Bionor provides an update on scientific collaborations
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BIONOR PHARMA ASA
STOCK EXCHANGE ANNOUNCEMENT
Bionor provides an update on scientific collaborations
(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.
Celgene Corporation
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).
Further information
Unni Hjelmaas, Acting CEO, +47 915 19 651, uh(at)bionorpharma.com
Jørgen Fischer Ravn, VP Investor Relations & Communications, +45 2030 3903,
jfr(at)bionorpharma.com
About Bionor
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.
Update on scientific collaborations:
http://hugin.info/131219/R/2020143/750251.pdf
This announcement is distributed by GlobeNewswire on behalf of
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(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Bionor Pharma ASA via GlobeNewswire
[HUG#2020143]
Unternehmensinformation / Kurzprofil:
Datum: 13.06.2016 - 16:08 Uhr
Sprache: Deutsch
News-ID 477347
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contact information:
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