OSLO, NORWAY--(Marketwire - July 09, 2012) -
Bionor Pharma ASA (OSLO: BIONOR) announced today that the Research Council of Norway through its GLOBVAC program (for Global Health and Vaccine Research) has awarded Bionor US$1.7 million (NOK 10.48 mill.) to help fund a study that researchers hope will lead to a better understanding of how Vacc-4x can contribute to an eradication strategy for HIV. Bionor is the only company from Industrial Sector approved for funding.
The grant is titled "Towards Eradication of HIV-1: Therapeutic Vaccination with the peptide-based candidate Vacc-4x."
The award will help fund a multinational study to "reboost" patients from the previously conducted phase IIb study with Vacc-4x. The aim of the new study is to see if additional vaccinations, over time, can further reduce viral load while patients are not on conventional HIV medicine (antiretroviral therapy, ART).
A New Strategy to Eradicate HIV
ART is not a cure, and the treatment can cause serious side effects. ART does not kill virus producing cells, and it blocks virus production only while patients take the medication. ART must therefore be a daily, lifelong treatment. In contrast, Vacc-4x is developed to provide long lasting virus control by training immune cells to seek out and kill virus-producing cells, without any serious side effects.
"We appreciate this support from the GLOBVAC program at the Research Council of Norway," said Maja A. Sommerfelt, SVP, Chief Scientific Officer, Bionor Pharma. "This funding will help to determine Vacc-4x's potential to contribute to the future management of HIV infection and to improve global health."
"If the reboost study shows that Vacc-4x offers further reduction of viral load through additional vaccinations, doctors and patients may have a new weapon to fight the epidemic of HIV," said Richard Pollard, MD, Chief of Infectious Diseases, University of California-Davis. Dr. Pollard serves as member of Bionor's Clinical Advisory Board.
In addition to the reboost study, the funding will also cover the cost of a smaller study of an adjuvant used together with Vacc-4x, required by FDA (Food and Drug Administration) as part of Bionor's path to marketing clearance for Vacc-4x.
Bionor's Research Further Supported by Private Placement
The Company has a comprehensive clinical and preclinical program and will use the proceeds from the Private Placement 14 June of approx. US$10 million to fund these programs, for general business purposes and to strengthen the Company's balance sheet. The placement was oversubscribed. The Company's cash position is, following the fundraising, approx. US$25 million/NOK 150 mill. With current burn rate, this is sufficient to cover the company's operation through 2014.
Bionor's Research Program Presented at International Conferences
BIO conference in the US, June 2012: Bionor leadership presented a summary of its research findings at the BIO 2012 conference in Boston, 20 June.
AIDS 2012 in Washington D.C., July 2012: Bionor researchers will be presenting the latest immunological analysis of the Vacc-4x phase IIb data at the IAS (International AIDS Society) Cure Workshop linked to AIDS 2012, Saturday, 21 July.
Research Council of Norway's Programme for Global Health and Vaccine Research, GLOBVAC, supports research that can contribute to sustainable improvements in health and health equity for people in low- and middle-income countries.
The program has a wide scope, and gives highest priority to projects in the following thematic areas:
1. Vaccine and vaccination research;
2. Health systems and health policy research;
3. Innovation in technology and methods development;
4. Implementation research.
The annual budget of the GLOBVAC program is currently NOK 60.8 mill. (US$11.3 million).
About Bionor Pharma ASA
Bionor Pharma is a leading vaccine company, listed at Oslo Stock Exchange. The Company's investments in developing therapeutic vaccines exceed US$70 million.
Bionor's vaccines are based on the proprietary technology platform developed following more than two decades of research on peptides. The vaccines are designed to safely stimulate each person's immune system to combat viral diseases. The Company's lead HIV vaccine, Vacc-4x, is being investigated as a therapeutic vaccine, and has completed a phase 2b randomized, multinational (USA and 4 European countries), double-blind, placebo-controlled trial. It produced a statistically significant reduction in viral load and viral load set point (stabilized viral load) by killing of virus producing cells.
Bionor's second therapeutic HIV vaccine, Vacc-C5, is developed to induce antibodies to HIV that can reduce viral production (lowering the set point) and the harmful hyperactivation of the immune system that leads to AIDS. Recently, the clinical phase I/II study with Vacc-C5 was approved by the Norwegian Regulatory Authorities. Subsequent to the Vacc-C5 phase I/II trial, Bionor intends to combine Vacc-4x with Vacc-C5, which could form the basis for both a therapeutic and a preventive HIV vaccine.
The Company's innovative technology platform is also well suited to develop vaccines for other viral diseases, including Influenza, HCV (Hepatitis C), CMV (Cytomegalovirus) and HPV (Human papillomavirus). Vaccines for Influenza (Vacc-Flu) and HCV (Vacc-HCV) are in preclinical phase of development.
More information about Bionor Pharma, its research and products, is available at www.bionorpharma.com.
This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act). Vacc-4x, Vacc-C5, Vacc-Flu, Vacc-HCV, Vacc-CMV and Vacc-HPV are investigational treatments that have not been approved for marketing by any regulatory authority.