Regulatory Filings • Oct 9, 2018
Regulatory Filings
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BerGenBio to present interim phase II clinical, preclinical and biomarker data with selective AXL inhibitor bemcentinib at ESMO
Bergen, Norway, 9 October 2018 - BerGenBio ASA (OSE:BGBIO) announces that the
company and its collaborators will present interim clinical and biomarker data
from its Phase II clinical programme with bemcentinib (BGB324), a first-in-class
highly selective oral AXL inhibitor at the ESMO 2018 Congress in Munich (19 - 23
October 2018).
Pre-clinical data on the role of AXL inhibition in Myelodysplastic Syndrome
(MDS) will also be presented. Details of the presentations are below.
The posters will be made available at www.bergenbio.com in the Investors /
Presentations section at the time of presentation and full abstracts will be
made available online according to ESMO's embargo schedule:
https://www.esmo.org/Conferences/ESMO-2018-Congress/Abstracts
Poster presentations at ESMO:
Sunday 21 October, 11:15 - 12:15, Hall B3 - Room 21
Predictive and Pharmacodynamic Biomarkers Associated with Phase II, selective
and orally bioavailable AXL Inhibitor Bemcentinib Across Multiple Clinical
Trials
· Robert Holt, PhD et al
· Poster Discussion session - Translational research 2
· Invited discussant: 11:15 - 11:45
· Presentation number: 63PD
Sunday 21 October, 12:45 - 13:45, Hall A3 - Poster Area
Update on the randomised Phase Ib/II study of the selective small molecule AXL
inhibitor bemcentinib (BGB324) in combination with either dabrafenib/trametinib
or pembrolizumab in patients with metastatic melanoma
· Cornelia Schuster, MD, PhD et al
· Poster display session - Melanoma and other skin tumours
· Presentation number: 1266P
Sunday 21 October, 16:30 - 17:45, Hall B3 - Room 21
The identification of the AXL/Gas6 signalling axis as a key player of
myelodysplastic syndrome (MDS) and the potential of the oral selective AXL
inhibitor bemcentinib in the treatment of MDS
· Hind Medyouf, PhD et al
· Poster Discussion session - Haematological malignancies
· Invited discussant: 16:30 - 16:55
· Presentation number: 1009PD
- END -
About the ESMO Congress
The ESMO Congress is the leading European meeting for medical oncology convening
over 20,000 international delegates from the field. ESMO 2018 will be held in
Munich, Germany 19- 23 October 2018.
About BerGenBio's Companion Diagnostics programme
In parallel with its phase II clinical trial programme, BerGenBio explores
predictive biomarker candidates with the aim to develop a companion diagnostic
to identify patients most likely to benefit from bemcentinib treatment.
Thus far, the company reported strong correlation with response of both plasma
soluble AXL levels and the presence of tissue AXL in relapsed/refractory AML or
MDS and advanced NSCLC, respectively.
About the BGBIL006 trial
Melanoma is the most serious type of skin cancer as it may spread to lymph nodes
and distant organs if not discovered in time. Melanoma occurs when the cells
that colour the skin, the so-called melanocytes, start to divide uncontrollably.
The BGBIL006 trial is a randomised Phase 1b/2 investigator sponsored clinical
study of bemcentinib (BGB324) in combination with either the MAPK inhibitors
MEKINIST® (trametinib) plus TAFINLAR® (dabrafenib) or the immune checkpoint
inhibitor KEYTRUDA® (pembrolizumab) in patients with advanced melanoma.
For more information please access trial NCT02872259at www.clinicaltrials.gov.
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
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.
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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