· 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
…
Vis børsmeldingen
study
Bergen, Norway, 6 DECEMBER 2020 - 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.
Kilde
