BERGEN, Norway, Nov. 13, 2018
Phase II data in NSCLC with bemcentinib/KEYTRUDA combination: First stage of trial in previously treated patients reported 40% ORR and ca. 6 months median PFS in AXL positive patients, stage 2 actively enrolling patients
Additional NSCLC data: Bemcentinib/TARCEVA phase II combination trial in first line EGFRm patients reported that median PFS has surpassed that of TARCEVA monotherapy, encouraging efficacy reported in combination trial with docetaxel in later line patients
Pipeline update: IND filed for AXL antibody BGB149
BERGEN, Norway, Nov. 13, 2018 /PRNewswire/ -- BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, announces its results for the third quarter 2018. A presentation of the results by the Company's management will take place today at 10.00 am CET in Oslo – details below.
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We are pleased with the progress of our phase II clinical development programme with our selective AXL inhibitor bemcentinib, particularly in NSCLC. The observed correlation between patient response and positive AXL status in our combination trial with KEYTRUDA gives us confidence in bemcentinib's proposed mode of action and its broad appeal as a promising new agent treating aggressive cancer. The next six to nine months will be an exciting time for the company as we anticipate further clinical data from our phase II trials, particularly in NSCLC and acute myeloid leukaemia."
Highlights – Third Quarter & 2018
Bemcentinib/KEYTRUDA® combination in advanced non-small cell lung cancer (NSCLC) delivers highly promising phase II clinical results
Additional lung cancer phase II trials show promise for bemcentinib in combination with chemo- and targeted agents
Tissue- and blood-based biomarkers with potential for development as companion diagnostics
Arbitration process with Rigel Pharma Inc.
Anticipated data and news flow in the coming months
(Figures in brackets = same period 2017 unless otherwise stated)
Presentation and Webcast Details
A presentation by BerGenBio's senior management team will take place at 10.00 am CET at:
Hotel Continental, Stortingsgaten 24/26, 0117 Oslo
The presentation will webcast live and the link will be available at www.bergenbio.com in the section Investors/ Financial Reports. A recording will be available shortly after the webcast has finished.
The results report and the presentation will be available at www.bergenbio.com in the section: Investors/ Financial Reports from 7:00 am CET the same day.
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
International Media Relations
Citigate Dewe Rogerson
Media Relations in Norway
Jan Petter Stiff
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.
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The following files are available for download:
BGBIO 2018 3Q-report
BGBIO 2018 3Q-presentation