BERGENBIO PRESENTS ENCOURAGING UPDATED PRELIMINARY DATA FROM PHASE II STUDY IN RELAPSED AML PATIENTS AT EHA VIRTUAL MEETING

 

Encouraging updated preliminary survival data more than double standard of care

reported in relapsed AML patients

Bergen, Norway, 11 June 2021?- BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical need, will present updated preliminary survival data from
the ongoing Phase II study of bemcentinib (BGBC003) in combination with low dose
cytarabine (LDAC) in elderly relapsed Acute Myeloid Leukaemia (AML) patients at
the European Haematology Association (EHA) 2021 Virtual Meeting, taking place
from 9-17 June 2021.

An update will be provided from an expansion cohort of 27 relapsed/refractory
AML patients, who were assessed to explore safety and efficacy together with
translational analysis.

The data indicate that the combination of bemcentinib, a once-daily oral AXL
-inhibitor and LDAC is efficacious and well tolerated in the elderly and unfit
relapsed AML population. Durable responses were observed in the relapsed AML
setting, with an overall response rate of 31% (5/16) and median overall survival
of 13.3 months, currently still immature and potentially subject to change.

In a subset of eleven relapsed AML patients, who received two or more cycles of
the combination, an increased clinical benefit was demonstrated: a CR/CRi rate
of 36% (4/11) was observed, coupled with encouraging overall survival to date
(median OS not reached at >16 months) with several subjects continuing on the
study. In contrast, historic controls of LDAC monotherapy suggest CR/CRi rates
of 13-17% with median survival rates of 4.1-5.6 months, as reported by Sarkozy
et al. (2015) and Wei et al. (2020).

An in-depth translational research program to identify predictive molecular and
biological factors associated with response is ongoing.

Ongoing dialogue continues with the FDA and EMA regulatory agencies to align on
a pathway for a pivotal registration trial for the combination
of bemcentinib and LDAC in relapsed elderly AML patients unfit for intensive
chemotherapy.

Dr. Sonja Loges, Principal Investigator of the trial, commented: "We were
impressed to see these positive responses in relapsed AML patients, for whom
treatment options are very limited under the current standard of care.
Interestingly, the first complete responses were reported at a relatively late
stage in the trial, between week 13 and 15. These later onset responses could
reflect the importance of AXL mechanisms in disease development as well as the
potential immune promoting benefits of bemcentinib treatment. Further clinical
investigation of this promising combination is therefore warranted."

Richard Godfrey, CEO of BerGenBio, commented: "We are very encouraged by this
promising preliminary response and survival data from the combination of
bemcentinib and LDAC in this patient population. Effective treatments with
meaningful survival benefit for relapsed AML patients is acknowledged as a
critical unmet medical need, this being a significant and rapidly growing
patient population as the first line treatment options improve.  We continue to
work closely with the regulators in Europe and the US to align on the way
forward to embark on late-stage pivotal trial of bemcentinib in this combination
and patient population."

The e-poster presentations are now available to watch online for registered
attendees here: https://ehaweb.org/congress/eha-congress-2021/program/featured
-sessions/.

Details of the e-poster presentation are below.

E-poster 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)

Abstract Number: EHA-2859

Session: 04. Acute Myeloid Leukaemia - Clinical

Date/Time: Available from 9am CEST on 11 June

-Ends-

About AXL

AXL kinase is a cell membrane receptor and an essential mediator of the
biological mechanisms underlying life-threatening diseases.

In COVID-19, AXL has two synergistic mechanisms of action, it acts a co-receptor
to ACE2, to which the spike protein of the SARS-CoV-2 virus attaches and enters
the host cell, and AXL expression is upregulated that leads to suppression of
the Type 1 Interferon immune response by host cells and in their environment.

Research data confirms bemcentinib inhibits SARS-CoV-2 host cell entry and
promotes the anti-viral Type I interferon response. Data from a Phase II in
human clinical trial has shown that treatment with AXL inhibitor bemcentinib
increased the rate ventilator free survival in hospitalised COVID-19 patients.

In cancer, increase in AXL expression has been linked to key mechanisms of drug
resistance and immune escape by tumour cells, leading to aggressive metastatic
cancers. AXL suppresses the body's immune response to tumours and drives
treatment failure across many cancers. High AXL expression defines a very poor
prognosis subgroup in most cancers. AXL inhibitors, such as bemcentinib,
therefore, have potential high value as monotherapy and as the cornerstone 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 including fibrosis.

About Bemcentinib

Bemcentinib (formerly known as BGB324), is a potential first-in-class, potent
and highly selective AXL inhibitor, currently in a broad phase II clinical
development programme. It is administered as an oral capsule and taken once per
day. Ongoing clinical trials are investigating bemcentinib in COVID-19, and
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.

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, therapy resistant cancers. The
company's proprietary lead candidate, bemcentinib, is a potentially first-in
-class selective AXL inhibitor in a broad phase II clinical development
programme focused on combination and single agent therapy in cancer, leukaemia
and COVID-19. A first-in-class functional blocking anti-AXL
antibody, tilvestamab, is undergoing phase I clinical testing. In
parallel, BerGenBio is developing a companion diagnostic test to identify
patient populations most likely to benefit from AXL inhibition: 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

ir@bergenbio.com

Richard Godfrey CEO, BerGenBio ASA

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 considered to be inside information pursuant to the EU
Market Abuse Regulation and is subject to the disclosure requirements pursuant
to section 5-12 of the Norwegian Securities Trading Act.
 

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