Norwegian Research Council Names Bionor Immuno "Most Innovative Company of the Year"

Researchers Hope Bionor Immuno's Immune Modulating Investigational Treatment Gives HIV Patients a Safe Break From Anti-Retroviral Therapy


OSLO, NORWAY and BETHESDA, MD--(Marketwire - December 5, 2008) - Bionor Immuno officials today accepted the Norwegian Research Council's prestigious "Most Innovative Company of the Year" award. The award is determined by a panel of 3,500 business leaders who review 10 leading candidate-companies. The results are analyzed by Perduco, a Norwegian-based leader in public and private sector analysis and communication.

"We are enormously proud of this award from the Norwegian Research Council," said Birger Sørensen, President and CEO of Bionor Immuno. "Our pursuit of advances in treatment for patients with HIV and other immune-response related illnesses has stepped into high gear, and on behalf of the researchers, management and staff of Bionor Immuno, we're honored to be recognized."

Bionor Immuno's Unique Approach to HIV Treatment

Based in Oslo with an office in Bethesda, Maryland, Bionor Immuno has an ambitious aim to bring modified peptide-based investigational therapies to market for the treatment of patients with HIV, Hepatitis, and Influenza.

Bionor Immuno currently is recruiting volunteers in the U.S. and in Europe to participate in a Phase IIB clinical trial for its lead HIV therapeutic candidate Vacc-4x. Though frequently referred to as an HIV vaccine, Vacc-4x is being studied for its sustainable therapeutic value in well controlled, HIV positive patients, who, after a series of inoculations with the investigational agent, are able to maintain viral suppression and robust T-Cell counts in absence of their daily anti-retroviral (ART) regimen. Data in earlier clinical trials have shown patients who received Vacc-4x were able to go an average of 31 months off anti-retroviral therapy before restarting a standard ART regimen. For the full appreciation of these unique data, it should be noted that previous experience has shown that ART usually cannot be interrupted for more than 3 to 4 months.

Patients, medical professionals, and researchers seeking more information on the trial should visit http://clinicaltrials.gov/ct2/show/NCT00659789?term=vacc-4x&rank=1.

"This is the largest current therapeutic vaccine trial in the world, involving 345 patients," said Richard Pollard, MD, Chief, Division of Infectious Diseases, AIDS Clinical Trials Unit, Northern California Center for AIDS, University of California, Davis Medical School, and Principle Investigator for the trial. "This trial will establish a solid foundation for HIV immune therapies if we can maintain immunogenicity during drug free periods."

About Vacc-4x Peptide Therapeutic Candidate

Vacc-4x has been tested in two clinical trials exposing the vaccine to 11 and 38 HIV patients, respectively. In both studies the vaccine was found to be safe and well tolerated. In the Phase IIa study comprising 38 patients, the primary objective was to measure immune responses to Vacc-4x. Subjects were initially maintained stable on anti-retroviral therapy while treated over a period of 26 weeks with a series of Vacc-4x immunizations at a low or high dose. This immunization phase included also an ART-free window, or "holiday," during which antigen stimulation was allowed.

--  The majority of volunteers experienced a pronounced therapeutic effect
    allowing them to remain off ART following completion of the study (Week
    52).  While being off ART the patients CD4+ cell counts remained high above
    the level they had before they had ART commenced by their treating
    physician.
--  Due to this pronounced clinical response, permission was granted to
    follow the subjects until they resumed ART.  The median treatment
    interruption achieved for all subjects in the Vacc-4x Phase 2a clinical
    study was 31 months.  The duration of treatment interruption was linked to
    immune responsiveness to the peptides.
--  At a follow up 44 months after treatment interruption, 34 percent of
    the patients were still not back on ART treatment. Previous experience has
    shown that ART usually cannot be interrupted for more than 3 to 4 months.
    

About Bionor Immuno

Bionor Immuno is a biotechnology leader in next generation vaccine design, using a combination of biological data and screening methods with a patented approach to bioinformatics and computational sciences. The Company develops unique synthetic peptide vaccines that stimulate cell mediated immunity. Previous efforts made to utilize T-cell stimulation for vaccines have been notoriously unsuccessful and a new approach is needed. Bionor Immuno carefully designs synthetic (modified) peptides with improved efficacy and safety profiles. Among the diseases targeted by Bionor Immuno researchers are chronic infections caused by HIV, HCV (Hepatitis C), HPV (Human Papilloma Virus) and Influenza. Bionor Immuno's platform technology is universally applicable to a broad range of projects including vaccines targeting common cancer diseases. Bionor Immuno has R&D facilities in Skien, Norway, corporate headquarters in Oslo, and subsidiary based in Bethesda, Maryland. More information is available at www.bionorimmuno.com.

Contact Information: Contacts: Jeff Hackman Bionor Immuno, Inc. Sr. Vice President, Commercial and Business Development 301-571-9395 David Sheon For Bionor Immuno 202-470-2880