Regulatory Filings • Feb 8, 2021
Regulatory Filings
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SECOND DATA MONITORING COMMITTEE RECOMMENDS CONTINUATION OF BERGENBIO'S BGBC020 TRIAL ASSESSING BEMCENTINIB IN COVID-19 PATIENTS
Bergen, Norway, 8[th ]February 2021 - BerGenBio ASA (OSE:BGBIO), a clinical
-stage biopharmaceutical company developing novel, selective AXL kinase
inhibitors for severe unmet medical need, provides an update on 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, following the second meeting of the trial's independent Data
Monitoring Committee (iDMC).
The iDMC, formed from a group of independent infectious disease clinical experts
external to the study, maintained its recommendation that the trial should
continue as planned with no changes, as no safety concerns were raised from the
available data. The iDMC will continue to assess the safety data and critical
efficacy endpoints of the trial, as it progresses.
The Phase II BGBC020 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
treatment) 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.
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We continue
to have confidence in the favourable safety profile of bemcentinib, and are
pleased that the iDMC continues to recommend the continuation of the BGBC020
trial. We look forward to recording further data. We are hopeful that
bemcentinib can play a role in the global effort to find an effective treatment
option for hospitalised COVID-19 patients, particularly as we continue to see an
increase in incidence of the virus in many areas of the world."
- END -
About AXL
AXL kinase is a cell membrane receptor and an essential mediator of the
biological mechanisms underlying 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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