Regulatory Filings • Jan 27, 2022
Regulatory Filings
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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
Bergen/Oslo, Norway 27 January 2022- 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 withthe rapid and coordinated investigation of
medicationsto 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."
Contacts
For the EU-SolidAct:
Chief Investigator Marius Trøseid, Oslo University Hospital,
+4792440240,[email protected]
Trøseid is Senior consultant and Associate professor.
For BerGenBio:
Martin Olin, CEO, BerGenBio ASA
Rune Skeie, CFO, BerGenBio ASA
International Media Relations
Mary-Jane Elliott, Chris Welsh, Lucy Featherstone
Consilium Strategic Communications
+44 20 3709 5700
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). For more
information, visit? www.bergenbio.com
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. Suchrisks, 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.
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