Vaccines Conference in Boston, September 23 - 25, 2009

The Vaccines Development Conference brings together scientists and industry experts in all aspects of vaccine development to share what’s working and not working for them, and to address your key vaccine development challenges and questions. The conference is held Boston, September 23 - 25, 2009.

Conference highlights:

• Novel Adjuvant Development: Hear current advances in novel adjuvants with discussions and case studies from National Cancer Institute, NIH, Big DNA, Datamonitor and Vical
• Thermostability: Learn formulation strategies from Program for Appropriate Technology in Health
• Delivery: Uncover the latest vaccine delivery advances and the stabilization, potency testing, and formulation developments associated with needle-free delivery with case studies from Georgia Tech, Aktiv-Dry/University of Colorado, and Program for Appropriate Technology in Health (PATH)
• Analytical Testing: Master the most appropriate and efficient analytical testing methods and techniques to evaluate and analyze your vaccines with case studies from Wyeth Vaccines and Genzyme
• Potency and Immunogenicity Testing: Strategize with Acambis/Sanofi-Pasteur, VirXsys, and BigDNA to uncover strategies for improved vaccine assessment
• Manufacturing & Process Development: Tap into efficient and comparable manufacturing, scale up, and tech transfer approaches from Immunovaccine Technologies, BigDNA, and NIH.

Cancer Vaccine: Vical Presents Positive Preclinical Results

Vical Incorporated presents encouraging results from animal studies of a peptide-based cancer vaccine formulated with the company’s Vaxfectin(R) adjuvant. Sean M. Sullivan, Ph.D., Vical’s Executive Director of Pharmaceutical Sciences, is presenting data at the IIRUSA Vaccines Development Forum (Boston - September 23-25) demonstrating the adjuvant’s ability to enhance immune responses of cancer antigen-based vaccines in addition to a broad variety of DNA- and protein-based vaccines against infectious diseases.

“The Vaxfectin(R) adjuvant continues to demonstrate tremendous versatility in both infectious disease and cancer applications,” said Alain P. Rolland, Pharm.D., Ph.D., Vical’s Executive Vice President of Product Development. “The latest data showed that mice vaccinated with a Vaxfectin(R)-formulated TRP-2 melanoma tumor antigen peptide achieved significant improvements in cellular immune responses, reduced numbers of tumors, and a survival advantage compared with mice receiving control or no treatment. These data encourage further development of additional cancer applications and exploration of partnering opportunities.”

Results from a mouse study demonstrated an 88-fold increase in antigen-specific CD8+ T-cell responses at low doses and a 45-fold increase at high doses with a Vaxfectin(R)-formulated peptide-based cancer vaccine compared with unformulated vaccine. The Vaxfectin(R)-formulated cancer peptide also resulted in 7- to 14-fold higher responses than obtained with TRP-2 formulated with Freund’s adjuvant. In addition, the Vaxfectin(R)-formulated vaccine demonstrated a clear dose response when used at a constant adjuvant-to-peptide ratio. When evaluated against induced melanoma tumors, mice treated with the vaccine had statistically significantly fewer tumor lesions in the lungs compared with mice receiving no treatment or receiving a Vaxfectin(R)-formulated peptide control treatment. The mice receiving Vaxfectin(R)-formulated vaccine also demonstrated a significant survival advantage compared with untreated mice.

Vaxfectin(R)-formulated vaccines have demonstrated good tolerability and significant immune responses in multiple animal models, including nonhuman primates, and underwent successful initial human testing with the company’s H5N1 pandemic influenza DNA vaccines. Vaxfectin(R) has also demonstrated a dose-sparing effect (the ability to achieve the same vaccine effectiveness with lower vaccine doses) with commercial seasonal influenza and government-stockpiled protein-based H5N1 pandemic influenza vaccines.

HIV Vaccine: GenVec Receives Federal Funding

GenVec will receive up to $2.3 million for the 4th year to support the generation of HIV vaccine candidates with GenVec’s alternate adenovirus serotype technology. The National Institute of Allergy and Infectious Disease (NIAID) has executed its third option period (year four) under a previously announced, five-year contract with GenVec valued at up to $52 million for the production of HIV vaccines.

World Vaccine Congress Lyon 2009

World Vaccine Congress Lyon 2009, a Europe’s leading vaccine conference, will be held on October 5-8, 2009 in Lyon, France. The World Vaccine Congress Lyon is the annual vaccine conference addressing every aspect of vaccine research, vaccine development and vaccine manufacturing.

• Representation from key European Commission and regulatory agencies
• DG Research, DG SANCO, ECDC, EDQM, CHMP, VWP, MHRA, PEI, FAMHP and MEB provide vision and clarity on future industry progress and opportunities
• Europe’s largest commercial vaccine industry congress for decision makers across European and North America regions
• Including World class multiple speaker representation from Baxter, GSK Biologicals, MedImmune, Novartis Vaccines and Diagnostics, Pfizer, sanofi pasteur, sanofi Pasteur MSD, Solvay and Wyeth Vaccines
• Critical market opportunities outlined in billion Euro vaccine market
  European policy frameworks, vaccine regulation and authorisation, vaccine R&D innovation and introduction, Influenza market sustainability, corporate growth strategies and funding sources

It’s Europe’s premier vaccine event, with over 70 speakers from top pharmaceuticals & biotechs worldwide and representation from key European Commission and regulatory agencies!

Top Speakers:
Dr. Olesen - European Commision
Dr.Lopalco - ECDC
Didier Hoch - President Sanofi Pasteur MSD
Dr. Southerton - Executive Director Pfizer

To see the agenda: Download congress agenda

Broad U.S. Patent Issued for Vaxfectin(R)-Formulated DNA Vaccines for Influenza

Vical Incorporated receives U.S. Patent No. 7,582,613 covering Vaxfectin(R)-formulated DNA vaccines for influenza. The patent provides broad coverage for any circulating or potential influenza viruses, including both seasonal and pandemic strains.

The company is currently developing Vaxfectin(R)-formulated DNA vaccines for both H5N1 avian-origin and H1N1 swine-origin pandemic influenza. Both vaccines are formulated with the company’s Vaxfectin(R) adjuvant, a novel lipid-based formulation which has demonstrated significant immune-enhancing ability with a broad range of DNA vaccines and up to 30-fold immune-enhancing ability with a conventional seasonal influenza vaccine. Vaxfectin(R)-formulated H5N1 influenza DNA vaccines completed Phase 1 human testing in 2008.

DNA vaccines encode certain proteins associated with a target pathogen, rather than using any part of the pathogen itself, and can prime the immune system as well as induce potent antibody and T-cell immune responses. DNA vaccines contain no viral particles, are non-infectious, and can be administered on a repeat basis without unwanted immune responses. Additionally, DNA vaccines have the potential to achieve proof of concept more quickly and cost-effectively than conventional vaccines, and can be manufactured using uniform methods of fermentation and purification, allowing significantly faster development and production.

The new patent broadly covers DNA vaccines formulated with any cationic lipid/co-lipid adjuvant formulations from the class including Vaxfectin(R), and targeting any strain of influenza. It adds to Vical’s family of patents in the United States and other key regions based on the company’s discovery that administering genetic sequences such as DNA or RNA into the body, without the use of viral delivery vehicles, may cause expression of the proteins encoded by the genetic sequences. Vical has additional issued patents covering the composition and use of the Vaxfectin(R) adjuvant.

Chinese Vaccine Makers are Ready to Start Vaccine Production

The Chinese vaccine makers, Sinovac Biotech Ltd. and Hualan Biological Engineering Inc., have completed the clinical trials. Their products are claimed to be effective in single doses for population from three to 60 years. Sinovac claims the annual capacity to produce up to 30 million doses of swine flu vaccine, Hualan claims 160 million doses in a year.

Synthetic Vaccine Platform Presented At Swine Flu Conference

The synthetic vaccine platform technology of Generex Biotechnology Corp. has been presented at the first International Swine Flu Conference in Washington, DC.

Douglas M. Powell, PhD, director of immunobiology at Antigen Express, a wholly owned subsidiary of Generex, described the advantages of suppressing a pandemic virus by next generation vaccines, such as Generex’s synthetic platform, which can be mass-produced using existing technology, more quickly and at lower cost than egg-based vaccines. New synthetic vaccine technology could help prevent infection and easen the severity of H1N1 in humans.

Traditional egg-based vaccines take months to develop and rely on live virus, which always carries the risk of infecting rather than inoculating. Generex’s proprietary synthetic vaccine platform does not use live virus, but instead arranges peptides to create a “snapshot” of the virus that activates the body’s T-cells to fight off the foreign invader, completely eliminating any risk of infection.

Generex’s vaccine platform is already in various stage clinical trials for avian flu, as well as prostate, breast and ovarian cancers, melanomas, SARS and HIV/AIDS.

In addition to the company’s vaccine platform technology, Generex has developed a range of products based on their proprietary RapidMist platform technology for drug delivery through the inner lining of the mouth, ensuring that there is no deposit in the lungs. The company’s flagship product, Generex Oral-lyn is an oral insulin spray product for the treatment of Type-1 and Type-2 diabetes, available to patients in certain overseas markets and in Phase III global clinical trials. Generex has also developed and markets a variety of over-the-counter products.

Pandemic Vaccines: European Market Update

Four ‘mock-up’ vaccines developed by Baxter, GlaxoSmithKline and Novartis have already been approved in the European Union based on earlier data generated with the H5N1 virus strain, which is similar to H1N1. These vaccines were developed in the knowledge that the virus strain would be changed in the event of a declared pandemic, to include the strain causing the pandemic. Altogether, they have been tested in more than 8,000 subjects. Decades of experience with seasonal influenza vaccines indicate that insertion of a new strain in a vaccine, as will apply with the change from H5N1 to H1N1 in the mock-up vaccines, should not substantially affect the safety or level of protection offered.

Approval of the H1N1 vaccine is expected to be given after satisfactory review of these data. Clinical trials with the H1N1 strain are currently being initiated or are ongoing. Initial results on the efficacy, immunogenicity and safety of the vaccine from these trials are expected from September 2009 onwards, and will also be reviewed as soon as they become available.

Flu Vaccine Produces Robust Immune Responses

New vaccine of Vical Incorporated against A/H1N1 pandemic influenza (swine flu) produced robust immune responses well above the accepted protection threshold in 100% of vaccinated mice and rabbits after a standard two-dose vaccine regimen. In addition, at least 75% of vaccinated animals achieved or exceeded the protection threshold after a single dose of vaccine. Vical Incorporated is ready to advance directly to large-scale cGMP manufacturing of the vaccine for human clinical trials, subject to securing external funding for this program.

“Our DNA vaccine technology offers an innovative approach to dealing with pandemics,” said Vijay B. Samant, President and Chief Executive Officer of Vical. “The speed of our platform both in development and manufacturing was demonstrated by our rapid completion of vaccine production and successful immunogenicity testing in animals while conventional vaccine manufacturers are still working toward production of their initial supply of H1 vaccine. We are encouraged by these compelling data with our Vaxfectin(r)-formulated DNA vaccine and we look forward to advancing to human clinical trials as soon as possible.”

Vical’s plasmid DNA vaccine contained the H1 hemagglutinin gene sequence provided by the U.S. Centers for Disease Control and Prevention (CDC) for the A/H1N1 influenza strain selected on April 30. The preclinical vaccine was produced by May 11 and animal testing began on May 15. In two parallel animal studies, one in mice and one in rabbits, vaccine was administered on Day 0 and Day 21, a standard regimen for pandemic influenza vaccines. Sera collected on Day 21, after a single dose of vaccine, showed clear increases over baseline hemagglutination inhibition (HI) titers in 100% of the animals, and HI titers above the protection threshold in 88% of the mice and 75% of the rabbits. Sera collected on Day 35, two weeks after the second dose, showed HI titers well above the protection threshold in 100% of the animals, ranging from 320 to 2,560 (geometric mean titer = 987) in the mice, and from 640 to 2,560 (geometric mean titer = 1,522) in the rabbits. The HI assay measures a vaccine’s ability to prevent viruses from binding to cells, and HI titers of 40 or more are accepted as the threshold for potential protection against influenza viruses. The vaccine encoded H1 hemagglutinin from the swine-origin A/California/04/09 wild-type influenza virus. Vical ran the HI assay against the swine-origin A/California/07/09 x-179a reassortant influenza virus obtained from the CDC.

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.

Flu Vaccine Solution in Spain: VLP Technology

Novavax, Inc. announced initial agreement to license its proprietary, recombinant virus-like-particle (VLP) vaccine technology to ROVI Pharmaceuticals (Madrid: ROVI) of Spain. ROVI will use the VLP technology to create a comprehensive influenza vaccine solution for the Spanish government under a new 60 million euro program sponsored and led by the Spanish Ministry of Health and other government groups to develop pandemic and seasonal flu vaccines and establish its only in-border facility. This program, which was announced today by Spanish health officials, is being launched to develop safe and effective flu vaccines to serve the entire population of Spain.

ABOUT NOVAVAX
Novavax, Inc. (Nasdaq: NVAX) is a clinical-stage biotechnology company creating novel vaccines, including H1N1, to address a broad range of infectious diseases worldwide using advanced proprietary virus-like-particle (VLP) technology.

ABOUT ROVI
ROVI is a fully integrated, profitable Spanish specialty pharmaceutical company engaged in the research, development, in-licensing, manufacturing and marketing of small molecule and specialty biologic drugs.