LAS VEGAS, Dec. 11 /PRNewswire-FirstCall/ -- Vical Incorporated today announced that the company’s Vaxfectin(R)-formulated H5N1 pandemic influenza DNA vaccines induced T-cell responses against a matching strain of influenza virus and demonstrated cross-clade antibody responses against a different strain in a Phase 1 clinical trial. The company previously reported that the vaccines had achieved potentially protective levels of antibody responses in up to 67% of evaluable subjects in the trial’s higher dose cohorts. Vical researchers presented the expanded data, as well as new nonclinical data from the company’s RapidResponse(TM) DNA vaccine manufacturing program, this week at the DNA Vaccines 2008 Conference (Las Vegas - December 9-11).
H5N1 Pandemic Influenza Vaccine Phase 1 Trial Update
New data presented at the conference indicates that the company’s monovalent Vaxfectin(R)-formulated H5N1 pandemic influenza DNA vaccine induced T-cell responses against the H5 antigen in 75% to 100% of evaluable subjects in the various cohorts. T-cell responses could be important in protecting against serious disease and in limiting the spread of disease during an outbreak.
The monovalent vaccine, which was based on the H5N1 influenza virus strain, A/Vietnam/1203/04, also induced antibody responses against the H5N1 influenza virus strain, A/Hong Kong/156/97 from a different clade, in 50% of responders. Cross-clade responses could be important in providing protection against emerging strains of influenza before a matching vaccine could be deployed.
Antibody and/or T-cell responses against the matching H5 antigen and the conserved NP and M2 antigens were detected in a majority of subjects receiving the trivalent vaccine. Responses against conserved antigens could provide protection against serious disease or death during an outbreak of a new strain of influenza for which a vaccine had not yet been developed.
Vical had previously reported that the monovalent vaccine achieved potentially protective levels of antibody responses (H5 hemagglutination inhibition, or HI, titers of at least 40 and at least a four-fold increase from baseline) in at least 50% and up to 67% of evaluable subjects in a 100-subject Phase 1 trial. In the two monovalent vaccine cohorts receiving the highest H5 DNA dose (1 mg), 80% to 100% of the responders had sustained responses through Day 182.
Vical’s monovalent vaccine contained a plasmid (a closed loop of DNA) encoding the hemagglutinin (HA) surface protein from the H5N1 influenza virus strain, A/Vietnam/1203/04. It was designed primarily to elicit antibody responses against the H5 protein but could elicit T-cell responses against H5 as well. Vical’s trivalent vaccine contains the H5 plasmid plus separate plasmids encoding consensus sequences of two highly conserved influenza virus proteins: nucleoprotein (NP) and ion channel protein (M2). The trivalent vaccine was designed to elicit a combination of T-cell and antibody responses against all three proteins. Both vaccines were formulated with the company’s Vaxfectin(R) adjuvant, which has demonstrated effectiveness with a variety of DNA vaccines in multiple animal models as well as dose-sparing and immune-enhancing ability in animals with a conventional seasonal influenza vaccine.
RapidResponse(TM) DNA Vaccine Manufacturing Update
New data presented at the current conference indicates that a single injection of a Vaxfectin(R)-formulated influenza vaccine produced by the company’s RapidResponse(TM) manufacturing system provided complete protection of mice against challenge with highly lethal doses of H3N2 influenza virus. A dose response was apparent, as mice vaccinated with decreasing doses below a threshold level were afforded decreasing protection. The ratio of Vaxfectin(R) adjuvant to DNA in the vaccine also affected the protective efficacy of the vaccine. In separate tests, the use of alternative PCR primers, an integral part of the RapidResponse(TM) manufacturing process, did not significantly affect the protective efficacy of the resulting product.
The RapidResponse(TM) system is designed to allow extremely rapid and large-scale production of DNA vaccines with low capital requirements. 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).
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 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 results of the company’s Vaxfectin(R)-formulated H5N1 influenza DNA vaccine Phase 1 clinical trial and the results of nonclinical mouse studies of Vaxfectin(R)-formulated influenza vaccines produced by the company’s RapidResponse(TM) manufacturing system. Risks and uncertainties include whether Vical or others will continue development of the H5N1 pandemic influenza vaccines or the RapidResponse(TM) DNA vaccine platform; whether H5N1 influenza DNA vaccine Phase 1 clinical trial results will be confirmed in larger studies; whether nonclinical results from mouse studies will advance to human clinical testing, and if so, whether such testing will yield similar results; whether the company will receive all of the NIH grant funding; whether DNA vaccines against H5N1 influenza or any other targets will be successfully developed and commercialized; 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 Vical or others will secure funding to advance the pandemic influenza DNA vaccine program; whether any product candidates will be shown to be safe and efficacious in clinical trials; the timing of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market 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 of Vical Incorporated, +1-858-646-1127
Web site: http://www.vical.com/
