Bergen, Norway - 24[th] November 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 />
in India has been enrolled in the company sponsored Phase II clinical trial<br
/>
(BGBC020), assessing the efficacy and safety of bemcentinib for the treatment
of<br />
hospitalised COVID-19 patients.<br />
<br />
The Phase II study will recruit 120 hospitalised COVID-19 patients across
seven<br />
sites in India and five in South Africa. 60 patients will receive bemcentinib<br
/>
(as monotherapy or in combination with standard of care medication) and 60<br />
patients in a control group (receiving standard of care treatment only).<br />
<br />
The primary endpoint of the trial will be time to clinical improvement of at<br
/>
least two points (from randomisation) on a nine-point ordinal scale, or live<br
/>
discharge from the hospital, whichever comes first. The trial protocol will<br
/>
permit co-administration with other medicines recommended for treatment of
COVID<br />
-19, including remdesivir and dexamethasone. A Data Monitoring Committee
(DMC)<br />
formed of a group of independent experts external to the study has been<br />
established. The DMC will assess the progress, safety data and, critical<br />
efficacy endpoints of the trial as it proceeds.<br />
<br />
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We are<br />
pleased to expand the BGBC020 study to patients in India, where incidences of<br
/>
COVID-19 remain high,  following the commencement of dosing in South Africa
in<br />
October. There are still no approved therapies for patients hospitalised as a<br
/>
result of COVID-19 infection and we are keen to continue exploring the
profile<br />
of bemcentinib as a potential treatment."<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.