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Bionor Pharma – Update Clinical Development Program and Q4 2013 Results

(Oslo, Norway, 4 February 2014) Bionor Pharma ASA (OSE: BIONOR) announced today its fourth quarter and full year 2013 results.

Webcast The Q4 report will be presented by webcast 4 February at 8.30 am CET.
Link for registration and access to the webcast: http://www.media-server.com/m/p/25iha6h9

Download the Q4-report and Q4-presentation.

The Company announced today the identification of a potential biomarker for Vacc-4x reduction of viral load. Biomarkers identify patients that are more likely to respond to Vacc-4x. Findings are based on a retrospective, exploratory subset analysis of the large Vacc-4x Phase II study that completed in 2010. The potential biomarker is elevated antibodies against the peptide construct of Bionor Pharma’s second vaccine candidate Vacc-C5 or “anti-C5 antibodies”. Biomarkers are commonly used in other therapeutic areas like oncology to identify “responders” to treatment. Analysis showed that patients that had a level of anti-C5 antibodies above 4 µg/ml experienced a reduction of 0.94 log or 88% in viral load compared to their pre-cART viral load. In contrast patients with antibody levels below 4 µg/ml had a reduction in viral load of 0.20 log or 37% compared to their pre-cART viral load. This analysis indicates that anti-C5 antibodies may be used as a potential biomarker to predict improved response to Vacc-4x vaccination.

Bionor Pharma further announces today that the enrollment of the Part B of the Vacc-4x and lenalidomide Phase II trial (“Kill & Boost”) is completed and 24 patients are enrolled. Time from last patient first visit to readout of top line results is approximately eight months and results are expected in Q4 2014.

Through its development program Bionor Pharma search for a Functional Cure for HIV. This will enable people to live long-term with no disease progression or HIV transmission in the absence of conventional HIV medication. The combination strategy is called "Kick, Kill and Boost". 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 lenalidomide.

The application for the REDUC Vacc-4x/HDACi Phase I/II trial (Kill & Kick study) was submitted to the Danish Regulators & Ethical Committee in November. Only minor additions to the protocol remain before approval is expected in February. Enrollment of patients is expected to start in Q2 2014.

Last patient, last visit is completed for the Vacc-4x Reboost Phase II trial and for the Vacc-C5 Phase I/II trial and results are expected in Q1 2014.

“The execution of the Kick, Kill & Boost strategy is on track. We will see readout from our Phase II Reboost trial within the quarter, planning of the REDUC trial progresses well and enrollment of the lenalidomide trial is complete.” says CEO Dr. Anker Lundemose “In addition, we have announced today the identification of a potential biomarker that may predict how well patients respond to Vacc-4x. This can prove to be an important step for Bionor Pharma in our pursuit to find a functional cure for HIV patients.”

The Group reported a net loss of NOK 25.4  million in the fourth quarter (NOK 21.6 million) and a net loss of NOK 85.4 million (NOK 66.8 million) for the full year 2013. The cash flow from operations in the fourth quarter was negative NOK 17.2 million (negative NOK 17.7 million) and the net cash at period end was NOK 107.5 million (NOK 106 million).

Bionor Pharma ASA

CFO Synne H. Røine +47 99 22 98 92