Bionor announces that the HIV �Shock & Kill� trial REDUC with Vacc-4x and romidepsin meets its primary endpoint by significantly reducing latent HIV reservoir and demonstrates control of viral load.

Bionor Pharma ASA, a biopharmaceutical company focused on advancing a functional cure for HIV announces successful results of the REDUC Part B clinical trial . In the REDUC trial, the combination of Vacc-4x and the latency reversing agent romidepsin (Istodax, Celgene) leads to control of reactivated HIV and reduction in latent viral reservoir, and the trial results confirm and extend the positive and compelling findings of the interim analysis announced 4 May 2015.

REDUC Part B enrolled 20 patients. Data on viral load were obtained from 17 patients and 16 patients completed the trial.The headline results are: 1.The latent HIV reservoir was significantly reduced by 40% (Total HIV DNA and qVOA),2.Viral load remained below the level of detection in 11 out of 17 patients on combination antiretroviral therapy (cART) despite reservoir reactivation. Four patients had measureable but low viral load and only at one of the three romidepsin infusions. 3. The pharmacodynamic effect of romidepsin, i.e., reactivation of the latent HIV reservoir, was confirmed by increases in histone acetylation levels and viral expression. 4.The combination of Vacc-4x and romidepsin was safe and well tolerated.

The REDUC trial's objective was to address one of the core issues with clinical management of HIV infection, which is that some HIV infected cells remain hidden in latent reservoirs. The reservoirs are unaffected by conventional HIV medication and invisible to the immune system. Histone deacetylase inhibitors (HDACi) have the potential to activate (‘Shock’) these latently infected cells to produce virus. This ‘shock’ will make the HIV infected cells visible to the immune system; the immune responses generated by Vacc-4x will be able to attack and eliminate (‘Kill’) these infected cells.

Bionor is currently planning BIOSKILL a Phase II, randomized, double blind, placebo controlled clinical trial as the next step in developing a functional cure for HIV. The primary endpoint will be viral load during cART after each of three romidepsin infusions in Vacc-4x treated patients compared to placebo controlled patients. Secondary virological and immunological endpoints will include measurements of the size of the latent reservoir, CD4+ and CD8+ T cell counts, and other immunological parameters. The correlation between patients’ levels of anti-C5/gp41 antibodies and the ability to control virus in the blood will also be assessed. The BIOSKILL trial will not include cART treatment interruption.

The results create a strong foundation for further advancement of Vacc-4x as a core component in a functional cure for HIV. As previously communicated, Bionor expects to initiate the BIOSKILL clinical trial when funding has been secured to execute and complete the full scope of the trial. To date, Bionor has filed clinical trial applications for BIOSKILL in the United Kingdom, Germany, and Denmark.