Regulatory Filings • Mar 5, 2021
Regulatory Filings
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BERGENBIO ANNOUNCES START OF PHASE 1B TRIAL OF ANTI-AXL ANTIBODY TILVESTAMAB (BGB149)
Bergen, Norway, 5[th] March 2021?- BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical need, announces the first patient dosed in an international
Phase Ib trial investigating its first-in-class fully humanised anti-AXL
monoclonal antibody, tilvestamab (BGB149).
The objective of the study is to confirm safety, tolerability and determine a
recommended phase II dose (RP2D) for use in subsequent clinical trials. It is a
multiple ascending dose study, that will focus on establishing tilvestamab's
safety profile, tolerability and provide an insight into the dose proportional
response with respect to its effectiveness at modulating AXL expression, as
determined by BerGenBio's proprietary cAXL biomarker diagnostic assay.
The study will be conducted in patients with platinum resistant high-grade
serous ovarian cancer, in which AXL is frequently strongly over expressed. The
research will be conducted at specialist ovarian cancer centres able to perform
serial biopsies in these patients, and thereby providing a comprehensive
understanding of how tilvestamab modulates AXL expression in real time during a
treatment period.
Richard Godfrey, Chief Executive Officer of BerGenBio, said: "We understand that
AXL plays an important role in mediating the aggressive nature of this treatment
resistant cancer. From our Phase Ia study with tilvestamab that was completed
last year, we have an insight into its safety profile, and a safe starting dose
for this first-in-patient study. I am particularly excited that we are able to
conduct this state-of-the-art study collecting serial biopsies from patients
with a similar disease, which will provide high quality data on how tilvestamab
modulates AXL expression. This will inform how we can best use tilvestamab in a
future Phase II program.
-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 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 tilvestamab
Tilvestamab (BGB149) is a first-in-class, fully humanised, therapeutic anti-AXL
function blocking monoclonal antibody, discovered and 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.
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 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 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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