Bergen, Norway - 8[th] December 2020: BerGenBio ASA (OSE:BGBIO), a clinical<br
/>
-stage biopharmaceutical company developing novel, selective AXL kinase<br />
inhibitors for severe unmet medical need, today announces that the first
patient<br />
has been enrolled with bemcentinib in the UK Research and Innovation (UKRI)<br
/>
funded COVID-19 ACCORD clinical study.<br />
<br />
The ACCORD study is a multicentre, seamless, Phase II adaptive randomisation<br
/>
platform trial to assess the efficacy and safety of multiple candidate
agents,<br />
the first of which is bemcentinib, for the treatment of COVID-19 in
hospitalised<br />
UK NHS patients. Funding for the study was suspended by UKRI in July due to
the<br />
falling number of hospitalised COVID-19 patients across UK trial sites but<br />
reinstated in September 2020 following a rise in the number of cases across
the<br />
UK.<br />
<br />
BerGenBio will make a modest financial contribution to the cost for the study<br
/>
and provide bemcentinib drug material. 60 hospitalised COVID-19 patients will<br
/>
receive bemcentinib and 60 patients in a control group will receive standard
of<br />
care treatment. The trial protocol will permit enrolled patients with
COVID-19,<br />
who meet the inclusion criteria for the study, to potentially receive<br />
bemcentinib plus one or both of the two recently recommended treatments for<br
/>
COVID-19: dexamethasone and remdesivir.<br />
<br />
Data will be open source and freely available to enable global knowledge
sharing<br />
and collaboration. Data previously gathered before the cessation of the trial
in<br />
July will be included in the analysis.<br />
<br />
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "With the<br
/>
incidence of COVID-19 cases in the UK and globally still high with no
approved<br />
treatment, there is still an urgent need for effective treatments options for<br
/>
hispitalised patients. We believe bemcentinib has great promise and we are<br />
pleased to see the treatment of patients commence again in the UK trial."<br />
<br />
- END -<br />
<br />
About AXL<br />
<br />
AXL kinase is a cell membrane receptor and an essential mediator of the<br />
biological mechanisms underlying many life-threatening diseases. In cancer,
AXL<br />
suppresses the body's immune response to tumours and drives cancer treatment<br
/>
failure across many indications. AXL expression defines a very poor prognosis<br
/>
subgroup in most cancers. AXL inhibitors, therefore, have potential high
value<br />
at the centre of cancer combination therapy, addressing significant unmet<br />
medical needs and multiple high-value market opportunities. Research has also<br
/>
shown that AXL mediates other aggressive diseases.<br />
<br />
About Bemcentinib<br />
<br />
Bemcentinib (formerly known as BGB324), is a potentially first-in-class<br />
selective AXL inhibitor in a broad phase II clinical development programme.<br
/>
Ongoing clinical trials are investigating bemcentinib in multiple solid and<br
/>
haematological tumours, in combination with current and emerging therapies<br />
(including immunotherapies, targeted therapies and chemotherapy), and as a<br />
single agent. Bemcentinib targets and binds to the intracellular catalytic<br />
kinase domain of AXL receptor tyrosine kinase and inhibits its activity.<br />
Increase in AXL function has been linked to key mechanisms of drug resistance<br
/>
and immune escape by tumour cells, leading to aggressive metastatic cancers.<br
/>
<br />
About BerGenBio ASA<br />
<br />
BerGenBio is a clinical-stage biopharmaceutical company focused on developing<br
/>
transformative drugs targeting AXL as a potential cornerstone of therapy for<br
/>
aggressive diseases, including immune-evasive, therapy resistant cancers. The<br
/>
company's proprietary lead candidate, bemcentinib, is a potentially first-in<br
/>
-class selective AXL inhibitor in a broad phase II oncology clinical
development<br />
programme focused on combination and single agent therapy in lung cancer,<br />
leukaemia and COVID-19. A first-in-class functional blocking anti-AXL
antibody,<br />
tilvestamab, is undergoing phase I clinical testing. In parallel, BerGenBio
is<br />
developing companion diagnostic tests to identify patient populations most<br />
likely to benefit from bemcentinib: this is expected to facilitate more<br />
efficient registration trials supporting a precision medicine-based<br />
commercialisation strategy.<br />
<br />
BerGenBio is based in Bergen, Norway with a subsidiary in Oxford, UK. The<br />
company is listed on the Oslo Stock Exchange (ticker: BGBIO). For more<br />
information, visit www.bergenbio.com<br />
<br />
Contacts<br />
<br />
Richard Godfrey CEO, BerGenBio ASA<br />
+47 917 86 304<br />
<br />
Rune Skeie, CFO, BerGenBio ASA<br />
rune.skeie@bergenbio.com<br />
+47 917 86 513<br />
<br />
International Media Relations<br />
<br />
Mary-Jane Elliott, Chris Welsh, Lucy Featherstone, Carina Jurs<br />
<br />
Consilium Strategic Communications<br />
bergenbio@consilium-comms.com<br />
+44 20 3709 5700<br />
<br />
Media Relations in Norway<br />
<br />
Jan Petter Stiff, Crux Advisers<br />
<br />
stiff@crux.no<br />
+47 995 13 891<br />
<br />
Forward looking statements<br />
<br />
This announcement may contain forward-looking statements, which as such are
not<br />
historical facts, but are based upon various assumptions, many of which are<br
/>
based, in turn, upon further assumptions. These assumptions are inherently<br />
subject to significant known and unknown risks, uncertainties and other<br />
important factors. Such risks, uncertainties, contingencies and other
important<br />
factors could cause actual events to differ materially from the expectations<br
/>
expressed or implied in this announcement by such forward-looking statements.<br
/>
<br />
This information is subject to the disclosure requirements pursuant to section
5<br />
-12 of the Norwegian Securities Trading Act.