- Clinical benefit rate of 73% reported in second line
relapsed AML patients. Overall Response OOR 45%, CR/CRi rate of
36%
- Median treatment duration exceeding 6 months with some
patients remaining on study
BERGEN, Norway, Dec. 6, 2020 /PRNewswire/ -- BerGenBio ASA
(OSE: BGBIO), a clinical-stage biopharmaceutical company developing
novel, selective AXL kinase inhibitors for severe unmet medical
need, will present updated clinical data from two Phase II studies
of bemcentinib in acute myeloid leukemia and high-risk
myelodysplastic syndrome, in two poster sessions at the American
Society of Hematology (ASH) Annual Meeting being held virtually
from 5-8 December 2020.
Dr Sonja Loges will provide an
update from the Company's Phase II study of bemcentinib (BGBC003)
in combination with low dose cytarabine (LDAC) in elderly
previously treated, relapsed and refractory AML patients.
The data indicates that treatment with the bemcentinib-LDAC
combination shows promising efficacy in relapsed patients who are
unfit for intensive chemotherapy. Of 11 evaluable relapsed patients
a response rate of 45% to date has observed. CR/CRi rate was 36%
with durable responses observed, and clinical benefit observed in
eight patients (73%) to date. Although the study is ongoing,
patients remain on drug, with median treatment of 6.2 months in CR
patients.
The Company is currently undertaking an in-depth translational
research program aiming to identify predictive molecular and
biological factors associated with response.
Dr Sonja Loges, Principal
Investigator on the trial commented "The current
prognosis for relapsed AML patients is very bleak, so we are
pleased to see such a positive clinical benefit rate in relapsed
second line patients with many patients remaining on drug for
extended durations. We are currently undertaking an analysis to
identify the suspected immune based factors that potentiate the
effects of the drug in certain patients. We hope that this will
enable us to identify specific biomarkers that will help us decide
which patients may benefit most from treatment with bemcentinib."
Details of this Poster presentation as follows:
Title: The Combination of AXL Inhibitor
Bemcentinib and Low Dose Cytarabine Is Well Tolerated and
Efficacious in Elderly Relapsed AML Patients: Update from the
Ongoing BGBC003 Phase II Trial (NCT02488408)
Date: Sunday, December 6,
2020
Session name: 613. Acute Myeloid Leukemia:
Clinical Studies: Poster II
Time: 7.00am - 3.30pm
(Pacific Time) / 4.00pm - 12.30am
(CET)
Abstract:
https://ash.confex.com/ash/2020/webprogram/Paper136566.html
An update will also be presented from the fully recruited
investigator sponsored BERGAMO Phase II Trial investigating
bemcentinib monotherapy in patients having relapsed treatment with
hypomethelating agents (HMAs) with High Risk Myelodysplastic
Syndromes (HR-MDS) or Acute Myeloid Leukemia (AML).
The primary endpoint of overall response rate (ORR) was met,
with the MDS cohort achieving a 36% response rate, while 8.3% of
patients with AML achieved stable disease. Three patients remain on
drug, with median treatment exceeding 8 months. A comprehensive
translational research program is ongoing to identify and verify
soluble plasma biomarkers, including sAXL, that continue to be
predictive of response.
Richard Godfrey, Chief
Executive Officer of BerGenBio, said: "We are pleased to
continue sharing updates from our phase II clinical studies
assessing bemcentinib with the scientific and medical community.
Data from both of the studies being presented at ASH continue to
show encouraging results in patients with a very poor prognosis
with current treatment options. We believe these data provide
further validation for our clinical development strategy in these
indications as we prepare to progress bemcentinib into late stage
randomised trials."
Details of this Poster presentations as follows:
Title: Efficacy and Safety of Bemcentinib in
Patients with Myelodysplastic Syndromes or Acute Myeloid Leukemia
Failing Hypomethylating Agents
Date: Saturday, December 5, 2020
Session name: 637 Myelodysplastic
Syndromes - Clinical Studies: Poster I Hematology Disease
Topics & Pathways: Diseases, Therapies, MDS,
Myeloid Malignancies, Clinically relevant
Time: 7.00am -
3.30pm (Pacific Time) / 4.00pm -
12.30am (CET)
Abstract: https://ash.confex.com/ash/2020/webprogram/Paper140240.html
Presentations will be made available at our website
www.bergenbio.com under Investors/Presentations at the date of
the conference.
-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
chemotherapy 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
low dose decitabine (part B3 & B5) in patients with AML who are
unsuitable for intensive chemotherapy as a result of advanced age
or existing-co-morbidities.
For more information please access trial NCT02488408 at
www.clinicaltrials.gov.
About MDS
Myelodysplastic syndromes (MDS) are stem cell disorders
characterised by a decreased ability of the bone marrow to produce
normal blood cells and platelets. MDS is associated with increased
risk of developing AML and immune dysfunctions are seen in patients
both with lower and higher-risk MDS. Hypomethylating agents (HMAs)
are the standard of care for patients with higher-risk
myelodysplastic syndrome not eligible for intensive chemotherapy or
allogeneic stem cell transplantation. However, the majority of
patients do not respond to these agents or relapse, and face a
dismal outcome with very limited treatment options available.
Hence, there is an urgent need for novel therapies to treat
MDS
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, 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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