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 Trading Act.

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