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quarter and first half ended June 30, 2023, and provided a business update.
A briefing by BerGenBio’s senior management team will take place at 10:45 am
CEST today via a webcast presentation, followed by a Q&A session. Please see
below for details.
“For the second quarter we are pleased to report the outcomes of our cost
-savings efforts and the successful closure of the Rights Issue. In combination
this will fund our planned activities into the fourth quarter of 2024 and
potentially into the second half of 2025 if all granted warrants at the Rights
Issue are exercised. Our highest priority is to progress the ongoing Phase 1b/2a
clinical trial in first-line STK11m NSCLC patients (“BGBC016”) where we are
working towards enrolling the Phase 1b cohorts and initiate the Ph 2a part.
During the second quarter, we obtained a wealth of additional clinical data
which further validate the efficacy and tolerability of our lead compound
bemcentinib. The data provide us with strong confidence in our focused strategy
to study the compound’s potential to treat 1L NSCLC patients harboring STK11
mutations. Further, explorative biomarker data from our BGBC008 trial (2L NSCLC)
indicate that bemcentinib in combination with pembrolizumab provides encouraging
survival benefits in patients harboring other hard-to-treat mutations such as
KRAS and KEAP1. During 2023, we have seen increased awareness for the need for
improved treatments for this prevalent patient population with high unmet
needs.”, said Martin Olin, Chief Executive Officer of BerGenBio.
Clinical Development
Bemcentinib
BerGenBio’s lead compound, bemcentinib, is a potentially first-in-class, oral,
highly selective inhibitor of the receptor tyrosine kinase AXL, which is
expressed and activated in response to oxidative stress, inflammation, hypoxia
and drug treatment, resulting in several deleterious effects in cancer and
severe respiratory infections. Bemcentinib selectively inhibits AXL activation
to prevent the progression of serious diseases through the modulation of
resistance mechanisms and the adaptive immune system.
Bemcentinib is currently being developed in 1L STK11 mutated NSCLC and severe
respiratory infections. Its novel mechanisms of action and primary accumulation
in the lungs uniquely position it to address these severe lung diseases.
Oncology: NSCLC
1L STK11m NSCLC (BGBC016)
We continue to advance our focused strategy through the conduct of BGBC016, a
global, open-label Phase 1b/2a trial designed to determine the safety,
tolerability and efficacy of bemcentinib in combination with standard of care
treatments in untreated advanced/metastatic non-squamous NSCLC patients with
STK11 mutations and no actionable mutations. Sites in the US have been
activated and enrolment is ongoing while expansion into European sites is well
underway, with regulatory approval to proceed received from regulatory
authorities in the US and several European countries.
The Phase 1b portion of the study is evaluating the safety and feasibility of
three different doses of bemcentinib in combination with pembrolizumab and
doublet chemotherapy in 1L advanced/metastatic non-squamous NSCLC patients,
regardless of STK11 status. The Phase 2a expansion will assess the safety and
efficacy of up to two doses of bemcentinib in the same treatment combination in
1L advanced/metastatic non-squamous NSCLC patients with STK11 mutations.
A significant subgroup comprising of up to 20 % (> 30,000 patients in US and
EU5) of 1L non-squamous NSCLC patients harbor STK11 mutations, which are
associated with immunosuppression and poor prognosis with standard 1L NSCLC
treatment. Data suggests that STK11m NSCLC patients almost universally express
AXL in tumors and/or on immune cells, resulting in the development of drug
resistance, immune evasion, and metastases.
The data from the BGBC008 (2L+ NSCLC, bemcentinib in combination with
pembrolizumab) and BGBIL005 (2L+ NSCLC, bemcentinib in combination with
docetaxel) trials provide clinical evidence of the anti-tumor effects of
bemcentinib and its ability to modulate the tumor microenvironment to enhance
the effects of immunotherapy and chemotherapy. We believe that the reversal of
the effects of AXL with bemcentinib holds the promise of providing substantial
survival benefits to NSCLC patients and specifically in patients harboring
STK11m and potentially other hard-to treat mutations such as KRAS and KEAP1.
2L+ NSCLC Trial (BGBC008)
Additional biomarker analyses of the BGBC008 data in the second quarter yielded
promising data which further support the potential for bemcentinib in our on
-going 1L STK11m NSCLC trial and may represent an opportunity to further expand
the patient population that may benefit from the addition of bemcentinib to
their treatment regimens. The Ph2 BGBC008 trial enrolled 90 evaluable 2L+ NSCLC
patients who had received at least one prior line of therapy:chemotherapy,
immunotherapy or the combination.
· An updated analysis of AXL biomarker status indicates that the presence of
AXL expression on either tumor cells and/or immune cells is predictive of
improved survival in patients treated with bemcentinib + pembrolizumab. The vast
majority (88%) of patients met the criteria for AXL presence (AXL positive
patients) and obtained clinically meaningful benefits:
· Median overall survival was highly statistically significant at p=0.001 in
AXL positive vs. AXL negative patients (14.1 mos. vs 6.5 mos).
· Median progression free survival was 6.0 mos. in AXL positive patients vs.
5.8 AXL negative patients
· Analysis of available data for patients treated in a subsequent therapies
(3L+) following treatment with bemcentinib + pembrolizumab in 2L identified a
higher than expected response rate, potentially pointing to long-lasting immune
response benefits.
· Data from the BGBC008 study also indicate that patients with PD-L1 negative
(TPS score <1) benefit from the combination treatment of bemcentinib and
pembrolizumab.
· Currently the PD-L1 negative patient population is not widely treated with
immune checkpoint inhibitors potentially providing an opportunity to expand the
patient population eligible for treatment.
· The combination ofbemcentinib and pembrolizumab appeared to benefit patients
with mutations associated with pooroutcome with available therapies, including
STK11, KRAS, KEAP-1 andSMARCA4 mutations. These mutational patient populations
may represent an incremental opportunity for bemcentinib and will be further
assessed in our on-going BGBC016 study in 1L patients.
Oncology: Relapsed/Refractory AML/MDS
In the second quarter, topline results of the Phase 1b/2a BGBC003 multicenter
open-label studyofbemcentinibas a single agent and in combination with low-dose
cytarabine (LDAC) ordecitabine in patients with acute myeloid leukemia or as a
single agent in patients withmyelodysplastic syndrome.
· Two cohorts of patients in BGBC003 were treated withbemcentinibas a single
agent(monotherapy). In Cohort B1, in patients with Relapsed/Refractory (R/R)
AML, (n=11),bemcentinib provided an ORR of 18.2% and a mOS of 18 months.In
Cohort B4, in patientswith relapsed/high risk MDS,bemcentinibmonotherapy
provided an ORR of 18.8% with a mOSof 9.2months.
· Furthermore,bemcentinibin combination with the chemotherapy LDAC appeared to
provide substantial mOSbenefit to patients with R/R AML (n=27) achieving an ORR
of 18.5% and a mOS of 8months.
Oncology: Mesothelioma
In the second quarter, topline results of the investigator led BGBIL011/MiST3
mesothelioma trial were presentedon June 5, 2023, in an oral presentation at the
2023 American Society of ClinicalOncology (ASCO) meeting in an abstract
titled:Bemcentiniband pembrolizumab in patients withrelapsed mesothelioma:
MiST3, a phaseIIatrial with cellular and molecular correlates of efficacy.
Key results include:
· 26 patients with relapsed mesothelioma were enrolled inMiST3and all received
at least onedose ofbemcentiniband pembrolizumab.
· The primary endpoint of disease control rate at 12 weeks (DCR12w) was met:
46.2% (90% CI:29.2, 63.4).
· Secondary endpoints included a disease control rate at 24 weeks (DCR24w) of
38.5% (95% CI:20.2, 59.4) and an overall response rate of (ORR) of 15.4% (95%
CI: 4.4, 34.9).
· The combination ofbemcentiniband pembrolizumab was generally safe and well
-tolerated.
In totality, the Company is very encouraged by the additional clinical data
generated with bemcentinib and reported year-to-date 2023. Our current
activities are focused on 1L NSCLC STK11m patients; however, we believe these
additional datasets may expand the potential beyond STK11m NSCLC patients to
other hard-to-treat mutations.
Severe Respiratory Infections (SRIs)
The Company believes thatbemcentinibblocks viral entry and replication,
stimulates the innateimmune system, and promotes lung tissue repair positioning
it well for the treatment of severerespiratory infections.
On April 25, 2023, the Company decided to pause the Phase2b trial
evaluatingbemcentinibin hospitalized COVID-19 patients until a potential
accelerationin hospitalizations warrant further evaluation ofbemcentinibin this
population.
Bemcentinibis currently being evaluated in preclinical studies for SRIs causing
Acute RespiratoryDistress Syndrome (ARDS) and initial results are expected
during 2023.
Corporate Activities
Rights Offering
On June 13, 2023, the Company completed a rights issue raising gross proceeds
ofNOK 250m.The proceeds from this offering including any additional proceeds
from the exercise of warrants will be dedicated to the conduct of BGBC016 in 1L
STK11mNSCLC patients, preclinical studies in severe respiratory infections and
forgeneral corporatepurposes.
Focused organizational structure aligned with strategy
The Company has taken measures to further reduce its operational costs
includinga significant reduction in workforce and total compensation to the
executive management andthe board of directors. This includes a transition of
the CSO to a part-time consultancy position. These prudent actions will reduce
total operating expenses by at least30% compared to historic operational
expenses when fully implemented.
Second Quarter 2023 Financial Highlights
(Figures in brackets = same period 2022 unless otherwise stated)
· Revenue was NOK 0 million (NOK 0 million) for the second quarter.
· Total operating expenses for the second quarter were NOK 47.8 million (NOK
88.2 million).
· The operating loss for the quarter came to NOK 47.8 million (NOK 88.2
million).
· Cash and cash equivalents amounted to NOK 226 million by the end of June
2023 (NOK 73.0 million by end of March 2023). This includes the net proceeds
from the Rights Issue completed in June 2023.
The Q2 2023 presentation and Financial Report is available at the Company’s
website (Financial reports - BerGenBio).
Presentation and Webcast Details
The live webcast
link (https://channel.royalcast.com/landingpage/hegnarmedia/20230823_8/) is
available at www.bergenbio.com in the Investors/Financial Reports section.
A recording will be available shortly after the webcast has finished.
https://channel.royalcast.com/landingpage/hegnarmedia/20230823_8/ (https://eur03.
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Contacts
Martin Olin CEO, BerGenBio ASA
ir@bergenbio.com
Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com
Media Relations
Jan Lilleby
jl@lillebyfrisch.no
+47 90 55 16 98
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.
Kilde
