Regulatory Filings • Dec 9, 2019
Regulatory Filings
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BerGenBio presents preliminary clinical data from Phase II combination trial of bemcentinib and LDAC in elderly AML patients at ASH 2019
· Phase II trial evaluating bemcentinib in combination with low-dose cytarabine
(LDAC) in elderly AML patients unfit for intensive therapy is well tolerated
and shows promising efficacy
· Long duration of response (>9.9 mo, still maturing) with 50% CR/CRi in 6
evaluable newly diagnosed patients receiving the bemcentinib-LDAC combination.
· Clinical benefit demonstrated in >2L relapsed and refractory AML patients
with 1 CR/CRi and 3 SD out of 6 evaluable patients
· Pretreatment sAXL holds as predictive of response
Bergen, Norway, December 9, 2019 - BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
multiple cancer indications, will today provide an update from the Company's
phase II study of bemcentinib (BGB324), a first-in-class highly selective oral
AXL inhibitor, in combination with low-dose cytarabine (LDAC) in elderly AML
patients in a poster presentation at the 61st Annual American Society of
Hematology (ASH) Meeting, being held from 7-10 December in Orlando, Florida.
The bemcentinib-LDAC combination was safe and well tolerated in elderly AML
patients and showed promising efficacy among both newly diagnosed and
relapsed/refractory AML patients. The overall response rate and duration surpass
historical benchmarks and compare favorably to other LDAC combinations.
Pretreatment sAXL holds as a predictive biomarker in AML patients treated with
the combination, and a new novel blood based predictive biomarker is identified
and associated with clinical benefit in AML and Lung cancer patients receiving
bemcentinib.
Professor Sonja Loges, attending physician and principal investigator,
University Medical Centre Hamburg Eppendorf, Germany commented: "I am very
encouraged by these early results. The duration of response and successful
treatment beyond progression are consistent with the previously reported
immunomodulatory activity of bemcentinib. I look forward to conducting a deeper
analysis of AXL signalling in tumor and immune cells from patient biopsy samples
to further elucidate this unique mechanism-of-action."
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "This
combination trial of bemcentinib with low-dose cytarabine continues to show
promising results in AML patients who are unable to tolerate intensive
chemotherapy and have limited treatment options. The current data further
highlight the novel tumor-immune effects of bemcentinib observed in previous
cohorts and in other cancer types. Although these are early findings, we are
encouraged by the response rate and duration, and we are focused on advancing
our late stage development programme."
Details of the presentation are below.
Title: Durable responses observed in elderly AML patients unfit for intensive
chemotherapy with first-in class selective AXL inhibitor bemcentinib (BGB324) in
combination with LDAC: Phase II open-label study
Date: Monday 9th December 2019
Session Name: 616. Acute Myeloid Leukemia: Novel Therapy, excluding
Transplantation: Poster III
Time, Location: 6:00 PM - 8:00 PM, Orange County Convention Center, Hall B
The poster will be available at www.bergenbio.com in the section:
Investors/Presentations from 14.00 CET Monday 9[th] December 2019.
- END -
About AML and the BGBC003 trial
Acute myeloid leukaemia (AML) is a rapidly progressing blood cancer. 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.
The BGBC003 trial is a phase Ib/II multi-centre open label study of bemcentinib
in combination with cytarabine (part B2) and decitabine (part B3) in patients
with AML who are unsuitable for intensive chemotherapy as a result of advanced
age or existing-co-morbidities. Up to 28 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 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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