(Oslo, 14.05.2014) Bionor Pharma ASA (OSE: BIONOR) announced today its first quarter 2014 results.

Webcast The Q1 report will be presented by webcast 14 May at 8.30 am CEST.

Link for registration and access to the webcast: http://www.media-server.com/m/p/m9qvw3wq

Download the Q1-report and Q1-presentation. 

The results from the clinical trials and the identification of a potential biomarker in the first quarter 2014 have shaped the way forward for the development of Vacc-4x and Vacc-C5. 

Results from part A of the REDUC trial was announced earlier this week. Part A demonstrated that the dose of 5 mg/m2 of the HDAC inhibitor (HDACi) romidepsin was able to reactivate or "kick" the so-called latent virus reservoirs in HIV patients while still on conventional HIV medication, cART. Only minor adverse events were observed. Part B of the REDUC study will investigate the ability of Vacc-4x to eliminate or "kill" infected HIV cells following romidepsin reactivation of the latent HIV reservoir and reducing the reservoir. Agreement for free supply of romidepsin was entered into with Celgene in the quarter. Enrollment of patients for part B is expected to start in Q2 2014. Results regarding the effect on the size of the HIV reservoir may be available in H1 2015 whereas results from the overall study are expected in H2 2015.

Bionor Pharma has been granted GLOBVAC funding for the REDUC study and it is the third time the Company is granted funding from GLOBVAC. The grant is for up to NOK 16.8 mill over a three year period, exact size of grant is subject to final discussions with GLOBVAC.

The results from the Vacc-4x Reboost Phase II study were announced in the quarter. The results confirmed Vacc-4x' ability to reduce viral load, but the effects of reboosting was not statistically significant. Several patients did however experience a further reduction in viral load.

The retrospective, exploratory subset analysis of the large Vacc-4x Phase II 2010 study identified elevated C5 antibodies as possible biomarker to identify patients that are more likely to have an improved response to Vacc-4x ("responders"). Patients with elevated antibodies experienced a reduction in viral load after Vacc-4x vaccination of 88 % or log 0.94 compared to viral load before commencing cART whereas reduction in viral load for all patients was log 0.4 or 60% (p=0.0001). It is estimated that approximately 20-30 % of HIV patients have elevated C5 antibodies.

In February the Phase I/II Vacc-C5 results were announced. The results showed that the vaccine was well tolerated and was able to increase C5 antibodies levels in HIV patients with low pre-existing C5 antibodies. Bionor Pharma plans to develop Vacc-C5 in combination with Vacc-4x, Vacc-HIV, to enhance the effects of Vacc-4x vaccination.

The results from the Vacc-4x 2010 trial have been published in The Lancet Infectious Diseases (2014; 14: 291-300). The journal also published an editorial of the role of therapeutic vaccines in the treatment on HIV.

This quarter's data analyses and results reconfirm Bionor Pharma's overall development strategy for its HIV vaccines. The development strategy for Vacc-4x is centered on the exploration of monotherapy in a subset of HIV patients characterized by elevated C5 antibodies (biomarker), as well as the "Kick, Kill and Boost" strategy exploring Vacc-4x in combination with other medications in the search for a Functional Cure for HIV. The "Kick" refers to HDACi reactivation of virus. The "Kill" is Vacc-4x' training of the cellular immune system leading to killing of virus infected cells. The "Boost" is the stimulation of the immune system by IMiD (lenalidomide).

"It has been one of the most eventful quarters in Bionor Pharma's history. The results from the trials and analysis have brought the development of Vacc-4x forward." says CEO Dr. Anker Lundemose "The identification of a potential biomarker for Vacc-4x and the promising results from part A of the REDUC trial reconfirms our development strategy to enhance the effects of Vacc-4x and are key in our pursuit to find a functional cure for HIV patients."

The Group reported a net loss of NOK 21.6 million in the first quarter (NOK 18.3 million). The cash flow from operations in the first quarter was negative NOK 18.4 million (negative NOK 16.8 million) and the net cash at period end was NOK 89.1 million (NOK 89.2 million).

Bionor Pharma ASA
CFO Synne H. Røine +47 99 22 98 92

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