Regulatory Filings • May 12, 2021
Regulatory Filings
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BERGENBIO TO PRESENT UPDATED CLINICAL DATA AT EUROPEAN HEMATOLOGY ASSOCIATION (EHA) 2021 VIRTUAL MEETING
Bergen, Norway, 12 May 2021?- BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical need, is pleased to announce that its abstract has been
accepted for an e-poster presentation at the European Hematology Association
(EHA) 2021 Virtual Meeting, taking place from 9-17 June 2021.
The poster will provide an update from the Company's Phase II study of
bemcentinib (BGBC003) in combination with low dose cytarabine (LDAC) in elderly
relapsed AML patients.
Full abstracts have been announced online with details as follows:
Abstract Title: The combination of AXL Inhibitor Bemcentinib and low-dose
Cytarabine is well tolerated and efficacious in elderly relapsed AML patients:
update from the ongoing BGBC003 Phase II Trial (NCT02488408)
Abstract Number: EHA-2859
Session: 04. Acute Myeloid Leukaemia - Clinical
Link to online abstract: https://ehaweb.org/congress/eha-congress
-2021/program/featured-sessions/
The e-poster presentation will be made available at the EHA website from 11 June
at 9am CEST.
The poster presentation will also be made available at BerGenBio's website
www.bergenbio.com.
-Ends-
About AML and the BGBC003 trial
Acute myeloid leukaemia (AML) is a rapidly progressing blood cancer. AML is the
most common form of acute leukaemia in adults, where malignant AML blasts
interfere with the normal functioning of the bone marrow leading to a multitude
of complications like anaemia, infections and bleeding. AML is diagnosed in over
20,000 patients in the US annually and is rapidly lethal if left untreated.
Successful treatment typically requires intensive chemotherapy or bone marrow
transplantation, and relapse and resistance are common. Consequently, there is
an urgent need for effective novel therapies in relapsed/refractory patients,
particularly those that are ineligible for intensive therapy or bone marrow
transplant.
The BGBC003 trial is a phase Ib/II multi-centre open label study of bemcentinib
in combination with cytarabine (part B2) and low dose decitabine (part B3 & B5)
in patients with AML who are unsuitable for intensive chemotherapy as a result
of advanced age or existing-co-morbidities.
For more information please access trial NCT02488408 at www.clinicaltrials.gov.
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 that leads to suppression of
the Type 1 Interferon immune response by host cells and in their environment.
Research data confirms bemcentinib inhibits SARS-CoV-2 host cell entry and
promotes the 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
Richard Godfrey CEO, BerGenBio ASA
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 [email protected]
+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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