2 June 2020
BerGenBio ASA: BERGENBIO CONFIRMS FIRST COVID19 PATIENT DOSED WITH BEMCENTINIB IN ACCORD TRIAL
Bergen, Norway – 02 June 2020: BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical need, today announces that dosing has commenced in the UK Government-backed Phase II clinical trial assessing bemcentinib in hospitalised COVID-19 patients.
Bemcentinib was selected as the first candidate to be tested as part of the ACcelerating COVID-19 Research & Development platform (ACCORD) study, launched by the Department of Health and Social Care (DHSC) and UK Research and Innovation (UKRI) on 28[th] April 2020. ACCORD brings together a single, UK-wide clinical trial platform to rapidly test potential drugs through early stage clinical trials and feed them into the UK’s large-scale COVID-19 studies.
The first patient has been dosed with bemcentinib at the University Hospital Southampton NHS Foundation Trust. The study is open in a further seven sites across the UK. The Phase II study will recruit 120 subjects in total, assessing the safety and efficacy of bemcentinib as an add-on therapy to standard of care (SoC) in 60 hospitalised COVID-19 patients with a further 60 control group patients receiving SoC.
BerGenBio anticipates that top line data will readout later in the summer. Data will be open source and freely available to enable global knowledge sharing and collaboration. If positive results are seen, bemcentinib will advance rapidly into the large-scale Phase III trials in the UK.
The study is fully funded by the DHSC and UKRI and is being managed by clinical research company IQVIA. Drug material and other trial resources will be provided by BerGenBio.
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: “We are delighted that dosing has commenced with bemcentinib in the ground-breaking ACCORD study and we hope that patients will swiftly start to see benefits. Initiating this clinical trial in such short order is the result of tremendous teamwork between my colleagues at BerGenBio and the teams at IQVIA and UHS, among many others. This illustrates exactly what can be achieved when we all work together and focus on delivering the best experimental drug candidates to patients that so urgently need them. We look forward to providing results as soon as is practically possible and very much hope our drug can fulfil the aims of the study and be used to treat thousands of COVID-19 patients worldwide.”
Professor Tom Wilkinson, ACCORD clinical academic lead based at the National
Institute for Health Research (NIHR) Southampton Biomedical Research Centre, said: “The ACCORD platform is allowing us to rapidly test potential new treatments in response to the COVID-19 emergency. This unique national platform for developing COVID-19 drug candidates will access the world-class expertise and resources of the NIHR Respiratory Translational Research Collaboration and allied centres nationwide. We believe this programme will be key to developing effective new treatments and are delighted to see the first candidate, bemcentinib, enter the clinic today.”
About BerGenBio
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 and COVID-19 infections. 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 those patient populations most likely to benefit from bemcentinib or tilvestamab: this is expected to facilitate more efficient registration trials and support 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
For more information, please contact
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 7780 600290
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.
About Oncoinvent
Oncoinvent is developing Radspherin®, a receptor-independent alpha radiation therapy that leverages the unique anatomy of the abdominal cavity to destroy residual micrometastases using a single, highly localized dose of alpha radiation. The initial clinical focus is treatment of ovarian and colorectal cancer patients after surgical removal of the primary tumor and visible metastases in the peritoneum, the thin membrane lining the abdominal cavity and covering the abdominal organs.
This radiopharmaceutical is designed to prevent or delay recurrence in the peritoneal cavity, keeping patients disease-free for longer than the current standard of care and thereby also impacting overall survival. It is broadly applicable to any cancer that spreads to the peritoneum, e.g. ovarian, colorectal, and gastric cancers. Radspherin® stands out for its simplicity, excellent safety profile, and seamless integration into existing surgical workflows. Oncoinvent’s product is easy to use, avoids systemic delivery and significant toxicity. It is also differentiated in being simple to manufacture, scalable, and supply de-risked.
Data from two trials in ovarian (phase 1) and colorectal (phase 1/2a) cancers, are highly promising, showing an excellent safety profile and meaningful signals of efficacy. Interim data from an ongoing, randomized, controlled phase 2 ovarian cancer trial is expected in 2026. With cost-effective manufacturing, blockbuster potential, active pharma partnership momentum, plus strong endorsements from leading experts, Oncoinvent is built for scale and commercial success, and is set to become the new standard for post-surgical cancer care. The Company was founded by the originators of Algeta and Xofigo (acquired by Bayer).
