Regulatory Filings • Nov 9, 2021
Regulatory Filings
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BERGENBIO PRESENTS PRE-CLINICAL AND CLINICAL DATA ON BEMCENTINIB IN STK11-POSITIVE NSCLC AT SITC ANNUAL MEETING 2021
Bergen, Norway, 9 November 2021- BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL inhibitors for severe
unmet medical needs, is pleased to announce that it will deliver an e-poster
presentation at the Society for Immunotherapy of Cancer (SITC) 36th Annual
Meeting, taking place online from 10th-14th November 2021.
The e-poster presentation provides pre-clinical and clinical data suggesting
that bemcentinib restored response to anti-PD-1 treatments in non-small cell
lung cancer (NSCLC) patients harboring STK11 mutations. STK11 is an important
tumor suppressor gene reported in some studies to confer immunotherapy
resistance in NSCLC. STK11 mutations are present in about 10-20% of NSCLC
patients.
In pre-clinical NSCLC mouse models harboring STK11 mutations, sensitivity to PD
-1 blockade was evaluated in the absence and presence of bemcentinib. Systemic
inhibition of AXL with bemcentinib resulted in the expansion of tumor-associated
T cells and restored therapeutic response to anti-PD-1 check point inhibition.
In parallel, data from BerGenBio's Phase II bemcentinib and pembrolizumab
combination study (BGBC008) in advanced NSCLC showed that 3 of 3 evaluable
patients with identified STK11 mutations demonstrated objective clinical
response / clinical benefit to the combination of bemcentinib and pembrolizumab.
Martin Olin, Chief Executive Officer at BerGenBio, commented: "While the data
are limited, they suggest a mechanism by which treatment with bemcentinib could
restore sensitivity to anti-PD-1 treatment in NSCLC patients harboring STK11
mutations. Up to 20% of the NSCLC patient population has been reported to harbor
STK11 mutations representing a large subgroup of NSCLC."
Mutations in the tumor suppressor STK11/LKB1 have in some studies been reported
as associated with negative predictive and prognostic impact in NSCLC patients
receiving anti-PD-1/PD-L1 treatments. STK11 mutant tumors are characterized by a
suppressive tumor micro-environment devoid of cytotoxic T cells. The study
hypothesized that targeting the receptor tyrosine kinase AXL, a known driver of
an innate immune suppressive microenvironment, would restore sensitivity to PD-1
blockade in pre-clinical models as well as in patients harboring STK11 mutated
NSCLC.
Full abstracts are available on the SITC website here:
https://www.sitcancer.org/2021/home
Full details of the presentation are below.
Title: AXL targetingwithbemcentinibrestores PD-1 blockade sensitivity
ofSTK11/LKB1mutant NSCLC throughinnate immune cellmediatedexpansion of TCF1+CD8T
cells
Author: Rolf A. Brekken et al.
Session/Abstract ID: 602
The presentation will be made available on BerGenBio's website, under
'Presentations (https://www.bergenbio.com/investors/presentations/)'.
-Ends-
Contacts
Martin Olin
Chief Executive Officer, BerGenBio ASA
Rune Skeie
Chief FinancialOfficer, BerGenBio ASA
International Media Relations
Mary-Jane Elliott, Chris Welsh, Lucy Featherstone
Consilium Strategic Communications
+44 20 3709 5700
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 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 potentially 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
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. Suchrisks, 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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