· Bergenbio in late stage set-up phase to sponsor and conduct a clinical study
using bemcentinib in a country of high COVID-19 incidence
Bergen, Norway, 28[th] July 2020 - BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
unmet medical need, notes the UK Research and Innovation's (UKRI) decision to
cease the grant funding to the University Hospital Southampton NHS Trust for the
COVID-19 ACCORD clinical study in which BerGenBio's bemcentinib was the lead
drug candidate to be tested. Subsequently the University Hospital Southampton
NHS Trust, who is the study sponsor, has notified all sites in the ACCORD study
to cease recruitment of new patients into the trial. Patients already
recruited, including those dosed with bemcentinib, will continue on treatment as
per the protocol.
Bergenbio also confirms it is in late stage set-up phase to sponsor and conduct
a similar study to ACCORD in a country of high COVID-19 incidence and expects to
be in a position to update the market in the near future.
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "Bemcentinib
still holds great potential for the treatment of COVID-19, hence its selection
by the UK Government for its urgent inclusion as the first drug to be dosed in
the ACCORD study. In recent weeks the incidence of COVID-19 in the UK has
drastically reduced and as a result the ACCORD programme hasn't moved forward as
swiftly as we expected. We are faced with the reality of the pandemic and need
to adapt quickly in order to move forward in the interests of patients.
"We look forward to sponsoring an oversees study and are pleased that we are
well positioned to do this important and rapid testing."
The ACcelerating COVID-19 Research & Development platform (ACCORD) study was
being funded by the Department of Health and Social Care (DHSC) and UK Research
and Innovation (UKRI) 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.
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.