BERGEN, Norway, Jan. 15, 2020 /PRNewswire/ -- 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."
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
rune.skeie@bergenbio.com
+47-917-86-513
International Media Relations
Mary-Jane Elliott, Chris Welsh, Nicholas
Brown, Lucy Featherstone,
Carina Jurs Consilium Strategic Communications
bergenbio@consilium-comms.com
+44-20-3709-5700
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.
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SOURCE BerGenBio ASA