BERGENBIO ANNOUNCES CHANGES TO SENIOR MANAGEMENT
Bergen, Norway, 6 August 2021 – BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical need, today announces changes to its clinical development team structure in preparation for late-stage clinical trials of lead candidate bemcentinib and increased activity in medical and scientific regulatory affairs.
Prof. Hani Gabra has transitioned from Chief Medical Officer to a part-time position as Director of Clinical Development, to focus on the scientific elements of clinical trial design and the important parallel translational research being undertaken by BerGenBio. Dr E. Gwyn Thomas has joined the Company as interim Head of Clinical Development.
Dr E. Gwyn Thomas is a physician specializing in medical oncology and clinical pharmacology and has over 25 years of experience in pharmaceutical medicine, drug development and medical affairs. Dr Thomas has held senior leadership roles at Wyeth Research, Genzyme Europe, Ibsen, Blue Earth Diagnostics and Mundipharma Research. During his career, Dr Thomas has successfully managed several New Drug Applications in the US, Japan and Singapore, as well as Marketing Authorisation Applications across Europe.
Richard Godfrey, Chief Executive Officer of BerGenBio commented “We are pleased to welcome Gwyn to BerGenBio. This is an exciting time for the Company as we continue to advance our lead candidate bemcentinib. With strong data obtained so far, Gwyn’s extensive experience will be crucial as we continue our dialogue with both EU and US regulators on the potential initiation of pivotal registration trials for this promising candidate.”
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About AXL
AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases.
In COVID-19, AXL has two synergistic mechanisms of action, it acts a co-receptor to ACE2, to which the spike protein of the SARS-CoV-2 virus attaches and enters the host cell, and AXL expression is upregulated in infected organs with an activation of the signalling pathway leading to suppression of the Type 1 Interferon immune response by infected cells and neighbouring cells, in their environment. Pre-clinical research studies demonstrate that bemcentinib inhibits SARS-CoV-2 host cell entry and promotes anti-viral Type I interferon response.
In cancer, increase in AXL expression has been linked to key mechanisms of drug resistance and immune escape by tumour cells, leading to aggressive metastatic cancers. AXL suppresses the body’s immune response to tumours and drives treatment failure across many cancers. High AXL expression defines a very poor prognosis subgroup in most cancers. AXL inhibitors, such as bemcentinib, therefore, have potential high value as monotherapy and as the cornerstone 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 including fibrosis.
About Bemcentinib
Bemcentinib (formerly known as BGB324), is a potential first-in-class, potent and highly selective AXL inhibitor, currently in a broad phase II clinical development programme. It is administered as an oral capsule and taken once per day. Ongoing clinical trials are investigating bemcentinib in COVID-19, and 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.
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 clinical development programme focused on combination and single agent therapy in 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 a companion diagnostic test to identify patient populations most likely to benefit from AXL inhibition: 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
Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com
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.