Regulatory Filings • Sep 11, 2020
Regulatory Filings
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BERGENBIO RECEIVES APPROVAL TO COMMENCE PHASE II TRIAL OF BEMCENTINIB FOR COVID-19 IN SOUTH AFRICA
Bergen, Norway, 11 September 2020 - BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical need, announces that it has received regulatory approval
from the South African Health Products Regulatory Authority (SAHPRA) to proceed
with a company sponsored Phase II clinical trial to assess the efficacy and
safety of bemcentinib for the treatment of COVID-19 in hospitalised patients.
The study will enrol 120 hospitalised COVID-19 patients. 60 patients will
receive bemcentinib (as monotherapy or in combination with standard of care
medication) and 60 patients in a control group (receiving standard of care
treatment only), across five sites in South Africa, with the first patients due
to be treated imminently, pending clearance by the Norwegian Regional Ethics
Committee.
The primary endpoint of the trial will be time to clinical improvement of at
least two points (from randomisation) on a nine-point category ordinal scale, or
live discharge from the hospital, whichever comes first. The trial protocol will
permit co-administration with other medicines recommended for treatment of COVID
-19, including remdesivir and dexamethasone.
BerGenBio also confirms it is in late stage set-up phase to expand the study to
include additional hospital sites in India, and expects to be in a position to
update the market in the near future.
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "Preclinical
data shows that bemcentinib holds great potential for the treatment of COVID-19.
Based on our experience in the ACCORD study there is no reason for us to believe
bemcentinib will not be of benefit to COVID-19 patients; with falling rates of
COVID-19 incidence in Europe over recent months, we have moved quickly, shifting
our focus in the interests of patients to geographies with a high number of
cases in order to address this urgent unmet medical need. With infection rates
still high in many countries including South Africa and India, we are reminded
there is still no approved treatment or cure for this disease. We expect to dose
the first patients in South Africa imminently, and accelerate patient
recruitment rapidly with the planned expansion to include patients in India and
look forward to providing further updates on our progress."
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About AXL
AXL kinase is a cell membrane receptor and an essential mediator of the
biological mechanisms underlying many 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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