BerGenBio and Oslo University Hospital Announce the AXL Inhibitor Bemcentinib will be Studied in the EU Funded EU-SolidAct trial in Hospitalised COVID-19 Patients

BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL inhibitors for severe unmet medical needs and Oslo University Hospital announced today the execution of a collaborative agreement to study the BerGenBio AXL inhibitor bemcentinib, in hospitalised COVID-19 patients.

The EU-SolidAct trial - European DisCoVeRy for Solidarity: An Adaptive Pandemic and Emerging Infection Platform Trial - is part of EU-RESPONSE, a pan-European research project involved with the rapid and coordinated investigation of medications to treat COVID-19 during the ongoing pandemic. The EU-SolidAct (EudraCT: 2021-000541-41; clinicaltrials.gov ID NCT04891133) is a multi-center, randomized, adaptive Phase 2 and 3 platform trial, the master protocol of which has been developed to evaluate potential treatments in hospitalised patients with COVID-19, the disease caused by the SARS-CoV2 virus (coronavirus). Under the trial, bemcentinib will be studied in up to 500 hospitalised COVID-19 patients. In support of the trial, BerGenBio will provide bemcentinib drug material and incremental funding of costs related to the bemcentinib sub-protocol. 

The first drug studied under the EU-SolidAct platform was baricitinib, marketed by Eli Lilly and Company, and is now under market authorisation evaluation by the EMA (European Medicines Agency) for use in hospitalised COVID-19 patients.  BerGenBio's AXL inhibitor, bemcentinib, has been selected by an international expert group to be the second compound to be studied in the EU-SolidAct platform.

EU-SolidAct has established clinical sites in 15 countries. The trial is sponsored by Oslo University Hospital, Norway in collaboration with the Institut National de la Santé Et de la Recherche Médicale (Inserm), France and the not-for-profit intergovernmental organization European Clinical Research Infrastructure Network (ECRIN). The trial through the EU-RESPONSE project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 101015736. Individual patient-level data will be made as public as possible while maintaining the integrity and privacy of the trial participants.

Martin Olin, Chief Executive Officer of BerGenBio, commented: "As the COVID-19 pandemic continues to evolve, it is even more important to identify new therapies for hospitalised patients that have a mechanism of action effective across disease variants. The EU-SolidAct platform provides BerGenBio with a unique opportunity to rapidly study the effectiveness of bemcentinib and to evaluate the promising signals of efficacy that were observed in the hospitalised patients requiring oxygen in earlier studies."

Associate professor Marius Trøseid, Oslo University Hospital, Chief Investigator of EU-SolidAct, commented: "With new variants and evolving patient populations, it is increasingly important to have more treatment options for preventing need of intensive care and long hospitalisations. We hope that bemcentinib will help reduce disease severity and improve the clinical condition of hospitalized patients."

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 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 potentially 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). 

About Oslo University Hospital

Oslo University Hospital is a highly specialized hospital in charge of extensive national, regional and local hospital assignments. As Scandinavia's largest hospital, we carry out more than 1.2 million patient treatments each year. Oslo University Hospital is responsible for approximately 50 percent of all medical and health care research conducted at Norwegian hospitals. We have a leading role in the development of research and innovation, as well as the development of tomorrow's healthcare, precision medicine and treatment.

About Inserm

Founded in 1964, Inserm is a public science and technology institute. It is dedicated to biomedical research and human health and is involved every step of the way from the research laboratory to patient care. It is one of the most prestigious institutions in the world that is committed to scientific challenges and progress in these fields. Inserm brings together more than 15,000 researchers, engineers, technicians and administrative staff to improve the health of all. www.inserm.fr/en/

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 considered to be inside information pursuant to the EU Market Abuse Regulation and is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

SOURCE BerGenBio ASA