BERGEN, Norway, Nov. 3, 2018 /PRNewswire/ --
- 43% CR/CRi/CRp rate with bemcentinib monotherapy reported in
AXL biomarker positive R/R AML/MDS patients (6 out of 14)
- Phase II trial continues in combination with
chemotherapeutics in first line AML
- Bemcentinib with decitabine cohort has completed
recruitment, data will be submitted for presentation at upcoming
medical congress
BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical
company focused on developing a pipeline of first-in-class AXL
kinase inhibitors to treat multiple cancer indications, today
announced that it presented a comprehensive analysis of monotherapy
data from its BGBC003 clinical trial (NCT02488408) with selective
AXL inhibitor bemcentinib in patients with relapsed/refractory
Acute Myeloid Leukaemia (AML) or high-risk Myelodysplastic Syndrome
(MDS).
In a poster presentation at the 60th American Society of
Hematology Annual Meeting (ASH) in San
Diego entitled: "Comprehensive Analysis of the Dose
Escalation, Expansion and Correlates in the Ph I/II Trial BGBC003
with the Selective Oral AXL Inhibitor Bemcentinib (BGB324) in
Relapsed/Refractory AML and MDS", Professor Sonja Loges, attending physician at the
University Hospital in Hamburg-Eppendorf and lead investigator of
the BGBC003 trial, detailed the following:
- 14 of 26 (54%) of patients found to be AXL positive (denoted by
low serum AXL, sAXL, levels at start of treatment)
- Response rate of 43% CR/Cri/CRp to bemcentinib
monotherapy in AXL positive patients and 22% overall.
- Mild and manageable side effect profile with a low incidence of
Grade 3/4 events and low incidence of haematological toxicity.
Furthermore, the Company announces that enrolment is complete
into the phase II combination cohort of bemcentinib and decitabine
in first line AML. Analysis of the activity of the combination will
be submitted for presentation at a future medical congress.
Richard Godfrey, Chief Executive
Officer of BerGenBio, commented: "I am very encouraged by the
data presented today, we are consistently seeing AXL positive
patients report a superior response to bemcentinib therapy alone or
in combination with standard of care therapy. The value of our
biomarkers to identify patients most likely to benefit from
bemcentinib is tremendous. Based on our clinical data, more than
50% of AML/MDS patients are AXL positive, of which 43% reported
complete response within the first few weeks of starting
bemcentinib monotherapy treatment. Bemcentinib is very well
tolerated by patients as a single agent and in combination with
other drugs, which is an important feature supporting bemcentinib's
broad utility. We are making excellent progress recruiting the
chemotherapy combination arms of this study and look forward to
reporting the data from these patients in the coming
months".
About AML
AML is the most common form of acute leukaemia in adults where
malignant AML blasts interfere with the normal functioning of the
bone marrow leading to a multitude of complications like anaemia,
infections and bleeding. AML is diagnosed in over 20,000 patients
in the US annually and is rapidly lethal if left untreated.
Successful treatment typically requires intensive therapy or bone
marrow transplantation, and relapse and resistance are common.
Consequently, there is an urgent need for effective novel therapies
in relapsed/refractory patients, particularly those that are
ineligible for intensive therapy or bone marrow transplant.
About the BGBC003 trial
The BGBC003 trial is a phase Ib/II multi-centre open label study
of bemcentinib as a single agent in patients with AML or high risk
MDS or in a combination with cytarabine and decitabine in AML
patients. Up to 75 patients will be enrolled at centres in the US,
Norway, Germany and Italy. For more information please access
trial NCT02488408 at www.clinicaltrials.gov.
About the 60th ASH Annual Meeting in San Diego, California
The 60th American Society of Haematologist Annual Meeting and
Exposition is the most comprehensive haematology conference
worldwide and attracts more than 25,000 haematology professionals
from every subspecialty.
About BerGenBio ASA
BerGenBio ASA is a clinical-stage biopharmaceutical company
focused on developing a pipeline of first-in-class AXL kinase
inhibitors to treat multiple cancer indications. The Company is a
world leader in understanding the essential role of AXL kinase in
mediating cancer spread, immune evasion and drug resistance in
multiple aggressive solid and haematological cancers.
BerGenBio's lead product, bemcentinib, is a selective, potent and
orally bio-available small molecule AXL inhibitor in four Company
sponsored Phase II clinical trials in major cancer indications,
with read-outs anticipated in the second half of 2018.
AXL kinase is 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.
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
Media Relations in Norway
Jan Petter Stiff, Crux Advisers
stiff@crux.no
+47-995-13-891
International Media Relations
David Dible, Mark Swallow, Marine
Perrier, Citigate Dewe Rogerson
bergenbio@citigatedewerogerson.com
+44-207-638-9571
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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