Regulatory Filings • Oct 22, 2018
Regulatory Filings
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BerGenBio announces interim biomarker and phase II clinical data with selective AXL inhibitor bemcentinib presented at ESMO
Biomarker predicts clinical benefit rate of 70% and overall response rate of 40%
in second line NSCLC.
Melanoma combination study reports safety and efficacy.
Bergen, Norway, 22 October 2018 - BerGenBio ASA (OSE:BGBIO) announces that the
company and its collaborators have presented interim clinical and biomarker data
from BerGenBio's 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). Additionally, a pre-clinical study in
myelodysplastic syndrome (MDS) was presented.
The posters are available at www.bergenbio.com in the Investors / Presentations
section and a summary of results is given below.
(1) Poster Discussion: Predictive and Pharmacodynamic Biomarkers Associated
with Phase II, selective and orally bioavailable AXL Inhibitor Bemcentinib
Across Multiple Clinical Trials, Robert Holt et al
The poster discussed the broad biomarker programme run in parallel to the Phase
II clinical trial programme with bemcentinib and detailed some of the key
findings to date:
· Tumour AXL expression predicts patient benefit: 7 out of 10 second line
NSCLC patients showed clinical benefit (70% CBR) including 4 responses (40% ORR)
on KEYTRUDA/bemcentinib combination therapy (determined by BerGenBio's
proprietary immunohistochemistry method).
· Blood based biomarkers, including soluble AXL, have been found predictive of
patient benefit in relapsed/refractory AML/MDS & NSCLC.
(2) Poster Presentation: 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 et al
The poster gave an update on the randomised trial in first line metastatic
melanoma, combining bemcentinib with standard of care therapies:
· Confirmed recommended Phase II dose of bemcentinib in combination with
MEKINIST/TAFINLAR and KEYTRUDA.
· All combinations continue to be well tolerated.
· Efficacy is seen across all arms with 18 out of 23 radiographically
evaluated patients reporting clinical benefit including complete responses.
(3) Poster Discussion: 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 et al
The poster discussed the relationship between AXL and myelodysplastic syndrome
using both patient samples and animal model studies. The data show that AXL is
upregulated in MDS patients and that inhibiting AXL with bemcentinib shows
efficacy in pre-clinical models of the disease.
Richard Godfrey, CEO of BerGenBio, commented: The ability to predict which
patients are most likely to derive benefit from treatment is an important
competitive advantage as it is key to improving patient outcomes and regulatory
success. The data presented at ESMO increases our confidence in the predictive
nature of our proprietary biomarkers and diagnostics. What is more, 7 out of 10
AXL positive NSCLC patients showed clinical benefit in our phase II trial
combining bemcentinib with KEYTRUDA, this is a remarkable observation and gives
us confidence in bemcentinib's proposed mechanism of action. Additionally, data
presented at ESMO continue to show that bemcentinib is well tolerated and
effective across our broad Phase II combination programme. We are looking
forward to provide further updates on the development of our AXL inhibitor
pipeline over the coming months.
- END -
About the ESMO Congress
The ESMO Congress is the leading European meeting for medical oncology convening
over 26,000 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 BGBC008 trial
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 and 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 the BGBIL006 trial
The BGBIL006 trial is a randomised Phase 1b/2 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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