25 April 2022
BerGenBio ASA: BERGENBIO PRESENTS BEMCENTINIB COVID-19 CLINICAL TRIAL DATA AT ECCMID 2022
Bergen, Norway, 25 April 2022 – BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL inhibitors for severe unmet medical needs, announces that it is presenting data today from its Phase IIa bemcentinib COVID-19 clinical trial (BCBC020) in a poster presentation at the 32nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), being held both online and in-person in Lisbon, Portugal, from April 23-26, 2022.
The poster presentation will share findings from the Company’s Phase IIa open label study of 115 patients evaluating bemcentinib in combination with Standard of Care (SoC) compared to a SoC control arm in the treatment of moderate to severe COVID-19 patients, immediatelyafter hospital admission (BGBC020).
Clinical data from the study show that bemcentinibtreatment (up to 14 days) confers early and sustained protection, limiting clinical deterioration in patients. Bemcentinib treated patients were discharged earlier from the hospital, required less supplementary oxygen and demonstrated a significant reduction in the need for intubation or ventilation.
Biomarker analysis demonstrates that treatment with bemcentinibreduced markers of acute inflammation and profibrotic cytokines, and increased expression of protective factors. These changes were more pronounced in patients with more serious disease, determined by high C-Reactive Protein (CRP) rates, high neutrophil to lymphocyte ratio (N/L) ratio or increased oxygen usage.
Preclinical data is also being presented from in vitro studies in lung epithelial cells on bemcentinib’s activity on variants of concern. These data suggest that bemcentinib inhibits infection of multiple SARS-CoV-2 variants, including Omicron, building on previous preclinical research from the Company.
Martin Olin, CEO of BerGenBio, commented: “The data we are presenting at ECCMID today further demonstrates the effectiveness of bemcentinib as a treatment for severe respiratory infections such as COVID-19. We have been pleased to see bemcentinib’s impact on reducing disease deterioration in patients. In addition, we’re encouraged to see that bemcentinib exerts a broad anti-inflammatory and pro-repair effect on blood biomarkers. We look forward to the initiation of the EUSolidAct platform trial which will further assess bemcentinib in hospitalised COVID-19 patients.”
Details of today’s poster presentation are as follows:
Abstract: 04778: Bemcentinib modulation of inflammatory, fibrotic and tissue repair pathways correspond with favourable clinical outcomes in hospitalised COVID-19 patients demonstrating higher severity cues: a biomarker perspective
Session Name: 12c. Clinical features, case management, outcome (incl long-term): programme no. L0383
Time, Location: Monday, 25th April 2022, 12:00pm – 13:00pm (WEST)
-End-
Contacts:
Martin Olin CEO, BerGenBio ASA
ir@bergenbio.com
Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com
International Media Relations
Mary-Jane Elliott, Chris Welsh, Lucy Featherstone
Consilium Strategic Communications
bergenbio@consilium-comms.com
+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.
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. 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).
