BerGenBio reports 43% response rate with bemcentinib monotherapy in AXL positive R/R AML/MDS patients at ASH

 

· 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
Bergen, Norway, 3 Dec 2018 - 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

-Ends-

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 Tr