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2024-07-29 07:00:04
BerGenBio receives positive recommendation from independent
Data and Safety Monitoring Board to initiate second dose in Ph2a of BGBC016
trial
Bergen, Norway, July 29, 2024, - BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical needs, announced today that the independent Data and Safety
Monitoring Board (DSMB) for BerGenBio's Phase 1b/2a BGBC016 study confirmed
acceptable safety at the highest dose tested in the Phase 1b. As a result, the
DSMB also recommended that under the study protocol, no additional patients will
be required for Phase 1b.
The recommendation of the DSMB allows BerGenBio to proceed per study protocol
and open the second dose level in the Phase 2a part of the study in NSCLC
patients with STK11 mutations. This portion of the study is already open for
enrollment and is designed to evaluate the efficacy of the combination of
bemcentinib with pembrolizumab (Keytruda®) and doublet chemotherapy.
Cristina Oliva, Chief Medical Officer of BerGenBio commented, "We continue to be
reassured by the safety profile of bemcentinib when combined with the standard
of care for 1L NSCLC patients. Opening the second dose level in the Phase 2a
portion of the BGBC016 study will allow us to carefully evaluate the dose
response to bemcentinib, an important goal to guide the dose optimization for
future trials."
Martin Olin, Chief Executive Officer of BerGenBio added, "The BGBC016 clinical
trial is our highest priority, and I am happy to see it continues to progress as
planned. NSCLC STK11m patients are not currently eligible for targeted therapy
and unfortunately face a very poor prognosis. The medical need is significant,
and so are the commercial opportunities.
The Phase 2a is assessing the safety and efficacy of two different doses of
bemcentinib in the same treatment combination. As previously communicated, the
company expects to present an interim analysis in the second half of this year.
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 STK11m NSCLC
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.
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 subject to the disclosure requirements pursuant to section 5
-12 of the Norwegian Securities Trading Act.