BERGEN, Norway, Nov. 13, 2018 /PRNewswire/ -- BerGenBio ASA (OSE:
BGBIO), a clinical-stage biopharmaceutical company developing
novel, selective AXL kinase inhibitors for multiple cancer
indications, announces its results for the third quarter 2018. A
presentation of the results by the Company's management will take
place today at 10.00 am CET in
Oslo – details below.
Richard Godfrey, Chief
Executive Officer of BerGenBio, commented: "We are
pleased with the progress of our phase II clinical development
programme with our selective AXL inhibitor bemcentinib,
particularly in NSCLC. The observed correlation between patient
response and positive AXL status in our combination trial with
KEYTRUDA gives us confidence in bemcentinib's proposed mode of
action and its broad appeal as a promising new agent treating
aggressive cancer. The next six to nine months will be an exciting
time for the company as we anticipate further clinical data from
our phase II trials, particularly in NSCLC and acute myeloid
leukaemia."
Highlights – Third Quarter & 2018
Bemcentinib/KEYTRUDA® combination in advanced non-small cell
lung cancer (NSCLC) delivers highly promising phase II clinical
results
- 40% overall response rate & 70% clinical benefit rate
observed in AXL-positive, previously treated NSCLC patients,
including PD-L1 negative patients (data presented at World
Conference on Lung Cancer (WCLC))
- 5.9 months median progression-free-survival (PFS) in AXL
positive vs. 3.3 months in AXL negative patients presented as late
breaking abstract at Society Immunotherapy of Cancer congress
(SITC, post-period)
- Efficacy endpoint met and stage two of the trial actively
enrolling
Additional lung cancer phase II trials show promise for
bemcentinib in combination with chemo- and targeted agents
- Median PFS of NSCLC patients receiving the bemcentinib/TARCEVA®
combination in first line has surpassed that of TARCEVA monotherapy
(data presented at WCLC)
- Encouraging efficacy reported for bemcentinib in combination
with docetaxel chemotherapy in patients who had exhausted all
available therapy options (data presented at WCLC)
Tissue- and blood-based biomarkers with potential for
development as companion diagnostics
- Novel biomarkers identified and qualified across multiple
clinical trials with bemcentinib, presented as poster discussion at
EuropeanSociety for Medical Oncology meeting (ESMO) and SITC 2018
(post period)
Arbitration process with Rigel Pharma Inc.
- The Company is seeking clarification of interpretation and
application of certain provisions of the 2011 bemcentinib license
agreement
Anticipated data and news flow in the coming
months
- AML and MDS mono- and combination therapy at ASH 2018
- Stage 2 of bemcentinib/KEYTRUDA combination trial in H1
2019
- IND filed for BGB149, first in class AXL function blocking
antibody (post period)
Financial Highlights
(Figures in brackets = same period 2017 unless otherwise
stated)
- Total operating expenses for the third quarter were
NOK 38.1 million (NOK 36.6 million). Total operating expenses for
the first nine months of 2018 amounted to NOK 143.6 million (NOK
136.2 million)
- Research and development expenses accounted for 75.3 % of total
operating expenses in Q3, and 72.3 % for the first nine months of
2018
- Comprehensive loss for the third quarter amounted to
NOK 37.7 million (loss of
NOK 35.4 million). Comprehensive loss
for the first nine months of 2018 was NOK
140.7 million (loss of NOK 134.6
million)
- Cash and cash equivalents amounted to NOK 398.2 million at the end of September 2018 (NOK 440.3
million at 30 June 2018 and
NOK 370.3 million at 31 December 2017)
Presentation and Webcast Details
A presentation by BerGenBio's senior management team will take
place at 10.00 am CET at:
Hotel Continental, Stortingsgaten 24/26, 0117 Oslo
The presentation will webcast live and the link will be
available at www.bergenbio.com in the section Investors/
Financial Reports. A recording will be available shortly after the
webcast has finished.
The results report and the presentation will be available
at www.bergenbio.com in the section: Investors/ Financial
Reports from 7:00 am CET the same
day.
About AXL
AXL kinase is a cell membrane receptor and an essential mediator
of the biological mechanisms that drive aggressive and
life-threatening diseases. In cancer, AXL drives tumour survival,
treatment resistance and spread, as well as suppressing the body's
immune response to tumours. AXL expression has been established as
a negative prognostic factor in many cancers. AXL inhibitors,
therefore, have potential value at the centre of cancer combination
therapy, addressing significant unmet medical needs and multiple
high-value market opportunities.
About BerGenBio ASA
BerGenBio is a clinical-stage biopharmaceutical company focused
on developing transformative drugs targeting AXL as a potential
cornerstone of therapy for advanced and aggressive cancers. The
company's proprietary lead candidate, bemcentinib, is a potentially
first-in- class selective AXL inhibitor in a broad phase II
clinical development programme. Ongoing clinical trials are
investigating bemcentinib in multiple solid and haematological
tumours, in combination with current and emerging therapies
(including immunotherapies, targeted therapies and chemotherapy),
and as a single agent.
In parallel, BerGenBio is developing a companion diagnostics
test to identify patient populations most likely to benefit from
bemcentinib: this is expected to facilitate more efficient
registration trials and support 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
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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BGBIO 2018
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BGBIO 2018
3Q-presentation
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SOURCE BerGenBio ASA