Earnings Release • Jun 7, 2021
Earnings Release
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BERGENBIO TO PRESENT PRECLINICAL DATA ON TILVESTAMAB IN CHRONIC KIDNEY DISEASE AT ERA-EDTA VIRTUAL CONGRESS 2021
Bergen, Norway, 7 June 2021 - BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical need, is pleased to present preclinical data on its first
-in-class, fully humanised, therapeutic anti-AXL function blocking monoclonal
antibody, tilvestamab, in chronic kidney disease at the European Renal
Association - European Dialysis and Transplant Association (ERA-EDTA) Virtual
Congress.
This preclinical study was conducted to characterise AXL as a target in chronic
kidney disease (CKD) and to investigate the anti-fibrotic efficacy of
tilvestamab using an ex vivo model of human Precision Cut Kidney Slices (PCKSs).
The study results showed that AXL expression was induced in key cell populations
during the development of kidney fibrosis in the unilateral ureteric-outflow
obstruction (UUO) model of kidney fibrosis in mice. In an ex vivo model using
human Precision Cut Kidney Slices (PCKSs), tilvestamab dose-dependently reduced
the levels of ?SMA, a marker of myofibroblast activation. When combined with
the ACE inhibitor enalapril, tilvestamab synergized to reduce ?SMA levels
further as well as reducing secreted Collagen 1a1. This data supports AXL as a
novel target in CKD and highlights the potential of tilvestamab as a promising
candidate for pharmacologic intervention in kidney fibrosis, with potential
synergies with current reno-protective therapies warranting further exploration.
Read the full abstract on the ERA-EDTA website here: https://www.era
-edta.org/en/virtualcongress2021/ndt-abstracts-book/
Details of the presentation are as follows:
Title: Tilvestamab, a function-blocking monoclonal antibody inhibitor of AXL RTK
signalling, limits the onset of renal fibrotic changes in human kidneys ex vivo
Session: Renal pathology. Experimental and clinical
Abstract ID: MO074
Date/Time: 05/06/2021 08:00
Author: Linn Hodneland Nilsson
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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. Data from a Phase II
in human clinical trial has shown that treatment with AXL inhibitor bemcentinib
increased the rate of ventilator free survival in hospitalised COVID-19
patients.
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 Tilvestamab
Tilvestamab (BGB149) is a first-in-class, fully humanised, therapeutic anti-AXL
function blocking monoclonal antibody, developed by BerGenBio. A Phase Ia study
in healthy volunteers has been completed. Pre-clinical data has shown that
tilvestamab prevents AXL mediated cell signalling in cancer models, reduces cell
migration and invasion and shows anti-tumour efficacy.
An international Phase Ib first-in-patient trial investigating tilvestamab
(BGB149) is currently ongoing with the objective to confirm safety, tolerability
and determine a recommended phase II dose (RP2D) for use in subsequent clinical
trials.
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
+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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