(Oslo, Norway, 9 June 2016) Bionor Pharma ASA (Bionor) (OSE:BIONOR), announced today that the positive results from the clinical trial REDUC Part B (BPC01-001) will be published for the first time in the peer-reviewed and highly recognized journalThe Lancet HIV.
The manuscript, entitled “The combined effect of Vacc-4x/rhuGM-CSF vaccination and romidepsin on the HIV-1 reservoir: a phase Ib/IIa, single group, clinical trial”, will be published online shortly. Ole Schmeltz Søgaard from Aarhus University Hospital in Denmark is corresponding author of the manuscript. Top line results from REDUC Part B were announced by Bionor on 21 December 2015.
The REDUC Part B trial resulted in important signals, which provide the first evidence for the feasibility of a Shock & Kill strategy for achieving a functional cure for HIV infection:
- Latent HIV reservoir was significantly reduced by approximately 40% measured by Total HIV DNA and qVOA. Measured by Integrated HIV DNA, a statistical non-significant decrease of 19% was observed.
- Viral load (Plasma HIV-1 RNA) remained below the limit of detection (20 copies/ml) in 11 of 17 patients throughout the trial while on cART despite a documented viral reactivation in CD4+ T cells following romidepsin infusions. Of the six patients with detectable viral load, four patients had measureable but low HIV in the blood after one of the three romidepsin infusions. Importantly, only two of 17 patients had detectable viral load after each of the three romidepsin infusions.
- The treatment of Vacc-4x/rhuGM-CSF and romidepsin (Istodax®, supplied by Celgene Corporation) was safe and well tolerated. All adverse reactions were consistent with the known side effects of either romidepsin or Vacc-4x/rhuGM-CSF.
These results are crucial in showing that Vacc-4x administered with rhuGM-CSF is capable of priming the immune system to control HIV in the blood after the virus has been ‘shocked’ out of its dormant state by a latency reversing agent. The trial results are supported by previous data, demonstrating that Vacc-4x/rhuGM-CSF reduced the viral load set-point during antiretroviral treatment interruption in a placebo-controlled trial (CT BI-Vacc-4x 2007/1).
Unni Hjelmaas, Acting CEO, commented: “The publication of the REDUC Part B results in The Lancet HIV underpins our view that Bionor is advancing a first-in-class functional cure for HIV. Having peer reviewers support that trial results are very encouraging and provide the first evidence that the concept of Shock & Kill may work is reassuring for our ongoing efforts to secure the future financing of the company and position our therapeutic vaccine Vacc-4x as a core component in HIV immunotherapy.”
The results also emphasize that further optimization of the Shock & Kill strategy is needed to achieve a sizeable impact on the latent reservoir that will translate into clinically measureable benefits for persons living with HIV, as the combined intervention did not prolong median time to viral rebound during ART interruption. Bionor anticipates that a third agent capable of further strengthening immune reactivity is needed as part of a combination treatment in addition to Vacc-4x and a latency reversing agent. These considerations have previously been described in the company’s announced clinical strategy and are being addressed in the BIONAB clinical trial.
Based on the REDUC data, Bionor is currently also planning BIOSKILL, a multicenter placebo-controlled proof of concept Phase II clinical trial, which is intended to document the potential of Vacc-4x as a core component of a HIV cure strategy.
Bionor Pharma is a Norwegian biopharmaceutical company focused on advancing its proprietary therapeutic vaccine Vacc-4x in combination with other medicines toward a functional HIV cure. The company believes it has first mover potential based on clinical results to date and early adoption of now recognized clinical strategy. In December 2015, Bionor announced that the HIV ’Shock & Kill’ trial REDUC with Vacc-4x and romidepsin successfully met its primary endpoint by significantly reducing latent HIV reservoir and further demonstrated control of viral load. Bionor is currently planning BIOSKILL, a proof-of-concept Phase II trial, which may lead to a major value inflection point and partnering opportunities. Bionor currently retains full ownership rights to Vacc-4x, i.e., the upside potential from partnering or licensing remains with the company. Bionor is based in Oslo, Norway and is listed on Oslo Børs (OSE:BIONOR). More information about Bionor is available at www.bionorpharma.com.