Regulatory Filings • Jan 29, 2021
Regulatory Filings
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BERGENBIO PRESENTS UPDATES FROM ONGOING PHASE II BEMCENTINIB COMBINATION STUDY IN REFRACTORY NSCLC AT WCLC 2020
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Bemcentinib in combination with pembrolizumab was well-tolerated and
showed promising clinical activity in refractory lung cancer
Bergen, Norway, 29 January 2021?- BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical need, will today present an update from its Phase II study
of bemcentinib in combination with anti-PD-1 therapy pembrolizumab (BGBC008) in
refractory non-small cell lung cancer (NSCLC) patients at an oral
presentation at the 2020 World Conference on Lung Cancer Singapore (WCLC).
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.?Recruitment is ongoing in
these patient populations.
The primary endpoint of the study is Overall Response Rate, with pre-defined
criteria to proceed from the first to second stage in each cohort. Secondary
endpoints include Disease Control Rate, Progression Free Survival,
Overall Survival and safety.
Interim data from Cohort B showed that the overall response rate among the seven
evaluable cAXL positive patients was 14% with a disease control rate of 86% and
a 2.5-fold improvement in progression free survival rate in the cAXL positive
patients. In the seven cAXL negative patients, all showed clinical
progression with 29% of patients demonstrating clinical benefit following
treatment. The interim data shows that bemcentinib in combination with
pembrolizumab was well-tolerated and shows promising clinical activity in
refractory lung cancer. Furthermore, whole tumour gene
expression analysis identified an AXL positive gene
signature characteristic of an immune suppression mechanism, in patients
with acquired (Cohort B) resistance to CPIs.
Dr. Matthew Krebs, who will deliver the presentation at WCLC
commented: "These promising interim data suggest that bemcentinib is well
tolerated in these vulnerable patient groups and may reverse acquired resistance
to checkpoint inhibition by targeting AXL positive macrophages and regulatory
dendritic cells. These findings support further development of AXL inhibition
with bemcentinib to extend efficacy of immunotherapy in biomarker-selected
refractory NSCLC."
The full abstract can be found on the
WCLC website (https://library.iaslc.org/conference
-program?product_id=20&author=&category=&date=&session_type=&session=&presentatio
n=&keyword=bemcentinib&cme=undefined&), and details of the presentation are
below.
Title: A phase II study of the oral selective AXL inhibitor bemcentinib with
pembrolizumab in refractory patients with advanced NSCLC
Presenting Author: Dr. Matthew G. Krebs PhD.
Session/Abstract ID: Immunotherapy (Phase II/III Trials) / # 3647
Date/Time: Friday 29th January 2021 at 09.50 Singapore Time / 02.50 CET
The presentation will be available on BerGenBio's website from 29th January
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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.
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