12 December 2018
BerGenBio Presents Key Results from PhII Programme with Selective AXL Inhibitor Bemcentinib at DNB’s 9th Annual Nordic Healthcare Conference
- Bemcentinib proof of concept clinical data as monotherapy and in combination confirms focus on lung cancer & leukaemia
- AXL biomarker correlation supports bemcentinib’s proposed MoA, potential for Companion Diagnostic
- Significant milestones expected over next 12 months
Bergen, Norway, 12 Dec 2018 – BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company focused on developing a pipeline of first-in-class AXL kinase inhibitors to treat multiple cancer indications, announces that the Company will be presenting key results from its Phase II clinical programme with selective AXL inhibitor bemcentinib at the DNB’s 9th Annual Nordic Healthcare Conference in Oslo, Norway, today at 10:15-10:40 CET.
The slides are available for download at the Company’s website: www.bergenbio.com/investors/presentations/
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: “We have made significant progress during 2018 establishing clinical proof of concept for the remarkable utility of bemcentinib in cancers with high unmet clinical need and large market potential. We have shown that our once-a-day, oral selective AXL inhibitor is well tolerated as a monotherapy and in combination with immune-, targeted and chemotherapies. What is more, consistently we have seen that efficacy scales with AXL biomarker expression leading to superior response rates in AXL biomarker positive relapsed/refractory AML and MDS as a monotherapy as well as non-small cell lung cancer where we are combining with the immunotherapy blockbuster Keytruda. We have met all our operational milestones this year and are looking forward to starting a randomised phase II programme towards the end of H1 2019 based on key results obtained this year.”
About BerGenBio ASA
BerGenBio ASA is a clinical-stage biopharmaceutical company focused on developing a pipeline of first-in-class AXL kinase inhibitors to treat multiple cancer indications. 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, 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 in the second half of 2018.
AXL kinase is cell membrane receptor and an essential mediator of the biological mechanisms that drive aggressive and life-threatening diseases. In cancer, AXL drives tumour survival, treatment resistance and spread, as well as suppressing the body’s immune response to tumours. AXL expression has been established as a negative prognostic factor in many cancers. AXL inhibitors, therefore, have potential value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities.
BerGenBio is based in Bergen, Norway with a subsidiary in Oxford, UK. The company is listed on the Oslo Stock Exchange (ticker: BGBIO).
www.bergenbio.com
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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
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).
