BerGenBio

Regulatory Filings • Apr 29, 2020

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

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.