Bionor enters into romidepsin supply agreement enabling advancement of its HIV therapeutic vaccine with Vacc-4x into full scale clinical Phase II
(Oslo, Norway, 16 July 2015) Bionor Pharma ASA (Bionor) (OSE:BIONOR), a peptide vaccine company advancing a potential first therapeutic vaccine towards a functional cure for HIV, has signed an agreement with Celgene Corporation (Celgene) securing a continued supply of romidepsin (Istodax®) for use in a planned multicenter clinical Phase II study of Bionor’s most advanced and proprietary vaccine, Vacc-4x, with romidepsin.
The planned study will continue to explore the “Kick and Kill” strategy of Bionor’s ongoing REDUC study, for which Celgene
also supplies romidepsin. In Part A of the REDUC study, completed in 2014, it was demonstrated that romidepsin was safe, well
tolerated and able to release HIV viral DNA from latent reservoirs into the blood stream in HIV infected patients on anti-retroviral
treatment. An interim analysis of Part B of the REDUC study announced on 4 May 2015 indicated killing of reactivated HIV and
reduction in latent viral reservoir when patients received Vacc-4x prior to romidepsin.
David H. Solomon, President and CEO comments:
“This agreement with Celgene is very important for us. In our view, it’s a recognition of Bionor’s therapeutic vaccine approach to a functional cure for HIV and consistent with our reinvigorated strategic intent to focus on further advancement of Vacc-4x in combination with a latency reversing agent. Bionor is the only company which has an HIV vaccine together with a latency reversing agent in humans in clinical trials, and we have intriguing and promising results from the REDUC study showing that romidepsin worked to kick the latent virus out of the reservoirs, and that the addition of Vacc-4x indicated killing of reactivated HIV. With the new supply agreement we have taken a great step forward in our preparation of the next full scale Phase II study with the aim to obtain significant proof, that a Kick and Kill strategy combining Vacc-4x with an HDAC inhibitor is the likely path to a functional cure for HIV.”
As announced on 5 May 2015, Bionor is currently preparing a proof of concept clinical Phase II study of Vacc-4x together with romidepsin with the aim of investigating the contribution of Vacc-4x as a component in a functional cure for HIV. Planning of the contemplated clinical trial is ongoing, but no final decisions have yet been taken with respect to design, timing or size of the clinical trial.
This information is subject of the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.
David H. Solomon, President and CEO
M: +45 22 20 63 00
Jørgen F. Ravn, VP Investor Relations & Communications
M: +45 20 30 39 03
Bionor Pharma ASA is a leading biotechnology company advancing a potential first therapeutic vaccine towards a functional cure for HIV. The company's focus is the research and development of peptide-based vaccines against viral diseases, primarily HIV. Bionor’s most advanced product candidate is Vacc-4x, which is also the most advanced therapeutic vaccine in the HIV space and 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, with offices in Copenhagen and New York, and is listed on the Oslo stock exchange, under the ticker BIONOR. More information about Bionor is available at www.bionorpharma.com.