13 December 2021
BerGenBio ASA: BERGENBIO PRESENTS UPDATED BEMCENTINIB AML DATA AT ASH 2021 MEETING
Bergen, Norway, 13 December 2021- BerGenBio ASA (OSE:BGBIO), BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, is pleased to announce that it is presenting updated data from the Company’s Phase II study of bemcentinib (BCBC003) in a poster presentation today at the 63rd Annual American Society of Hematology (ASH) Meeting.
Professor Sonja Loges will provide an update from the Company’s Phase II study (BGBC003) of bemcentinib in combination with low dose cytarabine (LDAC) in older, relapsed and refractory AML patients unfit for intensive chemotherapy.
The data presented indicate that bemcentinib in combination with LDAC is well tolerated and offers meaningful clinical benefits. Translational research has identified immune-based activity associated with response to treatment, demonstrating that bemcentinib elicits activation of CD8+ T cells and B cells/plasma cells, two major adaptive immune cell populations responsible for anti-AML immune responses. Survival data measured as median Overall Survival (mOS) in older unfit relapsed AML patients looks encouraging compared to historical controls all through not yet matured.
Professor Sonja Loges, Chief Investigator of the BGBC003 trial commented: “The data on relapsed AML patients who currently have very few treatment options, is very encouraging. These results affirm our belief that the combination of bemcentinib and LDAC provides meaningful clinical benefits.”
Details of the presentation:
Title: Bemcentinib (Oral AXL Inhibitor) in combination with Low-dose Cytarabine Is Well Tolerated and Efficacious in Older Relapsed AML Patients. Updates from the Ongoing Phase II Trial (NCT02488408) and Preliminary Translational Results indicating Bemcentinib elicits anti-AML immune responses.
Session Name: 616. Acute Myeloid Leukemias: Investigational Therapies, Excluding Transplantation and Cellular Immunotherapies: Poster III
Time, Location: 6.00 – 8.00 PM Eastern, Georgia World Congress Center, Hall B5
-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
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.
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).
