First Human Clinical Study of HIV Vaccine Vacc-C5 Approved to Begin

OSLO, NORWAY--(Marketwire - May 29, 2012) - Bionor Pharma ASA (OSLO: BIONOR)

News Summary

• Open, clinical study, dose escalating, phase I/II, with Bionor Pharma's second therapeutic HIV vaccine to begin at Oslo University Hospital.
  
  
• Researchers hope Vacc-C5 will prevent hyperactivation of immune system that leads to AIDS, and possibly thereby make patients able to control HIV replication without the need for medication.
  
  
• The study will investigate whether humans develop antibodies to HIV as a result of vaccination with Vacc-C5, and if these antibodies have same properties as antibodies found in "long term non progressors," in other words patients who live with HIV but are able to naturally suppress the virus.
  

Bionor Pharma ASA (OSLO: BIONOR) announced today that the first study of Bionor Pharma's Vacc-C5 is now approved to begin at Oslo University Hospital. Vacc-C5 is a therapeutic HIV vaccine developed to slow down or stop induction of immune hyperactivation, a feature that drives the production of HIV and is damaging the immune system, leading to AIDS. Vacc-C5 also may have the potential to be a preventive vaccine, alone or in combination with Vacc-4x.

The phase I/II study will use Vacc-C5 at three different dose levels, in order to evaluate safety and provide a determination for the optimal dose of the vaccine, when given intradermally (in the skin) or intramuscularly.

"The pre-clinical studies of Vacc-C5 in rabbits, and sheep, as well as data confirming an association between high antibody levels and slow progression of HIV in humans have generated considerable interest," said Dag Kvale, MD, PhD, Principal Investigator at Oslo University Hospital. "We look forward to see how people living with HIV respond when on Vacc-C5."

The study seeks to recruit 36 patients who have been infected with HIV for at least one year. Study participants must have been stable on antiretroviral therapy (ART, traditional HIV medicine) for at least six months with a viral load of less than 50 copies per milliliter. The primary endpoint of the trial is to evaluate safety of the vaccine at three different dose levels. Secondary endpoints include measuring specific antibody and T-cell responses to Vacc-C5 and to evaluate T-cell activation markers. Vacc-C5 will be given in combination with two different adjuvants, (that enhance the immune response), either GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) or Alhydrogel (an aluminum-based treatment).

How Vacc-C5 is considered to Work, in Comparison to Vacc-4x
Vacc-C5 generates antibodies based on modified, manufactured (synthetic) peptides from the C5 region (of gp 120) at the HIV-virus surface. Data suggest that anti-C5 antibodies may play a crucial role for Natural Viral Suppressors, a group of people who are able to control the HIV infection without the need of HIV medication.

Bionor Pharma has filed a patent application covering Vacc-C5.

The further strategy is to use Vacc-C5 in combination with Vacc-4x since Vacc-4x already has via T-cell (killer cell) responses shown to lower the viral load set point (stabilized virus level) by statistically significant levels compared to placebo.

"Where Vacc-4x appears to kill virus-producing cells, Vacc-C5 has the potential to reduce the damaging immune activation," said Birger Sørensen, EVP Head of Vaccines. "Looking ahead, we're very excited to study the two vaccines in combination, pending that safety and dosing are confirmed in this trial."

Bionor plans on studying the two treatments Vacc-4x and Vacc-C5 in combination.

Objectives and indications
Vacc-C5 has potential both as part of a preventive vaccine, and as a therapy, by preventing or reversing immune collapse in chronically infected patients.

Researchers believe the antibodies induced by Vacc-C5 can be beneficial at all stages of HIV infection by slowing down or halting the disease progression, and by significantly reducing the production of virus.

Theoretically, Vacc-C5 could be used at any point in patient treatment, forming a part (together with Vacc-4x) of both therapeutic and preventive therapy:

1. Treatment of existing patients at risk of immune collapse

• Newly infected patients
• Patients developing treatment-resistant HIV strains
• Patients intolerant of existing therapies

2. As a preventative vaccine for high risk populations

Early Research Provides Clue to New Strategy for HIV Management
Bionor Pharma started its research on Vacc-C5 by testing blood samples from HIV-infected patients. These demonstrated significant antibody reactivity to Vacc-C5 in blood from Natural Viral Suppressors.

The study was performed in collaboration with Professor Robert Redfield at the University of Maryland, Baltimore, USA, using ELISA tests on blood samples from a total of 57 HIV-infected patients, of which 43 were HIV natural viral suppressors with very low viral load. Reactivity to Vacc-C5 was significantly greater in these patients compared to patients with medium/high viral load. The study showed statistically significant difference in reactivity towards Vacc-C5 between the two groups (p=0,018).

This study confirms that antigens identified previously by the Company are directly associated with the antibodies of Natural Viral Suppressors. The immunogenicity of Vacc-C5 has recently also been confirmed in animal studies.

These studies received partial funding from the Research Council of Norway.

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 activate each person's immune system to combat viral diseases.

HIV/AIDS
Global leader in developing HIV vaccine: The Company's lead investigational product, the therapeutic HIV vaccine Vacc-4x, has in a completed phase IIb multinational (USA, Germany, UK, Spain and Italy), placebo controlled, double-blind study, shown a statistically significant reduction in viral load.

Step towards long lasting HIV viral control with Vacc-4x: Conventional HIV medication (antiretroviral therapy, ART) is not a cure, but blocks virus production only while patients take this medication. ART must therefore be a lifelong treatment. In contrast, Bionor Pharma's therapeutic vaccine aims to induce long lasting virus control by training immune cells to seek out and kill virus-producing cells. The observed 64% CTL induced reduction (reduction by killer cells) in viral load set point in patients who received Vacc-4x compared to placebo in the phase IIb study therefore represents a step towards long-lasting viral control. Because most patients who are given ART are known to stop taking it for various reasons (high costs, limited access, development of resistance, and serious adverse events), Bionor believes Vacc-4x could be a vital treatment option that can stabilize patients if they stop taking ART. HIV vaccine inducing antibodies: 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. 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 preventative vaccine.

Global HIV challenge: According to the UN organization UNAIDS, 34 million people were living with HIV in 2010. Approximately three million new people are infected annually. Only one out of six HIV-infected patients currently has access to ART treatment. According to recent CDC studies, less than 25 percent of people prescribed conventional HIV medicine stay on the treatment.

Pharmaceutical sales to treat HIV are US$ 10.6 billion (NOK 63 billion) annually, and treatment cost per patient is approx. US$ 15,000 (NOK 90,000) per year.

Pathways to market for Bionor Pharma's HIV vaccines

Bionor researchers will investigate various independent pathways to market for the HIV vaccine candidates Vacc-4x and Vacc-C5, through further clinical studies starting this year:

1. Vacc-4x revaccination in patients who participated in the phase IIb study, with the aim of reducing viral load even further by killing of virus producing cells.

2. Vacc-4x combined with Revlimid® (lenalidomide), in patients with a weakened immune system which does not recover despite being seemingly well controlled on ART.

3. Vacc-C5 clinical trial phase I/II, to document whether Vacc-C5 increases HIV antibodies in humans. The company aims to subsequently study Vacc-C5 in combination with Vacc-4x, a treatment that potentially can eradicate and prevent HIV and thereby revolutionize HIV treatment.

Nasal administration of Vacc-4x: A placebo controlled study with Vacc-4x at Oslo University Hospital demonstrated safety and successful immunization in treated patients by nasally delivered vaccine. This option may offer easier treatment access for HIV patients globally. Further analyses are ongoing, and will be published at a later stage.

VACCINES FOR OTHER VIRAL DISEASES
The Company's innovative technology platform is also well suited to develop vaccines for other viral diseases, such as Influenza, HCV (Hepatitis C), HPV (Human Papilloma Virus) and CMV (Cytomegalovirus).

Vacc-Flu (Universal Influenza vaccine) and Vacc-HCV (Hepatitis C vaccine) 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-C5 and Vacc-4x are investigational treatments that have not been approved for marketing by any regulatory authority.