Regulatory Filings • Sep 7, 2021
Regulatory Filings
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BERGENBIO COMPLETES RECRUITMENT OF PHASE II AML STUDY (BGBC003)
Bergen, Norway, 7 September 2021?- BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical needs, is pleased to announce the completion of patient
recruitment into BGBC003 (ClinicalTrials.gov ID: NCT02488408), a Phase Ib/II
multicenter open-label study of bemcentinib as a single agent and in combination
with cytarabine or decitabine in patients with Acute Myeloid Leukemia (AML) or
as a single agent in patients with myelodysplastic syndrome (MDS).
BerGenBio has recruited a total of 86 patients in cohort B, with between 14 and
18 patients in each of the cohorts B1-B4 and 20 patients in cohort B5, as per
protocol.
In June 2021, the latest study data was published at the European Haematology
Association (EHA) Meeting, which indicated that the combination of bemcentinib
and low dose cytarabine (LDAC) is efficacious and well tolerated in relapsed
elderly AML patients unfit for intensive chemotherapy, with an overall response
rate of 31% (5/16) and median overall survival of 13.3 months. The encouraging
preliminary survival data reported showed that the addition of bemcentinib more
than doubled the historic survival rates seen with standard of care treatment in
this patient population.
An in-depth translational research program to identify predictive molecular and
biological factors associated with response is ongoing.
Dialogue continues with the regulatory agencies in the US and Europe to align on
a pathway for a pivotal registration trial for the bemcentinib/LDAC combination
in relapsed elderly AML patients unfit for intensive chemotherapy.
Rune Skeie, Interim Chief Executive Officer, said: "We are pleased to have
completed enrolment of the BGBC003 study and now look forward to delivering our
full analysis of the data from this important trial. There is a significant
unmet need for an effective therapy for relapsed elderly AML patients unfit for
intensive chemotherapy, for whom there are currently few treatment options
available. With encouraging data shown so far, we will continue dialogue with
the regulators towards progressing bemcentinib in this indication."
Prof. Dr. Sonja Loges, Chief Investigator of the trial, commented: "We have been
very encouraged by the positive responses observed so far in relapsed AML
patients with many patients remaining on bemcentinib for extended durations.
With the trial fully recruited, we hope that data gathered will prove useful in
the continued exploration of bemcentinib's potential efficacy in AML, as well as
helping us identify predictive biomarkers that may help identify patients most
likely to benefit from this approach."
-Ends-
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 in infected organs with an
activation of the signalling pathway leading to suppression of the Type 1
Interferon immune response by infected cells and neighbouring cells, in their
environment. Pre-clinical research studies demonstrate that 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 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 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 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
Rune Skeie, Interim CEO, 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
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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