(Oslo, Norway, 13 June 2016) Bionor Pharma ASA (Bionor) (OSE:BIONOR), today provides an update on scientific collaborations in relation to the company’s HIV immunotherapy pipeline. On 31 May 2016, the Board of Directors announced a clinical strategy with continued focus on HIV immunotherapy and functional cure, which are complex scientific areas, and best pursued through collaborative efforts.
Currently, Bionor’s scientific collaborations include possible extension of the ongoing collaboration with Celgene Corporation as well as finalization of research and scientific publication of the work conducted with St. Georges University of London, UK and SCHARP (Statistical Center for HIV/AIDS Research and Prevention) at the Fred Hutchinson Research Institute, USA.
Bionor and Celgene have had a fruitful collaboration since 2011, when the IMiD trial with Vacc-4x and lenalidomide (Revlimid®, supplied by Celgene Corporation) trial was initiated.
Unni Hjelmaas, acting CEO, said:“We believe that the combination of Vacc-4x and lenalidomide in the IMiD trial showed promising efficacy while exhibiting an acceptable safety profile. A review of preliminary long-term follow-up data from the trial has been initiated with the intention of identifying how the company can best leverage the encouraging results from the trial.”
The collaboration did continue with the successful REDUC trial, for which Celgene provided romidepsin (Istodax®), and expanded in July 2015, where Bionor and Celgene agreed, that Celgene would secure a continued supply of romidepsin for use in the planned BIOSKILL trial.
In addition, to achieve a functional cure for HIV, a combination of more than two agents will likely be required. Bionor is currently considering which additional immune regulating agents could be relevant, and owing to the encouraging results from the IMiD trial, lenalidomide is a natural part of these considerations.
St. Georges University of London (SGUL)
Bionor has had a longstanding collaboration with SGUL, and the projects have been partly financed by the Research Council of Norway GLOBVAC and BIA programs.
The current project addresses immune activation in HIV infection and the potential role of a specific region on the HIV envelope glycoprotein in this process. Bionor has developed a peptide antigen, Vacc-C5, corresponding to this region. Earlier work has shown that the presence of antibodies to the C5 region of HIV is associated with slowed disease progression. Bionor has extended this work by analyzing the prevalence of antibody responses to Vacc-C5 in HIV patient cohorts. The collaboration with SGUL is addressing the mechanisms by which this region of HIV-1 may contribute to immune activation, and how antibodies to this region may reduce these effects. The study has also carried out preclinical work addressing the potential to use Vacc-4x and Vacc-C5 together. A scientific publication of the results is expected later this year.
SCHARP, Fred Hutchinson Research Institute
Bionor has had a collaboration with SCHARP since 2014 with the purpose of performing a post-hoc statistical analysis of data from the large 2007 phase II clinical trial (CT BI-Vacc-4x 2007/1) where Vacc-4x showed a statistically significant reduction in viral load set point compared to placebo patients (Pollard et al., 2014)1.
It has been confirmed that Vacc-4x provided a positive effect on both CD4 counts and viral load compared to placebo. These results were published earlier this year in a peer-reviewed journal (Huang et al., 2016)2.
In the collaboration with SCHARP, Bionor is also seeking to identify candidate biomarkers and immune correlates of the effect of Vacc-4x. This work is expected to be published in a scientific journal later this year.
1) Pollard RB, Rockstroh JK, Pantaleo G, Asmuth DM, Peters B, Lazzarin A, Garcia F, Ellefsen K, Podzamczer D, van Lunzen J, Arastéh K, Schürmann D, Clotet B, Hardy WD, Mitsuyasu R, Moyle G, Plettenberg A, Fisher M, Fätkenheuer G, Fischl M, Taiwo B, Baksaas I, Jolliffe D, Persson S, Jelmert O, Hovden AO, Sommerfelt MA, Wendel-Hansen V, Sørensen B. (2014). ‘Safety and efficacy of the peptide-based therapeutic vaccine for HIV-1, Vacc-4x: a phase 2 randomised, double-blind, placebo-controlled trial’. Lancet Infectious Diseases 14:291-300
2) Huang Y, Zhang L, Jolliffe D, Hovden AO, Ökvist M, Pantaleo G, Sommerfelt MA (2016), ‘A Case for preART-Adjusted Endpoints in HIV Therapeutic Vaccine Trials’, Vaccine 34: 1282-1288).
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.