BERGENBIO'S BEMCENTINIB SELECTED TO BE FAST-TRACKED AS POTENTIAL TREATMENT FOR COVID-19 THROUGH NEW NATIONAL UK GOVERNMENT CLINICAL TRIAL INITIATIVE

 

· Bemcentinib selected as first candidate to be tested through new ACCORD study
  · The Phase II clinical trial initiative to rapidly investigate bemcentinib's
efficacy and safety in hospitalised COVID-19 patients
  · Study to be funded by the UK Department of Health and Social Care and UK
Research and Innovation
  · Study to be managed by CRO, IQVIA
  · BerGenBio will be hosting a webcast at 10.00 CEST tomorrow (see details
below)

Bergen, Norway, 29 April 2020 - BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
unmet medical need, announces that bemcentinib has been selected as the first
potential treatment to be fast-tracked in a new UK national multi-centre
randomised Phase II clinical trial initiative that aims to save lives and get an
early indication of bemcentinib's effectiveness in treating the most vulnerable
patients with COVID-19.

The ACcelerating COVID-19 Research & Development platform (ACCORD) study is
being funded by the Department of Health and Social Care (DHSC) and UK Research
and Innovation (UKRI). ACCORD brings together a single, UK-wide clinical trial
platform provided by the clinical research company IQVIA and the UK's leading
research expertise through the National Institute for Health Research, to
rapidly test potential drugs through early stage clinical trials and feed them
into the UK's large-scale COVID-19 studies such as the RECOVERY
trial (https://www.nihr.ac.uk/urgent-public-health-research-studies-for-covid
-19/randomised-evaluation-of-covid-19-therapy-recovery/24513), currently the
world's largest randomised controlled clinical trial for COVID-19 treatment.

ACCORD COVID-19 trial

The ACCORD study is a multicentre, seamless, Phase II adaptive randomisation
platform trial to assess the efficacy and safety of multiple candidate agents,
the first of which is bemcentinib, for the treatment of COVID-19 in hospitalised
UK NHS patients.

The study, with drug material and trial resources provided by BerGenBio, will
rapidly commence testing in 120 subjects (60 hospitalised COVID-19 patients and
60 control group patients receiving standard of care treatment) across 6 UK NHS
hospital trusts, with the first patients due to be treated imminently. BerGenBio
anticipates that top line data will readout within a few months. Data will be
open source and freely available to enable global knowledge sharing and
collaboration. If positive results are seen, bemcentinib will advance rapidly
into the large-scale Phase III trials currently in progress across the UK.

Bemcentinib's applicability to treat COVID-19

COVID-19 is the clinical disease manifested as a result of SARS-CoV-2
coronavirus infection, responsible for the current COVID-19
pandemic. Preclinical data suggest that bemcentinib is potentially useful for
the treatment of early SARS-CoV-2 infection. There are currently no approved
medical treatments for, or vaccines against, COVID-19.

Bemcentinib is a once-a-day, oral, highly selective and potent inhibitor of AXL
kinase being developed by BerGenBio. Bemcentinib has previously demonstrated a
key role in cancer treatment: preventing immune evasion, drug resistance and
metastasis in a variety of cancer trials. The drug has to date been shown to be
safe and well-tolerated in hundreds of patients and in many cases taken daily
for several years.

Bemcentinib has previously been reported to exhibit potent anti-viral activity
in preclinical models against several enveloped viruses, including Ebola and
Zika virus. Recent data have expanded this to SARS-CoV-2.[1, 2]

Bemcentinib selectively inhibits AXL kinase activity, blocking viral entry and
enhancing the anti-viral type I interferon response, a key cellular defence
mechanism against viral infection.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We are
delighted to be part of this initiative which is a ground-breaking partnership
between government, academia and industry.  We are hopeful that bemcentinib can
play a significant role in the global effort to find suitable treatment options
for COVID-19 patients, which has had such serious implications for so many
people and thereby ease pressures on hospital intensive care units, and
ultimately treat thousands of patients. We are poised to commence dosing in the
coming days and will provide results as soon as is practically possible."

Health and Social Care Secretary, Matt Hancock, said: "Currently no drugs in the
world have been clinically proven to treat Covid-19. But our Therapeutics
Taskforce has identified a number of promising candidates. Currently, six
different treatments have been entered into national clinical trials and the
first is ready to enter the next stage: a new early phase clinical trial
platform that we are launching today. This is a national effort made possible by
government, academia and industry working together."

Professor Tom Wilkinson, ACCORD clinical academic lead based at the National
Institute for Health Research (NIHR) Southampton Biomedical Research Centre,
said: "There has been a tremendous effort to pull this initiative together so
rapidly. ACCORD is a national effort and will be key to developing effective new
treatments which are needed so desperately. The ACCORD platform will be able to
rapidly test potential new treatments, advancing the most promising through
Phase 2 clinical trials into the NHS. This unique national platform for
developing new COVID-19 drug candidates will access the world-class expertise
and resources of the NIHR Respiratory Translational Research Collaboration and
allied centres nationwide."

ACCORD is part of a co-ordinated therapeutic development pathway that the
Government has put in place, overseen by the Department for Business, Energy and
Industrial Strategy and delivered by UKRI, as part of the overall Therapeutics
Taskforce.

References

[1 ]Dowall SD et al. Antiviral Screening of Multiple Compounds against Ebola
Virus. Viruses 2016, 8:27

[2] Meertens L et al. Axl mediates ZIKA virus entry in human glial cells and
modulates innate immune responses. Cell Rep 2017 18:324

Presentation and webcast tomorrow

BerGenBio will be hosting a live webcast and Q&A session at 10.00 CEST today, 29
April:

Webcast link: https://channel.royalcast.com/webcast/hegnarmedia/20200429_9/

Dial-in numbers:

  · NO:  +47 2195 6342
  · UK:  +44 203 769 6819
  · US:  +1 646 787 0157

PIN:  569168

The presentation will also be made available at www.bergenbio.com/investors, and
the recording will be available shortly after the webcast has finished.

About BerGenBio

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 oncology clinical development
programme focused on combination and single agent therapy in lung cancer and
leukaemia. A first-in-class functional blocking anti-AXL antibody, tilvestamab,
is undergoing Phase I clinical testing. In parallel, BerGenBio is developing
companion diagnostic tests to identify those patient populations most likely to
benefit from bemcentinib: 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

For more information, please contact

Richard Godfrey CEO, BerGenBio ASA
+47 917 86 304

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 7780 600290

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 subject to the disclosure requirements pursuant to section 5
-12 of the Norwegian Securities Trading Act.
 

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