Regulatory Filings • Jun 29, 2021
Regulatory Filings
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BERGENBIO PRESENTING COVID-19 DATA IN LATE-BREAKING ABSTRACT PRESENTATION AT ECCMID 2021
Bergen, Norway, 29 June 2021?- BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical need, today announces that its late-breaking abstract,
outlining Phase II clinical trial of bemcentinib, a first-in-class selective
oral AXL inhibitor, in hospitalised COVID-19 patients has been published at the
European Congress of Clinical Microbiology & Infectious Diseases (ECCMID),
taking place online from 9-12 July 2021.
The abstract outlines data from two randomised, open-label Phase II studies in
South Africa and India (BGBC020) and the UK (ACCORD2). 177 eligible patients
were enrolled across 3 countries in both studies between May 2020 and March 2021
in bemcentinib and SOC arms. Results showed that from baseline to day 29, there
were fewer deaths in the bemcentinib treated patients (2 of 58 and 1 of 28)
versus SOC (3 of 57 and 5 of 32) for BGBC020 and ACCORD2 respectively.
Bemcentinib was well tolerated throughout both studies.
These exploratory studies demonstrate encouraging evidence for the effect of
bemcentinib in hospitalised COVID-19 patients receiving steroids ± remdesivir.
Bemcentinib is an orally administered, well-tolerated AXL kinase inhibitor which
targets a host receptor to achieve antiviral effects; this mechanism is unlikely
to be attenuated by viral evolution.
Further analysis of the data will be shared in a presentation during the
congress, details below. The presentation will also be made available on the
Company website:
Presenting Author: Akil Jackson
Title: Bemcentinib, an oral AXL kinase inhibitor, results in lower mortality
compared to standard of care (steroids ± remdesivir) in hospitalised patients
with COVID-19
Session Name: LB: Interventions for improving COVID outcome
Session code: S191
Date: 12 July 2021
Time: 1:15 PM - 2:45 PM CEST
-Ends-
About AXL
AXL kinase is a cell membrane receptor and an essential mediator of the
biological mechanisms underlying life-threatening diseases.
In COVID-19, AXL has two synergistic mechanisms of action, it acts a co-receptor
to ACE2, to which the spike protein of the SARS-CoV-2 virus attaches and enters
the host cell, and AXL expression is upregulated in infected organs with an
activation of the signalling pathway leading to suppression of the Type 1
Interferon immune response by infected cells and neighbouring cells, in their
environment. Pre-clinical research studies demonstrate that bemcentinib inhibits
SARS-CoV-2 host cell entry and promotes anti-viral Type I interferon response.
In cancer, increase in AXL expression has been linked to key mechanisms of drug
resistance and immune escape by tumour cells, leading to aggressive metastatic
cancers. AXL suppresses the body's immune response to tumours and drives
treatment failure across many cancers. High AXL expression defines a very poor
prognosis subgroup in most cancers. AXL inhibitors, such as bemcentinib,
therefore, have potential high value as monotherapy and as the cornerstone 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 including fibrosis.
About Bemcentinib
Bemcentinib (formerly known as BGB324), is a potential first-in-class, potent
and highly selective AXL inhibitor, currently in a broad phase II clinical
development programme. It is administered as an oral capsule and taken once per
day. Ongoing clinical trials are investigating bemcentinib in COVID-19, and
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.
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 clinical development
programme focused on combination and single agent therapy in 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 a companion diagnostic test to identify
patient populations most likely to benefit from AXL inhibition: 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
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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