Vical Highlights DNA Vaccine Technology Advances at ASGT Annual Meeting
SAN DIEGO, June 5 /PRNewswire-FirstCall/ -- Vical Incorporated (Nasdaq: VICL - News) researchers presented data from several of the company's DNA vaccine development programs at the annual meeting of the American Society of Gene Therapy (May 31 - June 4).
"Several lines of preclinical research using Vical's DNA vaccine technology have converged recently," said David C. Kaslow, M.D., Vical's Chief Scientific Officer, "including significant enhancements in efficacy using adjuvants or delivery devices, and substantial insights regarding predictors of efficacy beyond conventional vaccine assays. These developments, along with encouraging new data from human trials, provide increasing momentum in the progress of DNA vaccine development."
Alain P. Rolland, Pharm.D., Ph.D., the company's Senior Vice President of Product Development, presented an "Overview of Gene Vaccines" as part of the Industrial Liaison Committee workshop on June 1 chaired by Dr. Rolland. Highlights from a series of recent studies discussed in the overview included:
* Demonstration in rabbits that electroporation enhances onset and
magnitude of antibody production against an encoded cytomegalovirus
(CMV) antigen in the company's CMV vaccine program;
* Demonstration in cynomolgus monkeys that electroporation after
vaccination enhances anthrax lethal toxin neutralizing antibody
production by several orders of magnitude in the company's anthrax
vaccine program;
* Demonstration in rabbits that plasmid DNA is cleared from injected
muscles after intramuscular injection followed by electroporation and
that risk of integration into the host genome is negligible at 60 days;
and
* A previously reported demonstration in ferrets that a three-component,
Vaxfectin(TM)-formulated influenza DNA vaccine candidate provided 100%
protection against lethal challenge with a highly virulent H5N1 avian
influenza virus.
Peggy A. Lalor, Ph.D., the company's Executive Director of Preclinical Safety and Efficacy, presented an "Evaluation of a pDNA-Based Anthrax Vaccine and Immune Correlates of Protection in Mice and Non-Human Primates." Highlights from recent studies with the company's anthrax vaccine candidate included:
* Demonstration in mice and cynomolgus monkeys that a DNA vaccine may
induce a memory immune response for which conventional assays may not
be accurate predictors of protection; and
* Demonstration in mice and cynomolgus monkeys that a DNA vaccine
provides protective immunity that may be triggered by subsequent
exposure to the pathogen, suggesting a potential "pseudo-challenge" to
quantify the memory immune response when compared against unvaccinated
controls.
Financial support for the CMV vaccine, anthrax vaccine, and influenza vaccine studies was provided under previously-announced grants from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH). The electroporation technology used in these studies was licensed from Inovio Biomedical Corporation (Amex: INO - News).
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 has developed 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 serve significant unmet medical needs. Additional information on Vical is available at www.vical.com.
Based on the award of a procurement contract to a third party for a second-generation anthrax vaccine, the grant of Emergency Use Authorization for the first-generation anthrax vaccine, and discussions with government agencies, it appears that funding needed to support further clinical development of the company's third-generation anthrax vaccine will not be available in the foreseeable future. Therefore, the company does not intend to pursue further development of its anthrax vaccine candidate at this time.
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 adjuvants or delivery devices will improve DNA vaccine efficacy significantly, if at all; whether a new correlate for efficacy based on potential "pseudo-challenge" will overcome the limitations of conventional vaccine assays; whether Vical or others will continue development of the CMV or influenza vaccines; whether the CMV or influenza vaccines or any other product candidates will be shown to be safe and effective; the timing, nature and cost of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market the CMV or influenza vaccines or any other product candidates; whether Vical or its collaborative partners will succeed in marketing the CMV or influenza vaccines or any other 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.
"Several lines of preclinical research using Vical's DNA vaccine technology have converged recently," said David C. Kaslow, M.D., Vical's Chief Scientific Officer, "including significant enhancements in efficacy using adjuvants or delivery devices, and substantial insights regarding predictors of efficacy beyond conventional vaccine assays. These developments, along with encouraging new data from human trials, provide increasing momentum in the progress of DNA vaccine development."
Alain P. Rolland, Pharm.D., Ph.D., the company's Senior Vice President of Product Development, presented an "Overview of Gene Vaccines" as part of the Industrial Liaison Committee workshop on June 1 chaired by Dr. Rolland. Highlights from a series of recent studies discussed in the overview included:
* Demonstration in rabbits that electroporation enhances onset and
magnitude of antibody production against an encoded cytomegalovirus
(CMV) antigen in the company's CMV vaccine program;
* Demonstration in cynomolgus monkeys that electroporation after
vaccination enhances anthrax lethal toxin neutralizing antibody
production by several orders of magnitude in the company's anthrax
vaccine program;
* Demonstration in rabbits that plasmid DNA is cleared from injected
muscles after intramuscular injection followed by electroporation and
that risk of integration into the host genome is negligible at 60 days;
and
* A previously reported demonstration in ferrets that a three-component,
Vaxfectin(TM)-formulated influenza DNA vaccine candidate provided 100%
protection against lethal challenge with a highly virulent H5N1 avian
influenza virus.
Peggy A. Lalor, Ph.D., the company's Executive Director of Preclinical Safety and Efficacy, presented an "Evaluation of a pDNA-Based Anthrax Vaccine and Immune Correlates of Protection in Mice and Non-Human Primates." Highlights from recent studies with the company's anthrax vaccine candidate included:
* Demonstration in mice and cynomolgus monkeys that a DNA vaccine may
induce a memory immune response for which conventional assays may not
be accurate predictors of protection; and
* Demonstration in mice and cynomolgus monkeys that a DNA vaccine
provides protective immunity that may be triggered by subsequent
exposure to the pathogen, suggesting a potential "pseudo-challenge" to
quantify the memory immune response when compared against unvaccinated
controls.
Financial support for the CMV vaccine, anthrax vaccine, and influenza vaccine studies was provided under previously-announced grants from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH). The electroporation technology used in these studies was licensed from Inovio Biomedical Corporation (Amex: INO - News).
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 has developed 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 serve significant unmet medical needs. Additional information on Vical is available at www.vical.com.
Based on the award of a procurement contract to a third party for a second-generation anthrax vaccine, the grant of Emergency Use Authorization for the first-generation anthrax vaccine, and discussions with government agencies, it appears that funding needed to support further clinical development of the company's third-generation anthrax vaccine will not be available in the foreseeable future. Therefore, the company does not intend to pursue further development of its anthrax vaccine candidate at this time.
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 adjuvants or delivery devices will improve DNA vaccine efficacy significantly, if at all; whether a new correlate for efficacy based on potential "pseudo-challenge" will overcome the limitations of conventional vaccine assays; whether Vical or others will continue development of the CMV or influenza vaccines; whether the CMV or influenza vaccines or any other product candidates will be shown to be safe and effective; the timing, nature and cost of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market the CMV or influenza vaccines or any other product candidates; whether Vical or its collaborative partners will succeed in marketing the CMV or influenza vaccines or any other 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.
