BerGenBio's Bemcentinib Meets Efficacy Endpoint in BERGAMO Phase II Trial with High Risk Myelodysplastic Syndromes or Acute Myeloid Leukemia

 

· Primary endpoint of overall response rate was met in the fully recruited
single arm phase II study

Bergen, Norway,18 August 2020 - BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
unmet medical need, announces that the primary endpoint of overall response rate
has been met in the BERGAMO Phase II Trial investigating BerGenBio's selective
AXL inhibitor bemcentinib in patients with High Risk Myelodysplastic Syndromes
(HR-MDS) or Acute Myeloid Leukemia (AML), for whom treatment with
hypomethylating agents (HMAs) is ineffective.

The multicenter phase 2 BERGAMO trial (NCT03824080) evaluated the safety and
efficacy of bemcentinib monotherapy in patients with  HR-MDS or AML who were
refractory to or in relapse after at least six or four cycles of the HMAs
azacitidine (AZA) or decitabine (DAC), respectively. HMAs represent the current
standard of care in both indications for patients not eligible for intensive
chemotherapy or allogeneic stem cell transplantation. The study enrolled 45
eligible patients from 10 sites across Germany, France and the Netherlands.

The primary endpoint was met and included overall response rate (CR, CRi, PR or
SD) assessed after 4 treatment cycles. All patients who achieved CR, CRi, PR or
SD after 4 cycles of bemcentinib were considered as responders and allowed to
continue treatment for a total of up to 9 cycles. Non-responding patients
stopped treatment after 4 cycles. Secondary endpoints of the trial include a
translational project evaluating the role of biomarkers and response.

The BERGAMO trial is an investigator sponsored trial co-ordinated by The
European Myelodysplastic Syndromes Cooperative Group (EMSCO). The chief
investigator is Prof. Uwe Platzbecker, MD, from Leipzig University Hospital,
Germany, and the study included 10 clinical research sites in Germany, France
and Netherlands.

Further details of results of the BERGAMO trial will be presented at appropriate
scientific medical conferences later in 2020.

Richard Godfrey, Chief Executive Officer of BerGenBio, said: "These headline
results are in-line with previously reported efficacy data on bemcentinib in
relapsed MDS and AML patients. Despite recent improvements of first line
treatment options there remains a substantial need for novel therapeutics which
target difficult-to-treat patient groups including patients with HR-MDS and AML
who have failed front-line therapy with hypomethylating agents. This is a group
with a very poor prognosis so we are very encouraged by these data and believe
they provide further validation for our clinical development strategy in these
indications.''

- END -

About MDS and AML

Hypomethylating agents (HMAs) are the standard of care for patients with higher
-risk myelodysplastic syndrome (HR-MDS) or acute myeloid leukemia (AML), not
eligible for intensive chemotherapy or allogeneic stem cell transplantation.
However, the majority of patients do not respond to these agents or relapse,
still having a dismal outcome with very limited treatment options available.

Bemcentinib (BEM) is a selective small molecule inhibitor of AXL, a surface
membrane protein kinase receptor mediating resistance to chemotherapeutic agents
and decreased antitumor immune response. AXL is overexpressed on leukemic cells,
especially in the stem cell compartment, and represents a potential novel target
in patients with MDS and AML.

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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