2 November 2018
BerGenBio to present late-breaking abstract on Phase II trial of bemcentinib in combination with KEYTRUDA® in advanced NSCLC at SITC
- Combination of selective AXL inhibitor bemcentinib and KEYTRUDA® featured in late breaking abstract at leading IO conference SITC
- Analysis comprises stage 1 (n=24) in PhII trial in 2L advanced NSCLC
- Stage 2 open and enrolling
Bergen, Norway, 2 November 2018 – BerGenBio ASA (OSE:BGBIO) announces that the analysis of the first stage of its Phase II clinical trial with bemcentinib, a first-in-class selective oral AXL inhibitor, in combination with the anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with previously treated, advanced non-small cell lung cancer (NSCLC) has been selected as a Late-breaking Abstract at the annual Society for Immunotherapy in Cancer (SITC) 2018 congress in Washington D.C. (7-10 November 2018).
Late-breaking abstracts highlight novel and potentially practice-changing studies, and their acceptance for presentation is subject to favourable assessment by a panel of clinical and scientific experts. In total, only 21 abstracts were accepted in the late-breaking category at this year’s SITC congress: https://sitc.sitcancer.org/2018/abstracts/titles/late-breaking/
An update from BerGenBio’s biomarker and companion diagnostic programme will also be presented as a poster within the regular abstract section. See details below.
Presentations at SITC: Friday 9 November, 12:45 – 2:15 p.m. and 6:30 – 8
p.m. EST, Hall E
A Phase II study of bemcentinib (BGB324), a first-in-class selective AXL
inhibitor, in combination with pembrolizumab in patients with advanced
NSCLC: Analysis of the first stage
- Matthew Krebs, PhD et al
- Category: 33rd Annual Meeting Late-Breaking Abstracts
- Presentation number: P715
Predictive and pharmacodynamic biomarkers associated with treatment with
the oral selective AXL Inhibitor bemcentinib in combination with
pembrolizumab in patients with advanced NSCLC and Melanoma
- Robert Holt, PhD, et al
- Category: Biomarkers and Immune Monitoring
- Presentation number: P115
The full abstracts will be published on November 6th at 8 a.m. Eastern time at https://www.sitcancer.org/2018/home.
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About SITC
The Society for Immunotherapy of Cancer (SITC) is the world’s leading member-driven organisation specifically dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy. Over 4,000 delegates are expected to attend the SITC 33rd Annual Congress in Washington D.C. on Nov 7-10 2018. For more information please see www.sitcancer.org
About the BGBC008 trial: A Phase II study of bemcentinib in combination with pembrolizumab in patients with previously treated advanced NSCLC
The BGBC008 trial is a phase II multi-centre open-label study of bemcentinib in combination with KEYTRUDA (pembrolizumab) in previously treated, immunotherapy naïve, patients with advanced adenocarcinoma of the lung, the most common form of non-small cell lung cancer (NSCLC). The objective of the trial is to determine the anti-tumour activity of this novel drug combination. Responses will be correlated with biomarker status (including AXL kinase and PD-L1 expression).
For more information please access trial NCT03184571 at www.clinicaltrials.gov.
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.
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
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).
