The final assay in Bionor's REDUC trial for measuring latent HIV reservoir, Integrated HIV DNA, supports the Shock & Kill approach using Vacc-4x and romidepsin

BIONOR PHARMA ASA

STOCK EXCHANGE ANNOUNCEMENT

The final assay in Bionor's REDUC trial for measuring latent HIV reservoir, Integrated HIV DNA, supports the Shock & Kill approach using Vacc-4x and romidepsin

REDUC Part B results were presented today at the prestigious Conference on Retroviruses and Opportunistic Infections (CROI)

(Oslo, Norway, 23 February 2016) Bionor Pharma ASA (OSE:BIONOR), a biopharmaceutical company focused on advancing a functional cure for HIV, announces that the third and final assay for measuring latent HIV reservoir size, the primary endpoint in the REDUC Part B trial, supports that the combination of Vacc-4x and the latency reversing agent romidepsin (Istodax^®, Celgene) leads to a reduction in latent viral reservoir.

The REDUC Part B results were presented today at an oral presentation at the prestigious Conference on Retroviruses and Opportunistic Infections (CROI), in Boston, MA (USA). The presentation, entitled "Effect of Sequential Vacc-4x/GM-CSF Immunization and Romidepsin on the HIV Reservoir", which began at 10:15 am EST (16:15 CET), was delivered by Dr. Ole Schmeltz Søgaard from Aarhus University Hospital in Denmark.

In REDUC Part B, three different assays were selected to measure the effect on latent reservoir size due to ongoing discussions in the scientific HIV community on how best to estimate the true size of the reservoir and the effects of treatments. As reported on 21 December 2015, the first two assays demonstrated a significant reduction in the latent HIV reservoir (by 40% in Total HIV DNA and qVOA assays). 

Today Bionor reports results from the third assay of latent HIV reservoir by measuring levels of integrated HIV DNA. With the results of this assay showing a mean 13% non-statistically significant (p=0.271) reduction, the direction of all three assays is consistent. The technological differences between these assays in view of sample sizes allows no further comparison of absolute numbers.

Dr. David Horn Solomon, President and CEO commented:
"I am satisfied with the results announced today, which continue to validate that the combination of Vacc-4x and romidepsin is an important element in the development of a possible functional cure for HIV. The first announcement of final results from the REDUC trial in December 2015 fostered world-wide and substantial interest in Bionor from patients, opinion leaders and media, and with the findings presented today, we are further encouraged to continue our pioneering work. Also, I am proud that the REDUC results were accepted for oral presentation at CROI, which, in my view, supports that we have obtained important new scientific knowledge."