BerGenBio ASA: BerGenBio announces Nature Communications Publication of BGBC003 Ph2 data in relapsed/refractory Acute Myeloid Leukemia patients
The article identifies promising survival results in relapsed/refractory AML patients
warranting further study
Bergen, Norway – 26 March 2025 – BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL inhibitors for severe unmet medical needs, today announces the publication of a peer-reviewed article entitled “Bemcentinib as Monotherapy and in Combination with Low-Dose Cytarabine in Acute Myeloid Leukemia Patients Unfit for Intensive Chemotherapy” in the journal Nature Communications.
This article is accessible here: www.nature.com/articles/s41467-025-58179-6.pdf
The article highlights results in 36 patients treated with a combination of BerGenBio’s selective oral AXL inhibitor bemcentinib in combination with low-dose cytarabine (LDAC) chemotherapy. Overall, patients who received the combination had an overall survival of 7.8 months, substantially longer than that expected in this difficult-to-treat patient population.
The lead investigator of the study, Professor Sonja Loges, MD, PhD. of the German Cancer Research Center (DKFZ), Heidelberg, Germany stated, “Following first line treatment of AML, most patients will relapse, and beyond first line the prognosis of older patients with relapsed or refractory AML, the population studied in BGBC003 is particularly poor. With other treatment approaches, the current overall survival of R/R AML patients is believed to be approximately 2.9-4 months. The authors of this article believe that the BGBC003 results in this population warrant further study.”
Olav Hellebo, CEO of BerGenBio commented “Our BGBC003 study evaluated bemcentinib in relapsed/refractory (R/R) AML patients who have limited effective treatment options today. The presence of AXL is a poor prognostic factor in this population and AXL is believed to promote chemotherapy resistance and decreased antitumor immune response. We believe, as a highly selective AXL inhibitor, bemcentinib holds promise as a treatment for these patients with extremely high unmet medical needs.”
Contacts
Olav Hellebo, BerGenBio ASA
Rune Skeie, CFO, BerGenBio ASA
Investor Relations / Media Relations
Jan Lilleby
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. 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).