Bionor Pharma - Second quarter results 2014
(Oslo, 15.08.2014) Bionor Pharma ASA (OSE: BIONOR) announced today its financial results for the second quarter and first half of 2014 and update on its clinical development program.
- Bionor Pharma’s clinical results presented at AIDS 2014 IAS Conference
- REDUC trial part A demonstrated that romidepsin successfully reactivated HIV latent reservoirs – one of the key presentations at the conference
- Identification of C5 antibodies as potential biomarker for improved effect of Vacc-4x vaccination
- Further analysis of Vacc-4x Reboost Phase II study results demonstrate that Vacc-4x vaccination reduces proviral HIV DNA - measure of HIV reservoir
- Initial valuable discussions with FDA and EMA ongoing for Vacc-4x in subset of HIV patients
During the second quarter of 2014, the results from Part A of the REDUC trial were announced and later presented at the 20th International AIDS conference in Melbourne, Australia. The finding of C5 antibodies as a potential biomarker for improved response to Vacc-4x vaccination was also presented as a poster presentation at the conference. Part A of the REDUC trial demonstrated that the cancer drug, the HDAC inhibitor romidepsin was able to reactivate or “kick” the so-called latent virus reservoirs in HIV patients while on conventional HIV medication, cART (combination antiretroviral therapy). The results were well received by key opinion leaders and the research community. Professor Steven Deeks, UCSF, commented that the results from the REDUC trial were “the single most important advance of this meeting and that it will have a major impact on the future”.
The objective of the ongoing part B of the REDUC trial is to investigate whether vaccination of Vacc-4x followed by romidepsin treatment impacts the latent HIV reservoir and viral control. Romidepsin “kicks” the virus out of reservoirs making the HIV infected cells visible to the immune system. The immune response generated by Vacc-4x will then be able to attack and “kill” the infected cells leading to a potential reduction in of the latent reservoirs and viral load. The reduction of reservoirs and the reduction in viral load following a monitored cART treatment pause are the key outcomes of the REDUC part B study. The result of effect on the size of the HIV reservoir is expected H1 2015 and viral load results are expected in H2 2015.
Analysis of secondary endpoints and post-hoc analysis of Vacc-4x Reboost Phase II study have been finalized. The analysis showed that Vacc-4x vaccination significantly reduced proviral DNA with 47 percent. Proviral DNA is a measure of latent HIV reservoir. The results are promising for the ongoing REDUC trial where the effect of the latent reservoirs is one of the main objectives of the trial. Few study subjects were able to contribute data to the analysis of the impact of C5 antibodies and the results from the 2010 trial could not be reconfirmed in the Reboost study.
Bionor Pharma has met with FDA and EMA to discuss monotherapy options for Vacc-4x in subset of HIV patients. In a post-hoc exploratory analysis, Vacc-4x has shown an improved effect in “responders” (patients with high C5 antibodies) compared to the general population (reduction in viral load compared to preART levels of 88 percent versus 60 percent in all patients). The discussions with the agencies were fruitful and provided valuable input to the design of proof of concept studies in responders. Regulators advised that Vacc-4x as an add-on to cART in a subset of HIV patients characterized by elevated C5 antibodies may be a potential way forward towards regulatory approval. This is subject to confirmation of the post-hoc exploratory analysis and that clinical relevant outcomes have to be demonstrated in a relevant target population. Bionor Pharma will continue this dialogue with EMA and FDA and will also initiate discussions for path to market for “kick, kill & boost” strategy upon read out of the lenalidomide and REDUC part B studies.
The REDUC part A results and their reception at AIDS 2014 conference reconfirm Bionor Pharma’s development strategy “Kick, Kill & Boost”. The strategy explores Vacc-4x in combination with other medications in search for a Functional Cure for HIV. Furthermore the Company will continue the dialogue with regulators for the exploration of Vacc-4x monotherapy in “responders” as an add-on to cART in a subset of HIV patients as a potential path forward towards regulatory approval. “The results from the REDUC trial Part A and the recognition of its importance at the AIDS 2014 conference is a milestone for Bionor Pharma.” says CEO Dr. Anker Lundemose “It underscores our Kick and Kill strategy and the importance of being the first mover in the execution of this functional cure strategy.”
The Group reported a net loss of NOK 17 million in the second quarter (NOK 21.3 million). The cash flow from operations in the first quarter was negative NOK 21 million (negative NOK 14.3 million) and the net cash at period end was NOK 68.1 million (NOK 74.8 million).
Bionor Pharma ASA
CFO Synne H. Røine +47 99 22 98 92