Regulatory Filings • Nov 11, 2020
Regulatory Filings
Open in ViewerOpens in native device viewer
BERGENBIO PRESENTS PHASE II BEMCENTINIB COMBINATION STUDY IN NSCLC AT ANNUAL SITC MEETING
Bergen, Norway, 11 November 2020 - BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical need, will today present an updated clinical &
translational analysis from its Phase II bemcentinib and pembrolizumab
combination study (BGBC008) in advanced non-small cell lung cancer (NSCLC), at
an oral presentation at the Society for Immunotherapy of Cancer (SITC) 35[th]
Annual Meeting.
The presentation will provide updated data from Cohort B of the study, assessing
the safety and efficacy of bemcentinib in combination with anti-PD-1 therapy
pembrolizumab, in 16 refractory NSCLC patients previously treated with a PD-L1
or PD-1 checkpoint inhibitor (CPI) as a monotherapy.
"AXL is implicated in resistance to immunotherapy and this study is based around
the hypothesis that blocking AXL signalling represents a novel approach to
prevent cancer survival mechanisms and to improve the efficacy of immuno
-oncology drugs," commented Professor James Spicer, PhD, who will give the
presentation at SITC. "Our findings from this interim analysis suggest that
bemcentinib has potential to reverse acquired resistance to checkpoint
inhibitors among previously treated NSCLC patients by targeting AXL expressing
macrophages and regulatory dendritic cells. These encouraging results support
the further development of AXL inhibition as a means to extend the efficacy of
immunotherapy in biomarker-selected NSCLC patients."
The combination of bemcentinib and pembrolizumab was overall shown to be well
tolerated and clinically active in CPI-refractory composite AXL (cAXL) positive
NSCLC. Of the evaluable patients in Cohort B 58% were cAXL-positive, 25% were PD
-L1 negative (<1%TPS), and 42% patients were PD-L1 low positive (1-49% TPS). 86%
of cAXL-positive patients achieved clinical benefit (one partial response, five
stable disease) while none was observed in cAXL negative patients.
The study demonstrated a median progression-free survival among cAXL positive
patients in Cohort B patients of 4.73 months, compared with 1.87 months among
cAXL-negative patients.
Full details of the presentation are as follows:
Title: A PhII study of bemcentinib, a first-in-class selective AXL kinase
inhibitor, in combination with pembrolizumab in pts with previously-treated
advanced NSCLC: Updated clinical & translational analysis
Author: Professor James Spicer, Professor of Experimental Cancer Medicine at
King's College London
Session/Abstract ID: Combinatorial Therapies, 362
Date/Time: 11 November 2020, 11.40am EST
The presentation will be made available on BerGenBio's website, under
'Presentations (https://www.bergenbio.com/investors/presentations/)'.
- END -
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 expression defines a very poor prognosis
subgroup in most cancers. 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 Bemcentinib
Bemcentinib (formerly known as BGB324), 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. Bemcentinib targets and binds to the intracellular catalytic
kinase domain of AXL receptor tyrosine kinase and inhibits its activity.
Increase in AXL function has been linked to key mechanisms of drug resistance
and immune escape by tumour cells, leading to aggressive metastatic cancers.
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 focused on combination and single agent therapy in lung cancer,
leukaemia and COVID-19. A first-in-class functional blocking anti-AXL antibody,
tilvestamab, is undergoing phase I clinical testing. In parallel, BerGenBio is
developing companion diagnostic tests to identify 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). For more
information, visit 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
Mary-Jane Elliott, Chris Welsh, Lucy Featherstone, Carina Jurs
Consilium Strategic Communications
+44 20 3709 5700
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.
Building tools?
Free accounts include 100 API calls/year for testing.
Have a question? We'll get back to you promptly.