BERGENBIO RECEIVES FDA FAST TRACK DESIGNATION FOR BEMCENTINIB / ANTI-PD-(L)1 COMBINATION IN NSCLC

 

First recognition by a regulator of AXL-positive patients as a target population

Bergen, Norway, 08 June 2021?- BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical need, today announces that the U.S. Food and Drug
Administration (FDA) has granted Fast Track designation for bemcentinib in
combination with an anti-PD-(L)1 agent for the treatment of patients with AXL
-positive advanced/metastatic non-small cell lung cancer (NSCLC).

The FDA's decision represents the first recognition by a regulator of AXL
-positive patients as a molecular targetable patient population. This
designation has been granted for patients without actionable mutations, with
disease progression on or after treatment with an anti-PD-(L)-1 agent, with or
without chemotherapy as their first line of therapy.

Fast Track designation is intended to facilitate the development and review of
drugs used to treat serious conditions and to fill an unmet medical need. It
will enable BerGenBio to have more frequent interactions with the FDA throughout
the drug development process, so that an approved product can reach the market
faster.

The designation also provides Eligibility for Accelerated Approval, enabling
approval based on a surrogate clinical endpoint: Priority Review, which allows
New Drug Application (NDA) review in six months instead of 10, if relevant
criteria are met: and eligibility for Rolling Review, whereby the Company will
be able to submit completed sections of its NDA for review by the FDA before
complete application is submitted.

BerGenBio has developed proprietary biomarkers and companion diagnostic assays
for selection of AXL positive patients, the cAXL assay is validated for clinical
trial use. Retrospective analysis of patients in clinical trials suggest
approximately 50% of patients are cAXL positive, and it is these patients that
achieve the clinical responses and extended survival benefit previously
reported.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "Building on
our encouraging clinical and translational data, we are excited to receive Fast
Track designation from the FDA for the promising combination of bemcentinib in
combination with a checkpoint inhibitor. This regulatory milestone is
particularly meaningful for BerGenBio, as it represents the first formal
recognition by a regulator of AXL-positive patients as a discernible patient
population and serves as further validation of our belief that AXL inhibition
has high potential as a cornerstone of cancer combination therapy. We look
forward to working closely with the FDA on the continued clinical development of
the combination."

-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

Composite AXL (cAXL) is a proprietary biomarker developed by BerGenBio that
simultaneously scores AXL expression on tumour cells and immune cells in the
tumour microenvironment, as determined by Immune Histo Chemistry (IHC) assay.
Data from on-going clinical trials suggest ca. 50% of patients are high cAXL and
this is predictive of improved clinical outcomes for patients receiving
bemcentinib.

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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