27 September 2022
BerGenBio ASA: BERGENBIO ANNOUCES FIRST PATIENT RANDOMIZED IN BEMCENTINIB TRIAL IN EU-SOLIDACT PLATFORM FOR HOSPITALIZED COVID-19 PATIENTS
BERGEN, Norway, September 27, 2022 – BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharma-ceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, and Oslo University Hospital announced today that the first patient has been included in a study of BerGenBio’s oral, highly selective AXL inhibitor, bemcentinib, as part of the EU-SolidAct trial in hospitalized 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 designed to investigate treatment options for hospitalized patients with COVID-19 and emerging infectious diseases.
Bemcentinib was selected by an international group of experts to be studied in the EU-SolidAct platform in up to 500 hospitalized COVID-19 patients in a Phase 2b, multi-center, randomized, placebo-controlled trial.
Martin Olin, Chief Executive Officer of BerGenBio, commented: “COVID-19 infections and hospital admissions continues to evolve with new variants and the expected fall/winter season impact. There is a need to identify new effective therapies for hospitalized patients and bemcentinib represents a promising treatment modality for this patient population through its unique mechanism of action, blocking viral entry, stimulating the innate immune system and promoting lung tissue repair. Importantly, bemcentinib enhances the Type I interferon response, causing these cytokines to activate immune cells to fight the infection regardless of spike protein or mutation. Based on the results of our Phase 2a studies and learnings throughout the pandemic, we are eager to further study the effectiveness of bemcentinib in COVID-19 and are delighted to now have randomized the first patient in the EU-SolidAct platform.”
The EU-SolidAct platform trial includes 68 clinical sites in 8 countries and 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).
Professor Marius Trøseid, Oslo University Hospital, Chief Investigator of the EU-SolidAct trial, commented: “As new subvariants continue to evolve, it is critical to have greater treatment options in order to reduce hospital stays and halt disease progression. We’re pleased to be partnering with BerGenBio in the initiation of this trial, as we look to enroll up to 500 hospitalized COVID-19 patients.”
Contacts
For the EU-SolidAct:
Marius Trøseid, Chief Investigator of the EU-SolidAct trial, Senior Consultant and Professor, Oslo University Hospital
+4792440240,marius.troseid@medisin.uio.no
For BerGenBio:
Martin Olin CEO, BerGenBio ASA
ir@bergenbio.com
Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com
Investor Relations / Media Relations
Graham Morrell
Graham.morrell@bergenbio.com
+1 781 686 9600
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 COVID-19.
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 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).
