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.”
The completion of the REDUC trial constitutes 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 international and controlled BIOSKILL clinical trial when funding has been secured to execute and complete the full scope of the trial. To date, Bionor has received approval of its clinical trial applications for BIOSKILL in the United Kingdom and Denmark.
Please refer to the stock exchange announcement from 21 December 2015 for further information about the REDUC trial and Bionor’s development plans.
This information is subject of the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.
David Horn Solomon, President and CEO, +45 22 20 63 00, email@example.com
Jørgen Fischer Ravn, VP Investor Relations & Communications, +45 20 30 39 03, firstname.lastname@example.org
Bionor Pharma is a Norwegian biopharmaceutical company focused on advancing its proprietary therapeutic vaccine Vacc-4x in combination with other medicines toward a functional HIV cure. The company believes it has first mover potential based on clinical results to date and early adoption of now recognized clinical strategy. In December 2015, Bionor announced that the HIV ’Shock & Kill’ trial REDUC with Vacc-4x and romidepsin successfully met its primary endpoint by reducing latent HIV reservoir and further demonstrated control of viral load. Bionor is currently planning BIOSKILL, a proof-of-concept Phase II trial, which may lead to a major value inflection point and partnering opportunities. Bionor currently retains full ownership rights to Vacc-4x, i.e., the upside potential from partnering or licensing remains with the company. Bionor is based in Oslo, Norway, and also has offices in Copenhagen, Denmark and New York, USA. Bionor is listed on Oslo Børs (OSE:BIONOR). More information about Bionor is available at www.bionorpharma.com.
Announcement as PDF