Earnings Release • Jan 13, 2021
Earnings Release
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BERGENBIO TO PRESENT UPDATES FROM ONGOING PHASE II BEMCENTINIB COMBINATION STUDY IN REFRACTORY NSCLC AT WCLC 2020
· Bemcentinib in combination with pembrolizumab was well-tolerated and showed
promising clinical activity in refractory lung cancer
· Updated interim data will be presented on second line patients following CPI
monotherapy
Bergen, Norway, 13[th] January 2021 - BerGenBio ASA (OSE:BGBIO), a clinical
-stage biopharmaceutical company developing novel, selective AXL kinase
inhibitors for severe unmet medical need, will present an update from its Phase
II study of bemcentinib in combination with anti-PD-1 therapy pembrolizumab
(BGBC008) in refractory non-small cell lung cancer (NSCLC) patients at an oral
presentation at the 2020 World Conference on Lung Cancer Singapore (WCLC).
BGBC008 is a Phase II single-arm, two stage study with bemcentinib and
pembrolizumab for previously treated Stage IV NSCLC patients, comprising three
cohorts; chemotherapy failed patients not treated with immunotherapies (post
-chemo), patients progressing on prior checkpoint inhibitor therapy (post-CPI
monotherapy) and platinum-doublet chemotherapy in combination with immunotherapy
(post-chemo-CPI).
The primary endpoint of the study was Overall Response Rate with pre-defined
criteria to proceed from the first to second stage in each cohort. Secondary
endpoints included Disease Control Rate, Progression Free Survival, Overall
Survival and safety.
The interim data shows that bemcentinib in combination with pembrolizumab was
well-tolerated and shows promising clinical activity in refractory lung cancer.
The presentation will provide updated data from Cohort B of the study, assessing
the safety and efficacy of bemcentinib in combination with anti-PD-1
therapy pembrolizumab, in refractory NSCLC patients previously treated with a PD
-L1 or PD-1 checkpoint inhibitor (CPI) as a monotherapy.
The full abstract can be found on the WCLC
website (https://library.iaslc.org/conference
-program?product_id=20&author=&category=&date=&session_type=&session=&presentatio
n=&keyword=bemcentinib&cme=undefined&), and details of the presentation are
below.
Title: A phase II study of the oral selective AXL inhibitor bemcentinib with
pembrolizumab in refractory patients with advanced NSCLC
Presenting Author: Dr. Matthew G. Krebs PhD.
Session/Abstract ID: Immunotherapy (Phase II/III Trials) / # 3647
Date/Time: Friday 29[th] January 2021 at 09.50 Singapore Time / 02.50 CET
The presentation will be available on BerGenBio's website from 29[th] January
- END -
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 expression defines a very poor prognosis
subgroup in most cancers. 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, therapy 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,
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 companion diagnostic tests to identify 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
+47 917 86 513
International Media Relations
Mary-Jane Elliott, Chris Welsh, Lucy Featherstone, Carina Jurs
Consilium Strategic Communications
+44 20 3709 5700
Media Relations in Norway
Jan Petter Stiff, Crux Advisers
+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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