28 July 2020
BerGenBio ASA: UPDATE ON BEMCENTINIB’S INVOLVEMENT IN POTENTIAL TREATMENT OF COVID-19 PANDEMIC
· Bergenbio in late stage set-up phase to sponsor and conduct a clinical study using bemcentinib in a country of high COVID-19 incidence
Bergen, Norway, 28[th] July 2020 – BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for unmet medical need, notes the UK Research and Innovation’s (UKRI) decision to cease the grant funding to the University Hospital Southampton NHS Trust for the COVID-19 ACCORD clinical study in which BerGenBio’s bemcentinib was the lead drug candidate to be tested. Subsequently the University Hospital Southampton NHS Trust, who is the study sponsor, has notified all sites in the ACCORD study to cease recruitment of new patients into the trial. Patients already recruited, including those dosed with bemcentinib, will continue on treatment as per the protocol.
Bergenbio also confirms it is in late stage set-up phase to sponsor and conduct a similar study to ACCORD in a country of high COVID-19 incidence and expects to be in a position to update the market in the near future.
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: “Bemcentinib still holds great potential for the treatment of COVID-19, hence its selection by the UK Government for its urgent inclusion as the first drug to be dosed in the ACCORD study. In recent weeks the incidence of COVID-19 in the UK has drastically reduced and as a result the ACCORD programme hasn’t moved forward as swiftly as we expected. We are faced with the reality of the pandemic and need to adapt quickly in order to move forward in the interests of patients.
“We look forward to sponsoring an oversees study and are pleased that we are well positioned to do this important and rapid testing.”
The ACcelerating COVID-19 Research & Development platform (ACCORD) study was being funded by the Department of Health and Social Care (DHSC) and UK Research and Innovation (UKRI) to rapidly test potential drugs through early stage clinical trials and feed them into the UK’s large-scale COVID-19 studies such as the RECOVERY trial (https://www.nihr.ac.uk/urgent-public-health-research-studies-for-covid-19/randomised-evaluation-of-covid-19-therapy-recovery/24513), currently the world’s largest randomised controlled clinical trial for COVID-19 treatment.
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. 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 and leukaemia. 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: 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
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).
