BERGEN, Norway, Jan. 9 2019
/PRNewswire/ -- BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company focused on developing a pipeline of
first-in-class drug candidates targeting AXL kinase to treat
aggressive diseases including immune-evasive and therapy resistant
cancers, announces today that the first subject has been
dosed in a Phase I clinical trial evaluating the anti-AXL
therapeutic monoclonal antibody BGB149 in healthy
volunteers.
BGB149 is the first functional blocking anti-AXL monoclonal
antibody to enter clinical development and is BerGenBio's second
clinical stage drug development programme targeting AXL.
Richard Godfrey, Chief
Executive Officer of BerGenBio, commented: "We are delighted to
initiate this Phase I study as planned. BGB149 has cleared all
required regulatory pre-clinical evaluations. This AXL functional
blocking antibody is BerGenBio's second drug candidate to enter
clinical trials: An important milestone in expanding our pipeline
of first-in-class AXL targeting drug candidates positioned to treat
aggressive diseases with severe unmet medical need. We are
expecting results from this Phase I trial in 2019 and are looking
forward to announcing BGB149's further clinical development
strategy in the coming months."
About BGB149 and the Phase I Healthy Volunteer Trial
BGB149 is a fully humanised anti-AXL functional blocking
monoclonal antibody, developed and fully-owned by BerGenBio. A
robust, high yielding manufacturing process has been established
and preclinical studies have confirmed its mechanism of action as
well as efficacy.
The Phase I healthy volunteer trial BGB149-101 will enrol up
to 36 subjects andinvestigate the safety, tolerability and
pharmacokinetics of BGB149 following single dose administration.The
study is being sponsored by BerGenBio.
For more information, see
ClinicalTrials.gov: NCT03795142
About AXL
AXL kinase is a cell membrane receptor and an essential mediator
of the biological mechanisms underlying life-threatening diseases.
In cancer, AXL suppresses the body's immune response to tumours and
drives cancer treatment failure across many indications. AXL
inhibitors, therefore, have potential high value at the centre of
cancer combination therapy, addressing significant unmet medical
needs and multiple high-value market opportunities. Research has
also shown that Axl mediates other aggressive
diseases.
About BerGenBio ASA
BerGenBio is a clinical-stage biopharmaceutical company focused
on developing transformative drugs targeting AXL as a potential
cornerstone of therapy for aggressive diseases, including
immune-evasive, therapy resistant cancers. The company's
proprietary lead candidate, bemcentinib, is a potentially
first-in-class selective AXL inhibitor in a broad phase II oncology
clinical development programme focussed on combination
and single agent therapy in lung cancer and leukaemia. A
first-in-class functional blocking anti-AXL antibody is undergoing
Phase 1 clinical testing. In parallel, BerGenBio is developing a
companion diagnostic test to identify those patient populations
most likely to benefit from bemcentinib: this is expected to
facilitate more efficient registration trials supporting a
precision medicine-based commercialisation strategy.
BerGenBio is based in Bergen,
Norway with a subsidiary in Oxford, UK. The company is listed on the Oslo
Stock Exchange (ticker: BGBIO). www.bergenbio.com
Contacts
Richard Godfrey CEO
BerGenBio ASA
+47-917-86-304
Rune Skeie, CFO
BerGenBio ASA
rune.skeie@bergenbio.com
+47-917-86-513
International Media Relations
David Dible
Mark Swallow
Marine Perrier
Citigate Dewe Rogerson
bergenbio@citigatedewerogerson.com
+44-207-638-9571
Media Relations in Norway
Jan Petter Stiff
Crux Advisers
stiff@crux.no
+47-995-13-891
Forward looking statements
This announcement may contain forward-looking statements, which
as such are not historical facts, but are based upon various
assumptions, many of which are based, in turn, upon further
assumptions. These assumptions are inherently subject to
significant known and unknown risks, uncertainties and other
important factors. Such risks, uncertainties, contingencies and
other important factors could cause actual events to differ
materially from the expectations expressed or implied in this
announcement by such forward-looking statements.
This information is subject to the disclosure requirements
pursuant to section 5-12 of the Norwegian Securities Trading
Act.
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SOURCE BerGenBio ASA