Regulatory Filings • Oct 21, 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 PATIENTS IN SOUTH AFRICA
Bergen, Norway - 21 October 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 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 in South Africa and India.
The Phase II study will recruit 120 hospitalised COVID-19 patients across five
sites in South Africa and seven sites in India. 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 excited to continue exploring the profile of bemcentinib as a potential
treatment for hospitalised COVID-19 patients and are delighted to announce
that the study has commenced in South Africa. The region remains a geographical
location of high incidence and we look forward to
accelerating recruitment in South Africa and India, and providing further
updates on our progress in due course."
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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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