BERGENBIO PRESENTING COVID-19 DATA IN LATE-BREAKING ABSTRACT PRESENTATION AT ECCMID 2021
Bergen, Norway, 29 June 2021 – BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical need, today announces that its late-breaking abstract, outlining Phase II clinical trial of bemcentinib, a first-in-class selective oral AXL inhibitor, in hospitalised COVID-19 patients has been published at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID), taking place online from 9-12 July 2021.
The abstract outlines data from two randomised, open-label Phase II studies in South Africa and India (BGBC020) and the UK (ACCORD2). 177 eligible patients were enrolled across 3 countries in both studies between May 2020 and March 2021 in bemcentinib and SOC arms. Results showed that from baseline to day 29, there were fewer deaths in the bemcentinib treated patients (2 of 58 and 1 of 28) versus SOC (3 of 57 and 5 of 32) for BGBC020 and ACCORD2 respectively. Bemcentinib was well tolerated throughout both studies.
These exploratory studies demonstrate encouraging evidence for the effect of bemcentinib in hospitalised COVID-19 patients receiving steroids ± remdesivir. Bemcentinib is an orally administered, well-tolerated AXL kinase inhibitor which targets a host receptor to achieve antiviral effects; this mechanism is unlikely to be attenuated by viral evolution.
Further analysis of the data will be shared in a presentation during the congress, details below. The presentation will also be made available on the Company website:
Presenting Author: Akil Jackson
Title: Bemcentinib, an oral AXL kinase inhibitor, results in lower mortality compared to standard of care (steroids ± remdesivir) in hospitalised patients with COVID-19
Session Name: LB: Interventions for improving COVID outcome
Session code: S191
Date: 12 July 2021
Time: 1:15 PM – 2:45 PM CEST
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.
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
Richard Godfrey CEO, BerGenBio ASA
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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
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