Regulatory Filings • Sep 28, 2020
Regulatory Filings
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ACCORD CLINICAL STUDY ASSESSING BEMCENTINIB IN COVID-19 PATIENTS TO RECOMMENCE IN UK
Bergen, Norway, 28 September 2020 - BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
unmet medical need, notes that following a rise in the number of COVID-19 cases
in the UK, UK Research and Innovation (UKRI) has decided to reinstate funding
for the COVID-19 ACCORD clinical study in which BerGenBio's bemcentinib is the
lead drug candidate to be tested.
The University Hospital Southampton NHS Trust remains the study sponsor, however
the trial will be managed by the Medicines Evaluation Unit at Manchester
University. Three drug candidates will be evaluated in the trial, it is
anticipated that up to 25 UK sites in the ACCORD study will recruit patients
into the trial and that patient recruitment will recommence within weeks.
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. Funding for the study was suspended by UKRI in July due to the
falling number of hospitalised COVID-19 patients across UK trial sites.
BerGenBio will make a modest financial contribution to the cost for the study
and provide bemcentinib drug material. 60 hospitalised COVID-19 patients will
receive bemcentinib and 60 patients in a control group will receive standard of
care treatment. The trial protocol will permit enrolled patients with COVID-19,
who meet the inclusion criteria for the study, to potentially receive
bemcentinib plus one or both of the two recently recommended treatments for
COVID-19: dexamethasone and remdesivir.
Data will be open source and freely available to enable global knowledge sharing
and collaboration. Data previously gathered before the cessation of the trial in
July will be included in the analysis.
BerGenBio has also received full regulatory and ethics clearance for its company
sponsored Phase II trial (BGBC020) to assess the efficacy and safety of
bemcentinib for the treatment of COVID-19 in hospitalised patients in South
Africa and dosing is due to commence imminently. The Company is also in late
stage set-up phase to expand the study to include additional hospital sites in
India and expects to be in a position to update the market in the near future.
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "In recent
weeks COVID-19 infection rates have unfortunately increased rapidly in the UK.
With still no approved treatment or cure in place, and the hospitalised patient
population now becoming large enough to support the trial, the decision has been
taken to reinstate the ACCORD programme to continue investigating the potential
of bemcentinib and two other agents as treatments for COVID19 patients. We
believe bemcentinib has great promise and welcome the opportunity to recommence
participation in the UK trial. We also look forward to continuing our own
studies, using a similar protocol, in South Africa and India."
- END -
About ACCORD
The ACcelerating COVID-19 Research & Development platform (ACCORD) study is
being funded by the UK Research and Innovation (UKRI) with modest financial
contribution by BerGenBio and the other drug candidate contributing companies,
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 AXL
AXL kinase is a cell membrane receptor and an essential mediator of the
biological mechanisms underlying many life-threatening diseases. In cancer, AXL
suppresses the body's immune response to tumours and drives cancer treatment
failure across many indications. AXL expression defines a very poor prognosis
subgroup in most cancers. AXL inhibitors, therefore, have potential high value
at the centre 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.
About Bemcentinib
Bemcentinib (formerly known as BGB324), is a potentially first-in-class
selective AXL inhibitor in a broad phase II clinical development programme.
Ongoing clinical trials are investigating bemcentinib in 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.
Increase in AXL function has been linked to key mechanisms of drug resistance
and immune escape by tumour cells, leading to aggressive metastatic cancers.
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 oncology 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 companion diagnostic tests to identify 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
About The Medicines Evaluation Unit (MEU)
The Medicines Evaluation Unit (MEU) is a leading specialist clinical research
facility working with the pharmaceutical industry to identify potential new
treatments for respiratory disease and conditions such as Asthma, COPD, Cystic
Fibrosis, Hypertension, Psoriasis. MEU has an outstanding reputation within the
industry for performing high quality clinical research complying with strict
clinical trial legislation. MEU has successfully conducted over 360 clinical
trials.
Contacts
Richard Godfrey CEO, BerGenBio ASA
+47 917 86 304
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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