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2020-10-21 11:36:36
Bergen, Norway - 21 October 2020: BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical need, today announces that the first patient has been enrolled in the company sponsored Phase II clinical trial (BGBC020), assessing the efficacy and safety of bemcentinib for the treatment of hospitalised COVID-19 patients in South Africa and India. The Phase II study will recruit 120 hospitalised COVID-19 patients across five sites in South Africa and seven sites in India. 60 patients will receive bemcentinib (as monotherapy or in combination with standard of care medication) and 60 patients in a control group (receiving standard of care treatment only). The primary endpoint of the trial will be time to clinical improvement of at least two points (from randomisation) on a nine-point ordinal scale, or live discharge from the hospital, whichever comes first. The trial protocol will permit co-administration with other medicines recommended for treatment of COVID -19, including remdesivir and dexamethasone. A Data Monitoring Committee (DMC) formed of a group of independent experts external to the study has been established. The DMC will assess the progress, safety data and, critical efficacy endpoints of the trial as it proceeds. Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We are excited to continue exploring the profile of bemcentinib as a potential treatment for hospitalised COVID-19 patients and are delighted to announce that the study has commenced in South Africa. The region remains a geographical location of high incidence and we look forward to accelerating recruitment in South Africa and India, and providing further updates on our progress in due course." - END - 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 Contacts 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 20 3709 5700 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.