15 December 2023
BerGenBio ASA: BerGenBio announces closure of EU-SolidAct bemcentinib study arm in hospitalized COVID-19 patients
BERGEN, Norway, December 15, 2022 – BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, today announced that the Trial Steering Committee of the EU-SolidAct has recommended to discontinue the bemcentinib study arm in the Ph2b EU-SolidAct platform study in hospitalized COVID-19 patients due to a lack of eligible patients. This recommendation is supported by BerGenBio. The regulatory sponsor of the study, Oslo University Hospital, will enact this decision.
In April 2023, BerGenBio announced that the parties unanimously decided to pause the bemcentinib study arm due to a lack of eligible patients. The parties also agreed that a potential resumption of the study arm would be subject to eligible patients being available.
BerGenBio will not incur any financial impact from the closure of the bemcentinib study arm.
Martin Olin, BerGenBio’s Chief Executive Officer stated, “The changing nature of the COVID-19 pandemic makes further conduct of this study arm infeasible and we agree with the Trial Steering Committee’s decision. Our prior work in hospitalized COVID-19, including two Phase 2 studies, confirms that bemcentinib may reduce patient morbidity and mortality when severe respiratory infections are present. This extensive dataset gives us reassurance that further work in this area is warranted and we continue to evaluate the potential of bemcentinib in severe respiratory infections caused by other viral pathogens, including Respiratory Syncytial Virus (RSV) and influenza.”
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Contacts
Martin Olin CEO, BerGenBio ASA
ir@bergenbio.com
Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com
Investor Relations / Media Relations
Jan Lilleby
jl@lillebyfrisch.no
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 cancer and severe respiratory infections. The Company is focused on its proprietary lead candidate, bemcentinib, a potentially first-in-class selective AXL inhibitor in development for STK11 mutated NSCLC and severe respiratory infections.
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
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).
