Regulatory Filings • Mar 30, 2021
Regulatory Filings
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BERGENBIO ANNOUNCES STOPPED RECRUITMENT TO THE BEMCENTINIB ARM IN UK ACCORD COVID PLATFORM TRIAL
Bergen, Norway, 30 March 2021?- BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical need, announces that recruitment to the bemcentinib arm of
the Phase two COVID-19 trial platform ACCORD, has been stopped today following
review by the Scientific Advisory Committee.
Due to the success of the vaccine roll out and public health measures taken in
the UK, COVID-19 case incidence has fallen rapidly, and the decision has been
made to halt UK recruitment at 30 patients and a similar number of matched
controls, enabling a prompt analysis of results. No safety concerns have been
identified.
BerGenBio's company sponsored Phase II trial (BGBC020), assessing the efficacy
and safety of bemcentinib for the treatment of COVID-19 in hospitalised patients
in South Africa and India, has completed recruitment. Data from the ACCORD study
and BerGenBio's Phase II COVID-19 trial study will be analysed separately and in
combination in a meta-analysis to inform next steps for this potential new
treatment.
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We are
grateful to the University of Southampton and the ACCORD clinical trial platform
for evaluating bemcentinib in hospitalised COVID-19 patients in the UK, the
cohort of 30 patients taking bemcentinib and matched controls will complement
our data sets for our similar study conducted in South Africa and India. We look
forward to closely reviewing the data generated from this trial, as well as from
our own study. We believe bemcentinib has great promise as a treatment for
COVID-19 complimentary to the ongoing global mass vaccination programs".
-Ends-
About ACCORD
The ACcelerating COVID-19 Research & Development (ACCORD) is a clinical trial
platform sponsored by Southampton University Hospital and is being funded by the
UK Research and Innovation (UKRI) with modest financial contribution by
BerGenBio and the other drug candidate contributing companies, to test potential
drugs through early stage clinical trials and feed them for consideration into
the UK's large-scale COVID-19 studies such as the RECOVERY trial
(https://www.nihr.ac.uk/urgent-public-health-research-studies-for-covid
-19/randomised-evaluation-of-covid-19-therapy-recovery/24513).
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 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 that leads to suppression of
the Type 1 Interferon immune response by host cells and in their environment.
Research data confirms 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 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 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 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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