Regulatory Filings • Nov 24, 2020
Regulatory Filings
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BERGENBIO CONFIRMS FIRST PATIENT ENROLLED IN PHASE II TRIAL ASSESSING BEMCENTINIB AS A POTENTIAL TREATMENT FOR COVID-19 IN INDIA
Bergen, Norway - 24[th] November 2020: BerGenBio ASA (OSE:BGBIO), a clinical
-stage biopharmaceutical company developing novel, selective AXL kinase
inhibitors for severe unmet medical need, today announces that the first patient
in India has been enrolled in the company sponsored Phase II clinical trial
(BGBC020), assessing the efficacy and safety of bemcentinib for the treatment of
hospitalised COVID-19 patients.
The Phase II study will recruit 120 hospitalised COVID-19 patients across seven
sites in India and five in South Africa. 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).
The primary endpoint of the trial will be time to clinical improvement of at
least two points (from randomisation) on a nine-point 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. A Data Monitoring Committee (DMC)
formed of a group of independent experts external to the study has been
established. The DMC will assess the progress, safety data and, critical
efficacy endpoints of the trial as it proceeds.
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We are
pleased to expand the BGBC020 study to patients in India, where incidences of
COVID-19 remain high, following the commencement of dosing in South Africa in
October. There are still no approved therapies for patients hospitalised as a
result of COVID-19 infection and we are keen to continue exploring the profile
of bemcentinib as a potential treatment."
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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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