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First Evidence that Romidepsin “Kicks” HIV out of Reservoirs

Results from Part A of Bionor Pharma’s REDUC study Presented at the 2014 AIDS Conference and IAS’ HIV Cure Symposium

(Oslo, Norway, 22 July 2014)  Bionor Pharma ASA (OSE: BIONOR) announces that data from part A of the REDUC study has been presented at the 2014 International AIDS Conference in Melbourne, Australia. The topline results from Part A of the REDUC trial were reported to the Norwegian Stock Market on 12 May 2014. REDUC Part A demonstrated that the HDAC inhibitor (HDACi) romidepsin is able to activate latent HIV reservoirs.

"It is the first time that it is demonstrated that romidepsin can reactivate latent HIV reservoirs in HIV infected persons,” said Professor Lars Østergaard, Aarhus University Hospital, Principal Investigator of the study. “The fact that reactivation of the reservoirs also leads to detectable viral load levels in plasma is very promising for the key objective of REDUC which is exploring the reduction of the reservoirs by Vacc-4x vaccination followed by romidepsin activation,” continued Professor Lars Østergaard.

The objective of REDUC part A was to assess the safety and effect on HIV transcription of the chosen romidepsin dose. Six patients received three infusions with 5mg/m2 of romidepsin. The treatment successfully reactivated HIV transcription in all 6 patients within a few hours following each romidepsin administration followed by a decrease between day 3 and 7 day post-infusion.

Romidepsin treatment in the 5mg/m2 dose was found to be safe; the incidence and severity of adverse events (all grade 1-2) were consistent with the known side effects of romidepsin and HDACi in general.

The pharmacodynamic effect of romidepsin on cellular chromatin organization was evaluated by measuring levels of histone H3 acetylation. H3 histone acetylation was found to increase rapidly (max 17.7 fold relative to baseline) within the first hours following each romidepsin administration and then decreased between day 3 and 7 day post-infusion.

Two separate virological measures were applied to assess the effect on HIV-1 production.  The level of HIV-1 transcription, defined as cell-associated unspliced (CA-US) HIV-1-RNA, was found to increase significantly from baseline during treatment (2.1-3.9 fold after 2nd infusion; p=0.03). Levels of plasma HIV-1 RNA increased from undetectable at baseline to quantifiable levels post-infusion in 5 of 6 patients (range 46-103 copies/mL after 2nd infusion, p=0.035).

The objective of the ongoing part B of the REDUC trial is to investigate whether combination treatment with Bionor Pharma’s therapeutic vaccine candidate Vacc-4x followed by romidepsin infusion impacts the latent HIV reservoir. Researchers refer to this approach as a “Kick-kill” strategy, where the HDACi is used to “kick” the virus out of reservoirs making the HIV infected cells visible to the immune system. This should allow the immune response generated by Vacc-4x to attack and eliminate the infected cells. Conventional HIV medication, cART is unable to eliminate the virus residing in latently infected cells.

Enrollment of patients for part B started in Q2 2014 and reservoir data is expected in H1 2015 whereas topline results are expected in H2 2015. 

About the REDUC study
The REDUC study investigates 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 established the optimal dose of Istodax® based on safety and the effect on the latent HIV reservoir. The second phase will include vaccination with Vacc-4x followed by treatment with Istodax® once a week for three weeks. Patients will then undergo a monitored antiretroviral treatment pause. During this period the control of HIV replication in the absence of cART 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.

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

Bionor Pharma ASA
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