Reboost Data Reconfirms 2010 Study

(Oslo, Norway, 28 March 2014)  Bionor Pharma ASA (OSE: BIONOR) announces the results from the Vacc-4x Phase II Reboost trial. The trial explored the effects of Vacc-4x revaccination or reboosting of HIV infected patients that participated in the large 2010 Phase II study.

A further non-statistically significant reduction in mean viral load was observed compared to the set point in the 2010 trial and effect on viral load reduction by Vacc-4x was consequently reconfirmed. The Reboost trial also reconfirms that patients’ ability to respond to Vacc-4x differ and that some patients experience a substantial reduction in viral load. Based on these results it can however not be established whether reboosting is a viable clinical strategy for all patients.

“The trial reconfirmed Vacc-4x’ ability to reduce viral load. In addition to a further reduction of viral load following effect of Vacc-4x revaccination, although not statistically significant, it is gratifying to observe that a subset of study volunteers did experience a considerable reduction in viral load,” said CEO Anker Lundemose MD PhD. “It emphasizes the effect of Vacc-4x in these patients and confirms our focus on ‘responders’ as one of the key components of the future clinical strategy needed for getting Vacc-4x to the market.”

Therapeutic vaccines for infectious diseases are used in patients who already are infected with the goal of reducing or eliminating the circulating virus. The large Phase II 2010 study showed that in subjects that completed a 6 month interruption of anti-retroviral therapy (ART), there was a log 0.44 (64%) reduction in median viral load set point in the Vacc-4x group compared to placebo. The results of this study were published in Lancet Infectious Diseases in February.

“Bionor Pharma’s studies show that therapeutic vaccines remain a potential strategy for managing HIV,” said Richard Pollard, MD, Professor, Chief, Infectious Diseases, University of California Davis. “The understanding of why Vacc-4x appears to work much better in some patients than in others is important in order to offer a new treatment modality to HIV”.

The vaccine was safe and well tolerated. The Reboost study had three serious adverse events (SAE) deemed unrelated to Vacc-4x vaccination.  One SAE was related to study procedure but was fully reversed upon resuming ART.

Bionor Pharma will continue its evaluation and analysis of the data from the study to better understand the patients’ immune response and to explore whether potential biomarkers, e.g. C5 antibodies, are predictive for improved response in this trial. Bionor Pharma expects to submit the results from the trial to an international HIV research conference.

Bionor Pharma continues its pursuit of a functional cure for HIV by exploring the use of Vacc-4x with other agents. A study combining Vacc-4x with the immune stimulator lenalidomide (Revlimid®) is underway, and a trial seeking to kick HIV out of reservoirs prior to vaccination using the HDACi romidepsin (ISTODAX®) will begin shortly. If successful, the Company’s functional cure strategy will enable HIV infected patients to live without disease progression or transmission in the absence of conventional HIV medication ART or in combination with it.

About the Trial
The ReBoost study (NCT01712256) follows on from the large Phase II clinical study (NCT00659789) where the peptide-based therapeutic HIV vaccine candidate, Vacc-4x induced a statistically significant reduction in viral load compared to placebo following interruption of ART.  This study aimed to determine whether viral load could be reduced even further following revaccination of participants that received Vacc-4x in the initial study followed by a second treatment interruption. The study also aimed to compare immune responses generated following reboosting with immune responses observed in the original study as well as the safety and tolerability of re-boosting followed by a second treatment interruption.

A total of 33 volunteers from the Vacc-4x group in the large Phase II study were available to participate the Reboost study. These study participants were localized in 9 clinical trial sites (United States: 2 sites, Germany: 3 sites, Italy: 1 site, UK: 1 site and Spain: 2 sites). The immunization schedule involved two booster immunizations of Vacc-4x using granulocyte-macrophage colony stimulating factor (GM-CSF) as a local adjuvant 2 weeks apart. Subjects remained on ART for 10 weeks prior to treatment interruption for up to 16-weeks. Following ART resumption, participants were followed for another 8 weeks. Three of the subjects were off ART at enrolment and carried out the study while off ART. The entire study period for each participant was 37 weeks. The first participants were enrolled in January 2013. Enrolment was completed in April 2013 and the study concluded in January 2014.

Bionor Pharma ASA
CEO Anker Lundemose Tel +47 23 01 09 60
CFO Synne H Røine Tel +47 99 22 98 92

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

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.

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).