VaxInnate's Second Flu Vaccine Candidate Enters Clinical Development; Results Expected In Early 2009

Main Category: Flu / Cold / SARS
Also Included In: Immune System / Vaccines;  Pharma Industry / Biotech Industry
Article Date: 01 Oct 2008 - 10:00 PDT

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VaxInnate Corporation, a biotechnology company pioneering breakthrough technology to develop novel seasonal and pandemic influenza vaccines, today announced that its second influenza vaccine candidate has entered clinical development.

The Phase I study is expected to yield important information about the safety and immunogenicity - or ability to generate an immune response -- of VaxInnate's hemagglutinin (HA)-flagellin flu vaccine candidate. The study is taking place at the University of Rochester in New York. Results are expected in early 2009.

The HA vaccine candidate links the hemagglutinin (HA) antigen, which has been the key protective component in flu vaccines for many years, to flagellin, a bacterial protein that interacts with the immune system's toll-like receptors (TLRs) to enhance the vaccine candidate's immunological potency. The vaccine candidate is produced by recombinant expression in bacteria using VaxInnate's proprietary manufacturing technology.

"The advance of VaxInnate's second vaccine candidate into clinical development is an important milestone in our comprehensive flu vaccine development program," said CEO Alan Shaw, PhD. "This is a critical first test of our HA vaccine candidate, which has the potential to be a highly effective, less expensive and more efficiently produced alternative to current flu vaccines, whose shortcomings have handicapped our ability to address seasonal and potential pandemic flu."

The open-label, escalating, dose-ranging study includes 56 healthy adult volunteers aged 18-49 years who are receiving a single intramuscular dose ranging from 0.1 ug to 8 ug of vaccine candidate. There will be six months of follow-up after administration of the vaccine candidate.

"We believe VaxInnate's approach to flu vaccine development has a great deal of promise and look forward to learning more about the potential of the HA flu vaccine candidate in this first clinical trial," said John Treanor, MD, primary investigator of the study.

Dr. Treanor, who has a long standing interest in influenza pathogenesis and vaccine development, is also Professor of Medicine and Professor of Microbiology and Immunology at the University of Rochester School of Medicine and Dentistry.

VaxInnate's Approach and the HA Vaccine Candidate

In developing traditional flu vaccines, epidemiologists must predict months in advance which flu strains will be circulating during the next fall/winter season in order to formulate a vaccine that targets the likeliest candidates. That's because hemagglutinin (HA), a vaccine antigen that has been used in flu vaccines for many years, changes over time, in turn forcing manufacturers to change the strains of HA used in seasonal flu vaccines.

The selected flu strains are then manufactured in live, fertilized chicken eggs using a laborious process that takes 6 to 9 months. Federally-funded alternative approaches now in development, such as cell-based production, also take 6 months and require sizable, committed manufacturing facilities for large-scale vaccine production.

Using either of these means of production, the time necessary to produce flu vaccine makes it difficult to respond to public health emergencies, such as the emergence of a pandemic flu, and virtually impossible to reformulate vaccine should circulating strains not match those in the seasonal vaccine, as was the case during the 2007-2008 flu season. Difficulties in growing virus strains have also resulted in vaccine shortages early in flu season, when most vaccination takes place.

Unlike egg- or cell-based vaccine production, VaxInnate's technology is based upon the expression in recombinant bacteria of relevant influenza virus protein antigens - in this case, HA -- fused to the bacterial protein flagellin. Flagellin interacts with the immune system's toll-like receptors (TLRs), which function in human immune cells like sentries to detect pathogens and trigger a general immune defense. This initial defense releases cytokines and other signals that in turn stimulate a second, stronger adaptive immune response, including production of pathogen-specific antibodies.

This new technology could produce highly potent influenza vaccine that can be rapidly and inexpensively produced in volumes sufficient to meet national and global needs, and be suitable for stockpiling.

About VaxInnate

VaxInnate is a privately-held biotechnology company in Cranbury, NJ and New Haven, CT that is pioneering breakthrough technology for use in developing novel, proprietary vaccines for seasonal and pandemic influenza. This technology has the potential to dramatically improve the potency, manufacturing capacity and cost-effectiveness of influenza vaccines.

In addition to the HA flu vaccine candidate in clinical development, VaxInnate is on track both to begin a Phase II study of its M2e universal influenza vaccine candidate and to advance a vaccine candidate for H5 avian influenza virus - the most likely parent of a new pandemic strain -- into clinical development in 2009.

Positive findings from a Phase I clinical trial of VaxInnate's universal flu vaccine candidate will be presented at next month's joint Interscience Conference on Antimicrobial Agents and Chemotherapy/Infectious Diseases Society of America (ICAAC/IDSA) meeting in Washington, DC.

VaxInnate's technology platform is also being investigated for development of vaccines for other diseases. For more information about VaxInnate, please visit http://www.vaxinnate.com.