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· Significantly increased likelihood (88%) of shorter time to recovery or
discharge in higher severity cohort
· Clinical evidence of anti-viral mechanism of action
· Preclinical analysis highlights bemcentinib’s potential against COVID-19
variants
Bergen, Norway, 12 July 2021?- BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical need, has presented a combined analysis of data from two
Phase II studies investigating bemcentinib in hospitalised COVID-19 patients at
the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID).
Data was presented from the UKRI PhaseII ACCORD2 platform study, sponsored by
University Hospital Southampton, UK and BGBC020, BerGenBio’s open-label Phase II
study conducted in South Africa and India. In total, 179 eligible patients were
enrolled across both studies between May 2020 and March 2021, randomly allocated
on an open-label basis to treatment with bemcentinib in addition to standard of
care (SoC) compared to SoC alone. The two studies shared an identical design,
and combined data presented today showed encouraging survival benefit of 96.5%
vs 91.2%, with fewer deaths within 29 days of enrolment in bemcentinib treated
patients (1 of 30 and 2 of 58, 3.4%) versus SoC (5 of 34 and 3 of 57, 8.8%),
respectively.
As previously reported for BGBC020, a post-hoc analysis identified a sub-group
of patients with higher disease severity on enrolment within 24 hours of
admission to hospital in whom evidence of a treatment benefit with bemcentinib
was observed. Patients in the subgroup were receiving oxygen (Grade 4) or non
-invasive ventilation (Grade 5) and recorded serum levels of the inflammatory
marker C-Reactive Protein (CRP) greater than 30mg/L. This subgroup represents
more than 60% of the patients in the combined study population, and the
previously reported treatment benefit in this group of patients in India and
South Africa is reproduced in analysis of the patients studied in the UK.
Across both studies, evaluation of the primary endpoint of time to recovery or
discharge, in this defined patient subgroup with higher baseline disease
severity, showed there was a statistically significant greater likelihood of
faster time to recovery or hospital discharge with bemcentinib added to SoC,
compared to SoC alone; 88% greater than SoC, representing a hazard ratio of 1.88
95% confidence intervals (1.24, - 2.87) log-rank p=0.003 (not adjusted for
multiple comparisons).
A 69% lower likelihood of progression of patients to need for any form of
increased ventilatory assistance from enrolment, or to death, within 29 days,
was also observed with statistical significance in this higher severity subgroup
treated with bemcentinib, compared to SoC alone. A hazard ratio of 0.31 (95%
C.I. 0.12, 0.78), log-rank p=0.0088 unadjusted for multiple comparisons was
shown. This benefit of bemcentinib on ventilator-free survival was observed in
rates of admission to Intensive Care in the UK study; four patients (14%)
treated with bemcentinib in addition to SoC, compared to ten (31%) of matched
eligible patients treated with SoC alone.
Bemcentinib was well tolerated throughout both studies. An independent data
monitoring committee has reviewed each study and concluded there is no evidence
of safety concerns from the Phase II evaluation in COVID-19 patients.
In a separate preclinical analysis, bemcentinib’s mechanism of action has been
shown to be independent of the SARS-CoV-2 spike protein. In vitro analysis of
alpha and beta COVID-19 virus variants has shown continued bemcentinib efficacy.
Professor Tom Wilkinson MA Cantab MBBS PhD FRCP FERS, Professor of Respiratory
Medicine and Chief Investigator on the ACCORD programme commented: “This
encouraging data demonstrates bemcentinib’s novel mechanism of action, which
appears to have efficacy independent of the SARS-CoV-2 spike protein, which
could be significant with the emergence of new and potentially vaccine resistant
variants of the virus. The result of the combined analysis underlines the
potential for bemcentinib to treat a substantial portion of hospitalised COVID
-19 patients, offering a survival benefit.”
Richard Godfrey, CEO of BerGenBio, commented: “We are pleased to present these
encouraging data at ECCMID. As the data has matured, we can see that
bemcentinib offered a survival benefit to patients and we remain confident that
bemcentinib could prove a valuable treatment option for patients severely
affected by COVID-19 and reduce their need for ventilation for recovery. We’ll
continue to provide updates as our development activities to treat COVID-19
patients evolve.”
Presentation details
Presenting author: Akil Jackson
Title: Bemcentinib, an oral AXL kinase inhibitor, results in lower mortality
compared to standard of care (steroids with or without remdesivir) in
hospitalised patients with COVID-19
Session name: LB: Interventions for improving COVID outcome
Session code: S191
Date: 12 July 2021
Recording will be available for registered attendees to the conference from the
day after presentation for three months.
-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
ir@bergenbio.com
Richard Godfrey CEO, BerGenBio ASA
Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com
+47 917 86 513
International Media Relations
Mary-Jane Elliott, Chris Welsh, Lucy Featherstone, Carina Jurs
Consilium Strategic Communications
bergenbio@consilium-comms.com
+44 20 3709 5700
Media Relations in Norway
Jan Petter Stiff, Crux Advisers
stiff@crux.no
+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 considered to be inside information pursuant to the EU
Market Abuse Regulation and is subject to the disclosure requirements pursuant
to section 5-12 of the Norwegian Securities Trading Act.
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