the potential to produce several million doses
of vaccines in a matter of days.
"The standard manufacturing methods that are being used to produce conventional
vaccines take several months to several years and require specialized, capital-intensive
facilities," said Vijay Samant, President and Chief Executive Officer of Vical.
"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 a
pandemic influenza or SARS."
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 killed or disabled 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 Severe Acute Respiratory Syndrome
(SARS), an accidental release of a dangerous pathogen such as Ebola virus or Mycobacterium
tuberculosis 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.
Under initial research testing supported by a grant from the U.S. Defense Advanced
Research Projects Agency (DARPA), the company demonstrated 100% protection of mice against
a lethal challenge with H3N2 influenza after a single 2 microgram dose of
Vaxfectin(TM)-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(TM) 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 small segment of DNA, called a linear expression cassette
(LEC), which includes only those DNA sequences essential for the specific vaccine. 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.
Contacts: Investors: Media:
Alan R. Engbring Susan Neath
Vical Incorporated Porter Novelli Life Sciences
(858) 646-1127 (619) 849-6007
Website: http://www.vical.com
SOURCE Vical Incorporated
Investors, Alan R. Engbring of Vical Incorporated, +1-858-646-1127; or Media, Susan
Neath of Porter Novelli Life Sciences, +1-619-849-6007, for Vical Incorporated
http://www.vical.com
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