7 January 2025
BerGenBio ASA: BerGenBio Announces First Patient Entered Into Advanced Adenocarcinoma Lung Cancer Trial
Bergen, Norway, January 7, 2025 – BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing the novel, selective AXL kinase inhibitor bemcentinib for lung cancer announced today that the first patient has been included in a clinical trial sponsored by the Mays Cancer Center at The University of Texas Health Science Center at San Antonio (UT Health San Antonio). The study is led by Josephine A. Taverna, MD, a thoracic oncologist at the Mays Cancer Center and Associate Professor in the Division of Hematology and Oncology at UT Health San Antonio.
“Dr. Taverna’s research has shown that AXL and JAK-STAT3 work in tandem to transmit signals promoting tumor growth and metastasis in advanced lung cancer. We are pleased to see this research advancing into clinical application and believe this study aligns closely with BerGenBio’s strategic focus on addressing the significant unmet needs of lung cancer patients, including first-line Non-Small Cell Lung Cancer patients with mutations in the STK11 gene”, said Olav Hellebø, Chief Executive Officer of BerGenBio.
The trial is designed to study BerGenBio’s bemcentinib in combination with pacritinib, which is a JAK2 inhibitor indicated for treatment of the bone marrow disorder myelofibrosis in patients with platelet counts below 50 x 109/L. It works by blocking certain growth factors and cytokines. Pacritinib is marketed in the United States as VONJO® and owned by Swedish Orphan Biovitrum AB (Sobi®) (STO:SOBI), a specialized international biopharmaceutical company. Bemcentinib is a first-in-class, selective, oral once-a-day inhibitor of AXL receptor tyrosine kinase, a promising therapeutic target for serious diseases.
The study will include patients with lung adenocarcinoma, the most common type of lung cancer in the United States, accounting for approximately 40% of all lung cancers. The study is funded by a grant from the National Cancer Institute (NCI) of the National Institutes of Health (NIH).
Contacts
Olav Hellebø, CEO, BerGenBio ASA
Rune Skeie, CFO, BerGenBio ASA
About the Trial (NCT 06516887)
The trial sponsored by the Mays Cancer Center at The University of Texas Health Science Center at San Antonio is entitled “Study of Bemcentinib plus Pacritinib in Patients with Advanced adenocarcinoma” is a Phase Ib/II, open-label, single institution dose-escalation, safety, pharmacokinetics, pharmacodynamic and efficacy study. It is anticipated that a total of 44 patients will be enrolled in the trial. In the PhIb portion varying doses of bemcentinib and pacritinib will be studied in combination to determine safety, tolerability and the maximum tolerated dose. The Phase II portion of the trial will study the dose(s) selected in Phase Ib and will assess the overall response rate and progression free survival of treated 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 cancer. The Company is focused on its proprietary lead candidate, bemcentinib, a potentially first-in-class selective AXL inhibitor in development for STK11 mutated NSCLC. 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).
