Regulatory Filings • Nov 2, 2018
Regulatory Filings
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BerGenBio to present late-breaking abstract on Phase II trial of bemcentinib in combination with KEYTRUDA® in advanced NSCLC at SITC
· Combination of selective AXL inhibitor bemcentinib and KEYTRUDA® featured in
late breaking abstract at leading IO conference SITC
· Analysis comprises stage 1 (n=24) in PhII trial in 2L advanced NSCLC
· Stage 2 open and enrolling
Bergen, Norway, 2 November 2018 - BerGenBio ASA (OSE:BGBIO) announces that the
analysis of the first stage of its Phase II clinical trial with bemcentinib, a
first-in-class selective oral AXL inhibitor, in combination with the anti-PD-1
therapy KEYTRUDA® (pembrolizumab) in patients with previously treated, advanced
non-small cell lung cancer (NSCLC) has been selected as a Late-breaking Abstract
at the annual Society for Immunotherapy in Cancer (SITC) 2018 congress in
Washington D.C. (7-10 November 2018).
Late-breaking abstracts highlight novel and potentially practice-changing
studies, and their acceptance for presentation is subject to favourable
assessment by a panel of clinical and scientific experts. In total, only 21
abstracts were accepted in the late-breaking category at this year's SITC
congress: https://sitc.sitcancer.org/2018/abstracts/titles/late-breaking/
An update from BerGenBio's biomarker and companion diagnostic programme will
also be presented as a poster within the regular abstract section. See details
below.
Presentations at SITC: Friday 9 November, 12:45 - 2:15 p.m. and 6:30 - 8
p.m. EST, Hall E
A Phase II study of bemcentinib (BGB324), a first-in-class selective AXL
inhibitor, in combination with pembrolizumab in patients with advanced
NSCLC: Analysis of the first stage
· Matthew Krebs, PhD et al
· Category: 33rd Annual Meeting Late-Breaking Abstracts
· Presentation number: P715
Predictive and pharmacodynamic biomarkers associated with treatment with
the oral selective AXL Inhibitor bemcentinib in combination with
pembrolizumab in patients with advanced NSCLC and Melanoma
· Robert Holt, PhD, et al
· Category: Biomarkers and Immune Monitoring
· Presentation number: P115
The full abstracts will be published on November 6th at 8 a.m. Eastern time at
https://www.sitcancer.org/2018/home.
- END -
About SITC
The Society for Immunotherapy of Cancer (SITC) is the world's leading member
-driven organisation specifically dedicated to improving cancer patient outcomes
by advancing the science and application of cancer immunotherapy. Over 4,000
delegates are expected to attend the SITC 33rd Annual Congress in Washington
D.C. on Nov 7-10 2018. For more information please see www.sitcancer.org
About the BGBC008 trial: A Phase II study of bemcentinib in combination with
pembrolizumab in patients with previously treated advanced NSCLC
The BGBC008 trial is a phase II multi-centre open-label study of bemcentinib in
combination with KEYTRUDA (pembrolizumab) in previously treated, immunotherapy
naïve, patients with advanced adenocarcinoma of the lung, the most common form
of non-small cell lung cancer (NSCLC). The objective of the trial is to
determine the anti-tumour activity of this novel drug combination. Responses
will be correlated with biomarker status (including AXL kinase and PD-L1
expression).
For more information please access trial NCT03184571 at www.clinicaltrials.gov.
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
Contacts
Richard Godfrey
CEO, BerGenBio ASA
+47 917 86 304
Rune Skeie, CFO, BerGenBio ASA
+47 917 86 513
International Media Relations
David Dible, Mark Swallow, Marine Perrier, Citigate Dewe Rogerson
+44 207 638 9571
Media Relations in Norway
Jan Petter Stiff, Crux Advisers
+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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