Bionor Pharma's Universal Influenza Vaccine, Vacc-Flu, Targets Regions Shared by All Influenza A Strains; Reduces Serious Flu Symptoms by 25 Percent Over Standard Flu Vaccine in Animal Study

ARLINGTON, VA--(Marketwire - Nov 22, 2011) -

Summary of Findings

• Bionor's Vacc-Flu could be "Universal," meaning that it could work on seasonal flu and also on known pandemic flu strains such as Swine or Avian flu and well as new pandemic strains that may appear in the future.
• Researchers designed Vacc-Flu to work by targeting conserved domains, the regions of the virus common to all known influenza A. Only Influenza A can lead to pandemics. The vaccine aims to stimulate both arms of the immune system.
• Mice vaccinated with Vacc-Flu showed 25 percent better protection from the most serious effects of influenza virus infection above the protection from a standard influenza vaccine.
• There is no universal flu vaccine. Vacc-Flu is the only candidate known to target both arms of the immune system.
• The study was conducted in collaboration with St. Georges, University of London and the Norwegian Institute of Public Health.

Researchers from Bionor Pharma (OSLO: BIONOR) presented new data on the Company's universal influenza vaccine candidate at the recent Influenza Congress USA in Arlington, Virginia. The vaccine targets conserved domains, or the Achilles Heel common to all known Influenza A viruses, and could provide protection against seasonal flu and other pandemic influenzas such as Swine flu.

The vaccine is designed to provide long-term protection over several years, reducing deaths and related illnesses caused by all current influenza A subtypes, as well as future influenza viruses that may emerge and lead to an influenza pandemic.

Regions common to all Influenza A identified
Current influenza vaccines are virus specific and are less effective when the virus changes, or "drifts," over time. Seasonal vaccines include a mixture of different viruses anticipated to circulate in a given season. Bionor researchers have identified conserved domains of Influenza A, located on the proteins M2 and NP that are common to all known virus variants of influenza A. These regions have been the basis for generating peptides that are modified to improve their ability to stimulate the immune system. Bionor's use of modified peptides for the development of a universal influenza vaccine was reported for the first time at this conference.

"Because Bionor initially developed diagnostic tools for viruses, we have extensive experience on finding conserved domains because that is the roadmap for finding a way to identify a virus in large numbers of people," said Birger Sørensen, EVP Vaccine Development, Bionor Pharma. "Now we have analyzed over 20,000 protein sequences from Influenza A viruses in man, birds and mammals -- swine and horses -- to identify regions that are preserved and are common to the various carriers of influenza."

Finding a "Universal" Influenza Vaccine
Researchers have never found a "universal" influenza vaccine because Influenza viruses undergo constant genetic mutation, or "antigen drift." When a cell is infected with two different influenza strains there is potential for a new virus that has a mixture of segments from both parent viruses, resulting in an antigenic "shift." As a result of poor immunity to this new "re-assorted" virus, a pandemic can arise. Such was the case with the Swine flu pandemic in 2009, which had its origins in influenza viruses combined from humans, birds and pigs.

"The benefits of a Universal Vaccine far outweigh the current seasonal vaccine development approach," said Steen Krøyer, CEO, Bionor Pharma. "The goal is to eliminate the need for researchers to develop annual vaccines, a challenging process that requires manufacturers to operate on a tight schedule to meet WHO recommendations."

The global market for an influenza vaccine is approximately 250 million doses corresponding to annual sale of approximately $2 billion to $2.7 billion. Today's influenza vaccines are specific only for one season and new vaccines have to be developed each year.

About the Study
The animal study data was presented at the Influenza Congress USA by Dr. Maja Sommerfelt, SVP and Chief Scientific Officer. Mice were immunized with Vacc-Flu and as a control, swine flu virus particles that had been inactivated was used as a conventional vaccine.

The mice were then challenged with a different strain of influenza virus (PR8) to more closely mimic what happens when circulating strains do not match the vaccine. Mice vaccinated with Vacc-Flu showed 25 percent better protection from the most serious effects of influenza virus infection above the conventional influenza vaccine. The study was conducted in collaboration with St. Georges, University of London and the Norwegian National Institute of Public Health.

About Vacc-Flu
Vacc-Flu consists of synthetic modified peptides based on conserved regions on the influenza virus. The peptides are modified to enhance their ability to stimulate the immune system. Bionor Pharma researchers designed vaccine-suitable peptides -- small proteins created synthetically, modified to generate effective antigens that stimulate cell-mediated and humoral immunity.

Peptides offer numerous advantages as antigens, including cost-effective large scale production, synthetic (thus eliminating the need to grow large levels of potentially dangerous virus), elimination of egg allergy concerns, and the ability to re-boost immunity.

About Bionor Pharma
Bionor Pharma is a biopharmaceutical company based in Oslo, Norway. The Company's lead investigational product, HIV therapeutic vaccine Vacc-4x, has completed a Phase IIB multinational, placebo controlled double-blind trial. The Company's innovative technology platform is also well suited to the development of vaccines for a wide range of other viral diseases, such as hepatitis C (HCV) and cervical cancer (HPV - human papilloma virus) in addition to HIV and influenza.

Bionor's vaccines are based on the proprietary technology platform developed following several years of research on peptides. The vaccines are designed to safely activate each person's immune system to combat viral disease.

Bionor seeks to create positive cash flow at an early stage of development by signing partnering deals with biotechnology and pharmaceutical companies. This includes short-term out-licensing of products with royalty payments or direct funding of clinical trials, such as Bionor's agreement signed in August 2011 with one of the world's largest Biotech companies. The collaboration includes a clinical trial on patients with HIV using a combination of Vacc-4x, and the cancer drug Revlimid®.