9 October 2018
BerGenBio to present interim phase II clinical, preclinical and biomarker data with selective AXL inhibitor bemcentinib at ESMO
Bergen, Norway, 9 October 2018 – BerGenBio ASA (OSE:BGBIO) announces that the company and its collaborators will present interim clinical and biomarker data from its Phase II clinical programme with bemcentinib (BGB324), a first-in-class highly selective oral AXL inhibitor at the ESMO 2018 Congress in Munich (19 – 23 October 2018).
Pre-clinical data on the role of AXL inhibition in Myelodysplastic Syndrome (MDS) will also be presented. Details of the presentations are below.
The posters will be made available at www.bergenbio.com in the Investors / Presentations section at the time of presentation and full abstracts will be made available online according to ESMO’s embargo schedule: https://www.esmo.org/Conferences/ESMO-2018-Congress/Abstracts
Poster presentations at ESMO:
Sunday 21 October, 11:15 – 12:15, Hall B3 – Room 21
Predictive and Pharmacodynamic Biomarkers Associated with Phase II, selective and orally bioavailable AXL Inhibitor Bemcentinib Across Multiple Clinical Trials
- Robert Holt, PhD et al
- Poster Discussion session – Translational research 2
- Invited discussant: 11:15 – 11:45
- Presentation number: 63PD
Sunday 21 October, 12:45 – 13:45, Hall A3 – Poster Area
Update on the randomised Phase Ib/II study of the selective small molecule AXL inhibitor bemcentinib (BGB324) in combination with either dabrafenib/trametinib or pembrolizumab in patients with metastatic melanoma
- Cornelia Schuster, MD, PhD et al
- Poster display session – Melanoma and other skin tumours
- Presentation number: 1266P
Sunday 21 October, 16:30 – 17:45, Hall B3 – Room 21
The identification of the AXL/Gas6 signalling axis as a key player of myelodysplastic syndrome (MDS) and the potential of the oral selective AXL inhibitor bemcentinib in the treatment of MDS
- Hind Medyouf, PhD et al
- Poster Discussion session – Haematological malignancies
- Invited discussant: 16:30 – 16:55
- Presentation number: 1009PD
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About the ESMO Congress
The ESMO Congress is the leading European meeting for medical oncology convening over 20,000 international delegates from the field. ESMO 2018 will be held in Munich, Germany 19- 23 October 2018.
About BerGenBio’s Companion Diagnostics programme
In parallel with its phase II clinical trial programme, BerGenBio explores predictive biomarker candidates with the aim to develop a companion diagnostic to identify patients most likely to benefit from bemcentinib treatment.
Thus far, the company reported strong correlation with response of both plasma soluble AXL levels and the presence of tissue AXL in relapsed/refractory AML or MDS and advanced NSCLC, respectively.
About the BGBIL006 trial
Melanoma is the most serious type of skin cancer as it may spread to lymph nodes and distant organs if not discovered in time. Melanoma occurs when the cells that colour the skin, the so-called melanocytes, start to divide uncontrollably.
The BGBIL006 trial is a randomised Phase 1b/2 investigator sponsored clinical study of bemcentinib (BGB324) in combination with either the MAPK inhibitors MEKINIST® (trametinib) plus TAFINLAR® (dabrafenib) or the immune checkpoint inhibitor KEYTRUDA® (pembrolizumab) in patients with advanced melanoma.
For more information please access trial NCT02872259at www.clinicaltrials.gov.
About BerGenBio ASA
BerGenBio is a clinical-stage biopharmaceutical company focused on developing transformative drugs targeting AXL as a potential cornerstone of therapy for advanced and aggressive 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. Ongoing clinical trials are investigating bemcentinib in multiple solid and haematological tumours, in combination with current and emerging therapies (including immunotherapies, targeted therapies and chemotherapy), and as a single agent.
In parallel, BerGenBio is developing a companion diagnostics test to identify patient populations most likely to benefit from bemcentinib: this is expected to facilitate more efficient registration trials and support a precision medicine-based commercialisation strategy.
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
About AXL
AXL kinase is a 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.
Contacts
Richard Godfrey
CEO, BerGenBio ASA
+47 917 86 304
Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com
+47 917 86 513
International Media Relations
David Dible, Mark Swallow, Marine Perrier, Citigate Dewe Rogerson
bergenbio@citigatedewerogerson.com
+44 207 638 9571
Media Relations in Norway
Jan Petter Stiff, Crux Advisers
stiff@crux.no
+47 995 13 891
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).
