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2024-03-20 17:15:12
BerGenBio receives positive recommendation from independent
Data and Safety Monitoring Board to proceed without study modification
Bergen, Norway, March 20, 2024, - BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical needs, announced today it has initiated the Phase 2a
portion of the BGBC016 clinical study of its selective AXL inhibitor bemcentinib
in combination with standard of care therapy in first-line Non Small Cell Lung
Cancer (NSCLC) patients harboring a STK11 mutation (STK11m).
The initiation of Phase 2a follows apositive recommendationby the independent
Drug Safety Monitoring Board (DSMB) which evaluated the safety of the
combination of bemcentinib with pembrolizumab (Keytruda®) and doublet
chemotherapy in first-line (1L) NSCLC patients enrolled in the Phase 1b portion
of the study.
Patients with STK11m NSCLC have a significantly poorer response to current
therapies, including immune checkpoint inhibitors, when compared with patients
with wild-type (non-mutated) STK11. AXL plays a significant role in the survival
and spread of cancer and STK11m NSCLC patients have a high expression of AXL
suggesting that AXL is an important target to prevent disease progression and
resistance to existing therapies. Bemcentinib's selective inhibition of AXL has
been shown to improve the response to immune checkpoint inhibition in STK11m
patient-derived preclinical models and in early clinical studies. There are
currently no targeted therapies available for the STK11m NSCLC patient
population, which represents up to 20% of 1L NSCLC patients.
Cristina Oliva, Chief Medical Officer of BerGenBio commented, "We are very
pleased that no new safety signals have been identified and are encouraged by
the recommendation of the DSMB to continue the study as planned. We have
therefore, opened the Ph2a portion of the study with the goal of reporting
initial efficacy data as the next step in validating the benefit of bemcentinib
in combination with standard therapies in 1L NSCLC."
Martin Olin, Chief Executive Officer of BerGenBio added, "The high unmet medical
need in 1L STK11m NSCLC patients is widely recognized. Bemcentinib represents a
novel treatment modality which may significantly improve the outcome for
patients, and we are pleased to have achieved this important milestone."
Contacts
Martin Olin CEO, BerGenBio ASA
ir@bergenbio.com
Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com
Investor Relations / Media Relations
Jan Lilleby
jl@lillebyfrisch.no
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 cancer and severe respiratory infections. The
Company is focused on its proprietary lead candidate, bemcentinib, a potentially
first-in-class selective AXL inhibitor in development for STK11 mutated NSCLC
and severe respiratory infections. 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, visitwww.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. 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 subject to the disclosure requirements pursuant to
section 5-12 of the Norwegian Securities Trading Act.