BERGEN, Norway, Nov. 11, 2020 /PRNewswire/ -- BerGenBio ASA
(OSE:BGBIO), a clinical-stage biopharmaceutical company developing
novel, selective AXL kinase inhibitors for severe unmet medical
need, will today present an updated clinical & translational
analysis from its Phase II bemcentinib and pembrolizumab
combination study (BGBC008) in advanced non-small cell lung cancer
(NSCLC), at an oral presentation at the Society for Immunotherapy
of Cancer (SITC) 35th Annual Meeting.
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 16
refractory NSCLC patients previously treated with a PD-L1 or PD-1
checkpoint inhibitor (CPI) as a monotherapy.
"AXL is implicated in resistance to immunotherapy and this
study is based around the hypothesis that blocking AXL signalling
represents a novel approach to prevent cancer survival mechanisms
and to improve the efficacy of immuno-oncology
drugs,"
commented Professor James Spicer, PhD, who will give the
presentation at SITC. "Our findings from this interim
analysis suggest that bemcentinib has potential to reverse acquired
resistance to checkpoint inhibitors among previously treated
NSCLC patients by targeting AXL expressing macrophages and
regulatory dendritic cells. These encouraging results support the
further development of AXL inhibition as a means to extend the
efficacy of immunotherapy in biomarker-selected NSCLC
patients."
The combination of bemcentinib and pembrolizumab was overall
shown to be well tolerated and clinically active in CPI-refractory
composite AXL (cAXL) positive NSCLC. Of the evaluable patients in
Cohort B 58% were cAXL-positive, 25% were PD-L1 negative
(<1%TPS), and 42% patients were PD-L1 low positive (1-49% TPS).
86% of cAXL-positive patients achieved clinical benefit (one
partial response, five stable disease) while none was observed in
cAXL negative patients.
The study demonstrated a median progression-free survival among
cAXL positive patients in Cohort B patients of 4.73 months,
compared with 1.87 months among cAXL-negative patients.
Full details of the presentation are as follows:
Title: A PhII study of bemcentinib, a first-in-class
selective AXL kinase inhibitor, in combination with pembrolizumab
in pts with previously-treated advanced NSCLC: Updated clinical
& translational analysis
Author: Professor James
Spicer, Professor of Experimental Cancer Medicine at King's
College London
Session/Abstract ID: Combinatorial Therapies, 362
Date/Time: 11 November
2020, 11.40am EST
The presentation will be made available on BerGenBio's website,
under `Presentations'.
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
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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