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Patient Enrollment Completed in Bionor Pharma’s First Human Clinical Study of the HIV Vaccine Vacc-C5

Oslo 27.05.2013 - Bionor Pharma ASA (OSE: BIONOR) announced today that patient enrollment in the first clinical study of its second HIV vaccine, Vacc-C5, is now completed, with 36 HIV infected patients enrolled at Oslo University Hospital.

Thirty six HIV Patients Participate at Oslo University Hospital
Vacc-C5 has been developed with the aim to induce antibodies to HIV that can potentially reduce the harmful hyperactivation of the immune system which likely leads to AIDS.  Antibody responses to Vacc-C5 have already been demonstrated in preclinical studies. First results (interim data) may become available in 2013. We expect to release data from this study in Q1 2014.

About the Vacc-C5 phase I/II study
Study design: Open, clinical, dose escalating, phase I/II study with 36 patients who have been HIV infected for at least one year. Study participants must have been stable on conventional HIV medication (antiretroviral therapy, ART) for at least six months with a viral load of less than 50 copies per milliliter. Vacc-C5 will be given at three different dose levels in combination with two different adjuvants which enhance the immune response. The study period is 26 weeks for each patient, and treatment of patients will be finalized by end of November 2013.

Primary objective: To evaluate safety of the vaccine at three different dose levels in combination with two different adjuvants.

Secondary objective: Measuring antibody responses to the vaccine.

Aim of the study: In addition to evaluating safety, 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.

Vacc-C5 works in a complementary way to Bionor Pharma’s first clinical HIV vaccine, Vacc-4x
Vacc-C5 serves to prevent the immune activation that drives HIV disease progression, whilst Vacc-4x aims to induce long lasting virus control by training immune cells to seek out and kill virus-producing cells. Therefore, the combination of Vacc-C5 and Vacc-4x (Vacc-HIV) could act synergistically and contribute to a functional cure strategy for HIV, meaning that people can live long-term with no HIV replication or disease progression in the absence of ongoing antiretroviral therapy. Vacc-HIV could also potentially contribute to a preventive vaccine strategy.  Bionor Pharma is currently preparing Vacc-HIV for a preclinical study.

Bionor Pharma ASA

Hilde Aalling Syvertsen,
-Director Communications & Corporate Affairs 

Tel +47 23 01 09 60

About Bionor Pharma ASA
Bionor Pharma is a leading biotechnology company, searching for breakthrough products for the treatment and prevention of life-threatening viral diseases. The Company is listed on the Oslo Stock Exchange, and is developing vaccines for viral infections. The vaccines are based on a proprietary technology platform developed following more than two decades of research into peptides, and they are designed to safely stimulate the immune system to combat viral diseases.

Global leader in the development of HIV vaccines
The Company has a leading position in the global research field for therapeutic HIV vaccines, and has two vaccine candidates in the clinical stage of development: Vacc-4x aims to induce long lasting virus control by training immune cells to seek out and kill virus-producing cells, and Vacc-C5 is designed to induce antibodies to HIV that can reduce the harmful hyperactivation of the immune system which can lead to AIDS. The foremost candidate, Vacc-4x, has shown a statistically significant reduction in viral load in a phase II randomized, multinational, double-blind, placebo-controlled study. The Company’s innovative technology platform is also well positioned to develop vaccines for other viral diseases, such as Influenza, HCV (Hepatitis C), HPV (Human papillomavirus) and CMV (Cytomegalovirus).

Four vaccine candidates in development
HIV vaccine, Vacc-4x: 1. Clinical phase II study, combining Vacc-4x with Celgene’s immune modulator Revlimid® (Lenalidomide), to investigate whether Revlimid enhances the effect of Vacc-4x in this placebo-controlled study in HIV patients with an impaired immune system.
2. Clinical phase II study, with Reboost in patients from the previous phase II study, aimed at reducing viral load even further.

HIV vaccine, Vacc-C5: Clinical phase I/II study, to investigate safety and whether the vaccine induces antibodies against HIV in humans.

HIV vaccine, Vacc-HIV (combination of Vacc-4x and Vacc-C5): A preclinical study is in preparation. The rationale behind Vacc-HIV is that this combination should prove more efficacious than each vaccine individually.

Universal influenza vaccine, Vacc-Flu: This vaccine is in the preclinical phase of development. Vacc-Flu is designed to produce long lasting immunity, and to be effective against all seasonal variations of influenza A.

More information about Bionor Pharma is available at www.bionorpharma.com

This information is subject to the disclosure requirements of §5-12 vphl
(Norwegian Securities Trading Act).  Vacc-4x, Vacc-C5, Vacc-HIV, Vacc-Flu, Vacc-HCV, Vacc-CMV and Vacc-HPV are currently investigational treatments that have not been approved for marketing by any regulatory authority.