Regulatory Filings • Jan 15, 2020
Regulatory Filings
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BERGENBIO MEETS EFFICACY ENDPOINT for FIRST STAGE OF PHASE II TRIAL WITH AXL INHIBITOR BEMCENTINIB IN COMBINATION WITH KEYTRUDA[®] IN NSCLC PATIENTS PROGRESSING ON IMMUNE CHECKPOINT INHIBITORS
· First stage clinical efficacy endpoint met for the Phase II trial cohort
evaluating selective AXL inhibitor bemcentinib in combination with Keytruda[®]
in patients with advanced NSCLC who have failed checkpoint inhibitor therapy.
· Criteria were met for expansion of this cohort to a second stage.
Bergen, Norway, 15 January 2019 - BerGenBio ASA (OSE: BGBIO) a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
multiple cancer indications, announces meeting the clinical efficacy endpoint of
stage 1 of Cohort B in the phase II trial (BGBC008) evaluating bemcentinib in
combination with MSD's Keytruda[®] (pembrolizumab) in previously treated non
-small cell lung cancer (NSCLC) patients with confirmed progression on prior
immune checkpoint therapy. The trial will advance into the second stage.
The company reports that the Cohort B, stage 1 efficacy analysis has met the
confirmed response of one or more patients therefore continuation to stage two
evaluation is planned.
The second stage will enroll a further 16 patients to confirm the safety and
clinical efficacy of the combination in NSCLC patients that have confirmed
progression on prior immune checkpoint therapy.
Comprehensive exploratory biomarker studies of tumor and blood samples are
ongoing to measure of AXL expression and immune modulation. Further results from
the trial are expected during 2020 and will be presented at appropriate
scientific conferences.
The BGBC008 trial (ClinicalTrials.gov Identifier: NCT03184571) is being
sponsored by BerGenBio. MSD, a tradename of Merck & Co., Inc., Kenilworth, New
Jersey, USA, will continue to supply Keytruda[®] for use in the study under a
collaboration agreement signed in March 2017.
Richard Godfrey, Chief Executive Officer of BerGenBio, said: "Reversing
resistance to immune checkpoint inhibitors in patients who have relapsed on
immunotherapy is a highly desirable alternative to the second-line chemotherapy
standard-of-care. We are very excited with these early results in this
challenging setting and look forward to expanding the study to confirm these
findings and reporting comprehensive translational insight. Furthermore, Cohort
C in NSCLC patients having failed 1L chemo-checkpoint inhibitor combination is
now recruiting, and top line data should be available in the coming months."
- END -
About AXL
AXL kinase is a cell membrane receptor and an essential mediator of the
biological mechanisms underlying life-threatening diseases. In cancer, AXL
suppresses the body's immune response to tumours and drives cancer treatment
failure across many indications. AXL inhibitors, therefore, have potential high
value at the centre of cancer combination therapy, addressing significant unmet
medical needs and multiple high-value market opportunities. Research has also
shown that AXL mediates other aggressive diseases.
About Bemcentinib
Bemcentinib (formerly known as BGB324), 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. Bemcentinib targets and binds to the intracellular catalytic
kinase domain of AXL receptor tyrosine kinase and inhibits its activity.
Increase in AXL function has been linked to key mechanisms of drug resistance
and immune escape by tumour cells, leading to aggressive metastatic cancers.
About BerGenBio ASA
BerGenBio is a clinical-stage biopharmaceutical company focused on developing
transformative drugs targeting AXL as a potential cornerstone of therapy for
aggressive diseases, including immune-evasive, drug resistant cancers. The
company's proprietary lead candidate, bemcentinib, is a potentially first-in
-class selective AXL inhibitor in a broad Phase II oncology clinical development
programme focused on combination and single agent therapy in lung cancer and
leukaemia. A first-in-class functional blocking anti-AXL antibody is undergoing
Phase I clinical testing. In parallel, BerGenBio is developing a companion
diagnostic test to identify those patient populations most likely to benefit
from bemcentinib: this is expected to facilitate more efficient registration
trials supporting 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). For more
information, visit www.bergenbio.com
Contacts
Richard Godfrey CEO, BerGenBio ASA
+47 917 86 304
Rune Skeie, CFO, BerGenBio ASA
+47 917 86 513
International Media Relations
Mary-Jane Elliott, Chris Welsh, Nicholas Brown, Lucy Featherstone, Carina
Jurs Consilium Strategic Communications
+44 20 3709 5700
Media Relations in Norway
Jan Petter Stiff, Crux Advisers
+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.
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