18 May 2018
BerGenBio to present interim clinical and biomarker data with selective AXL inhibitor bemcentinib in AML and MDS at EHA
Bergen, Norway, 18 May 2018 – BerGenBio ASA (OSE:BGBIO) announces that the company and its collaborators will present interim clinical data from its Phase II clinical development programme with bemcentinib, a selective, oral AXL inhibitor, in acute myeloid leukaemia (AML) and myeloid dysplastic syndrome (MDS) at the 23rd Congress of the European Hematology Association (EHA) in Stockholm (14-17 June 2018).
Abstracts are now available online at https://ehaweb.org and details of the presentations are below. The posters presented at EHA will be made available on www.bergenbio.com in the Investors / Presentations section following the sessions.
Presentations at EHA
Saturday 16 June, 5:30 – 7:00 PM CEST
Ph II trial with selective oral AXL inhibitor bemcentinib (BGB324) in relapsed/refractory AML and MDS: Identification of predictive and pharmacodynamic biomarker candidates associated with pt benefit
- Sonja Loges, MD, PhD et al
- Session: Acute myeloid leukemia – Clinical
- Abstract code: PS981
Single cell signaling pharmacodynamics and clonal evolution in a phase I/II clinical trial of selective AXL inhibitor bemcentinib (BGB324) in R/R acute myeloid leukemia and myelodysplastic syndrome
- Monica Hellesøy, PhD et al
- Session: Acute myeloid leukemia – Biology & Translational Research
- Abstract code: PS965
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About BerGenBio ASA
BerGenBio ASA is a clinical-stage biopharmaceutical company focused on developing a pipeline of first-in-class AXL kinase inhibitors as a potential cornerstone of combination cancer therapy. The Company is a world leader in understanding the essential role of AXL kinase in mediating cancer spread, immune evasion and drug resistance in multiple aggressive solid and haematological cancers.
BerGenBio’s lead product, bemcentinib (BGB324), is a selective, potent and orally bio-available small molecule AXL inhibitor in four Company sponsored Phase II clinical trials in major cancer indications, with read-outs anticipated during 2018. It is the only selective AXL inhibitor in clinical development.
The Company sponsored clinical trials are:
- Bemcentinib with TARCEVA® (erlotinib) in advanced EGFR mutation driven non-small cell lung cancer (NSCLC)
- Bemcentinib with KEYTRUDA in advanced adenocarcinoma of the lung, and
- Bemcentinib with KEYTRUDA in triple-negative breast cancer (TNBC).
- Bemcentinib as a single agent and combination therapy in acute myeloid leukaemia (AML) / myeloid dysplastic syndrome (MDS)
The clinical trials combining bemcentinib with KEYTRUDA in adenocarcinoma of the lung and TNBC are conducted in collaboration with Merck & Co., Inc. (Kenilworth, NJ, USA), through a subsidiary.
In addition, a number of investigator-sponsored trials are underway, including a trial to investigate bemcentinib with either MEKINIST® (trametinib) plus TAFINLAR® (dabrafenib) or KEYTRUDA in advanced melanoma, as well as a trial combining bemcentinib with docetaxel in advanced NSCLC.
BerGenBio is simultaneously developing a companion diagnostic test to identify patient subpopulations most likely to benefit from treatment with bemcentinib. This will facilitate more efficient registration trials and support a precision medicine based commercialization strategy.
The Company is also developing a diversified pre-clinical pipeline of drug candidates, including BGB149, an anti-AXL monoclonal antibody.
For further information, please visit: www.bergenbio.com
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, TARCEVA® is a registered trademark of OSI Pharmaceuticals, LLC., marketed by Roche-Genentech. TAFLINAR® is a registered trademark of Novartis International AG and MEKINIST® is a registered trademark of GSK plc.
Contacts
Richard Godfrey
CEO, BerGenBio ASA
+47 917 86 304
Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com
+47 917 86 513
Media Relations in Norway
Jan Petter Stiff, Crux Advisers
stiff@crux.no
+47 995 13 891
International Media Relations
David Dible, Mark Swallow, Marine Perrier, Citigate Dewe Rogerson
bergenbio@citigatedewerogerson.com
+44 207 638 9571
This information is subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.
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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).
