Results of the REDUC study Part A published in the journal PLoS Pathogens

(Oslo, Norway, 18 September 2015) Bionor Pharma ASA (Bionor) (OSE:BIONOR), a peptide vaccine company advancing a potential first therapeutic vaccine towards a functional cure for HIV, today announces the publication of the manuscript “The Depsipeptide Romidepsin Reverses HIV-1 Latency in vivo” in the peer-reviewed journal PLoS Pathogens. Ole Schmeltz Søgaard from Aarhus University Hospital in Denmark is corresponding author of the manuscript, which describes the results from Part A of the Bionor sponsored REDUC study presented at the IAS 2014 conference in Melbourne.

Until now, approaches to kick HIV out of latent reservoirs in humans have yielded mixed results. This manuscript reports Part A of a proof-of-concept phase Ib/IIa clinical trial where 6 HIV infected adults, well controlled on antiretroviral therapy, received intravenous doses (5 mg/m2) of Celgene’s HDAC inhibitor, romidepsin (Istodax®), once weekly for 3 weeks. Romidepsin safely increased the level of virus measured in the blood stream such that it became readily detectable using standard commercial assays.

Ole Schmeltz Søgaard commented:“The results show that romidepsin treatment can lead to the release ofHIVparticlesfrom latent reservoirs into the blood stream of HIV infected patients on anti-retroviral treatment. This representsan important step forward on the path towards a combination strategy that will significantly impact the size of the latent reservoir.

David H. Solomon, President and CEO, commented:“The publication of the REDUC Part A results in a peer-reviewed journal shows the importance of Bionor’s therapeutic vaccine approach to a functional cure for HIV. We are also excited that the interim results of Part B of the study with Vacc-4x and romidepsin in combination are so intriguing, and we look forward to reporting the top line results of the study later this year.” 

Background
HIV remains a global healthcare problem with significant cost burden. Finding a functional cure for HIV, including a therapeutic vaccine is high on the global medical community and regulatory agenda.

Current standard of care of HIV infection consists of combination antiretroviral therapy (cART), which, for those receiving cART, changes HIV from a terminal disease to a controllable chronic infection. In 2013, approximately 36 million people were living with HIV, an increase of 17% from 2001. While cART effectively reduces viral load, it does not cure HIV, and it must be taken daily for life. If cART is discontinued, viral load rebounds rapidly as the treatment does not eliminate the latent viral reservoirs. In addition, due to the cost of treatment, cART is not globally available.

In this context, Bionor is well positioned with Vacc-4x, one of the most advanced therapeutic vaccines in HIV care. Bionor’s principal strategy is to advance Vacc-4x in combination with other medicines, including latency reversing agents, in order to develop a functional cure for HIV. In its interim financial report for the first half of 2015, Bionor reported promising interim Phase II results and started the preparation for an international, multicenter proof of concept Phase II clinical study for Vacc-4x as a component in a functional HIV cure.

Further information
David H. Solomon, President and CEO, +45 22 20 63 00, dhs@bionorpharma.com
Jørgen F. Ravn, VP Investor Relations & Communications, +45 20 30 39 03, jfr@bionorpharma.com

About the REDUC trial
The REDUC trial studies the combination of the HDAC inhibitor romidepsin (Istodax®) and Vacc-4x in HIV patients on combination antiretroviral therapy (cART). The first phase of the study (Part A) assessed the safety and effect on HIV transcription of the chosen dose of romidepsin. The second phase (Part B) includes vaccination with Vacc-4x followed by treatment with romidepsin once a week for three weeks. Patients then have a protocol specified cART treatment interruption of up to 18 weeks. During this period without cART the control of HIV replication will be evaluated to see if the viral load continues to be suppressed by the immune system. Bionor Pharma is the study sponsor. The Department of Infectious Diseases, Aarhus University Hospital, Denmark with Lead investigator Professor Lars Østergaard is conducting the study. The study is partly funded by the Research Council of Norway GLOBVAC program.

About Bionor
Bionor Pharma is a Norwegian biopharmaceutical company advancing a potential first therapeutic vaccine for human immunodeficiency virus (HIV), which, if left untreated, causes acquired immunodeficiency syndrome, (AIDS), in humans. Bionor Pharma has first mover potential to use its therapeutic vaccine, Vacc-4x, in combination with other medicines, as part of a functional cure for HIV. Vacc-4x has demonstrated a reduction of viral load in a large, randomized, controlled Phase II trial, as well as safety and tolerability. Bionor’s current clinical focus is to explore whether Vacc-4x, used with other medicines as a combination therapy, can reduce the viral load even further, and the company, through collaboration with Celgene, is investigating Vacc-4x and the HDAC inhibitor romidepsin in the REDUC study.  Bionor is headquartered in Oslo, Norway, and is listed on the Oslo stock exchange, under the ticker BIONOR. More information about Bionor is available at www.bionorpharma.com.

PDF of the press release