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New Clinical Strategy Towards a Potential “Functional Cure” for HIV Announced at Today’s Capital Markets Day

Bionor Pharma Plans for a First-Mover Clinical Study Combining its Therapeutic HIV Vaccine Vacc-4x with an HDAC Inhibitor

(Oslo, Norway, 14 June 2013)  Bionor Pharma ASA (OSE: BIONOR) meets today with investors and analysts at its Capital Markets Day to present the Company’s new clinical strategy in its pursuit of a Functional Cure for HIV.  As one of the key elements of the new strategy, Bionor Pharma plans to initiate a study combining its therapeutic T-cell vaccine Vacc-4x with an HDAC inhibitor (HDACi).

Link to the presentation, click here

“One of the core issues with the treatment of HIV is that some HIV infected cells hide in so-called latent reservoirs where they remain unaffected by conventional HIV medication and invisible to the immune system”, said CEO Anker Lundemose MD PhD. “HDAC inhibitors have the potential to activate these latently infected cells. This will make the HIV infected cells visible to the immune system, which can be educated by Vacc-4x to eliminate the infected cells and thereby reduce the reservoirs, which would be a significant step towards a Functional Cure for HIV”.

“As an additional piece of the puzzle towards a Functional Cure, an immunomodulator such as lenalidomide might boost efficacy even further,”said Dr. Lundemose. “Bionor Pharma has the furthest advanced T-cell vaccine in the HIV space and I am incredibly excited about this opportunity for our shareholders and patients of the “First Mover” advantage we have in this field.”

The new combination strategy is called “Kick” (HDACi reactivation of virus), “Kill” (Vacc-4x’s training of the cellular immune system leading to killing of virus infected cells) and “Boost” (lenalidomide immune stimulation). Following data/results from the ongoing lenalidomide, reboost and Vacc-C5 studies, the ultimate and optimal combination studies will be performed with the aim of advancing the goal of finding Functional Cure for HIV.

Vacc-4x has previously demonstrated a 64 % viral load reduction in a randomized Phase II multinational study.  Vacc-4x is currently in a clinical study investigating  “reboosting” of patients from the multinational study to see if viral load can be reduced further.  An additional, ongoing study is exploring the use of Vacc-4x in combination with the immunomodulator Revlimid® (lenalidomide). The Company’s second therapeutic vaccine candidate, Vacc-C5 is in a phase I/II study aimed at generating antibody against the C5 region of the HIV virus.

At today’s Capital Markets Day, the management of Bionor Pharma will give a detailed overview and update on current and future clinical activities including the new HDACi & Vacc-4x initiative.

The Management of Bionor Pharma is of the firm belief that the First Mover potential of this new strategy and the optimal combination options will drive value creation, partnering and exit optionality going forward.

Initiation of the first part of the new strategy, the HDACi & Vacc-4x combination clinical study, can be executed without awaiting data from ongoing studies as Vacc-4x already has demonstrated a significant effect on reducing viral load in HIV patients. However, Bionor shall over the coming months continue its detailed planning of the new development initiative including determination of the precise costs, timelines, milestones and deliverable as well as obtaining regulatory feedback.

For executing Bionor’s new HDACi & Vacc-4x combination strategy, the Company will evaluate all options including various strategic and financial opportunities. Bionor Pharma will keep the market appraised of any updates and progress over the coming months and will announce the outcome of this process by H2 2013.

Professor Lars Østergaard, one of the world’s leading experts in the exploration of HDACi in HIV patients will speak at today’s event, in addition to Professor Angus Dalgleish from St. George’s University of London.

Today’s Capital Markets Day, to be held at Hotel Continental in Oslo at 10 am CET, will be recorded and made available at the Company’s website following the event.

Bionor Pharma ASA

Anker Lundemose
CEO
Tel +47 23 01 09 60

Synne H Røine
CFO
Tel + 47 99 22 98 92

Hilde Aalling Syvertsen,
-Director Communications & Corporate Affairs 
Tel +47 23 01 09 60

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

This information is subject to the disclosure requirements of §5-12 vphl(Norwegian Securities Trading Act). 

Vacc-4x, Vacc-C5, are currently investigational treatments that have not been approved for marketing by any regulatory authority.