BERGENBIO ASA Bergen, Norway , 14 October 2020 -BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical need, announces that pre-clinical data on tilvestamab, the Company's novel function blocking, humanized anti-AXL antibody, will be presented at an ePoster presentation at the virtual 32[nd] EORTC NCI AACR (ENA) Symposium. The data presented shows that tilvestamab prevents AXL mediated cell signaling in cancer cell lines, reduces cell migration and invasion and shows anti-tumor efficacy in a panel of mouse xenograft models. Further it is shown that in a non -human primate dose-ranging toxicokinetic study, tilvestamab was well tolerated during dosing phase up to the highest studied dose of 25mg/kg. Tilvestamab is currently being evaluated in a Phase I clinical study (BGB149-101; NCT03795142) in healthy volunteers to evaluate safety, tolerability and pharmacokinetics. The meeting will run fromOctober 24-25 2020 and will be fully virtual, with further information available on the ENA website (https://event.eortc.org/ena2020/). Full details of the abstract are as follows: Title: Tilvestamab, a novel clinical stage humanized anti-AXL function blocking antibody Date:Saturday, October 24th 2020 Link to Abstract (https://cm.eortc.org/cmPortal/Searchable/ENA2020/config/normal#!abstra c tdetails/0000897260) - 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. AboutBerGenBio 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 inBergen, Norway with a subsidiary inOxford, UK . The company is listed on theOslo Stock Exchange (ticker: BGBIO). For more information, visit www.bergenbio.com ContactsRichard Godfrey CEO,BerGenBio ASA +47 917 86 304Rune Skeie , CFO,BerGenBio ASA rune.skeie@bergenbio.com +47 917 86 513 International Media RelationsMary-Jane Elliott ,Chris Welsh ,Lucy Featherstone ,Carina Jurs Consilium Strategic Communications bergenbio@consilium-comms.com +44 20 3709 5700 Media Relations inNorway 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.
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