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- BerGenBio to host conference call and webcast today at 10:00 AM CEST/4:00 AM
EDT -
BERGEN, Norway, August 23, 2022 - BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical needs, today announced financial results for the second
quarter and half year ended June 30, 2022 and provided a business update.
“The prioritization of bemcentinib development in two key areas in the second
quarter has created momentum entering the second half of the year,” said Martin
Olin, Chief Executive Officer of BerGenBio. “By following strong scientific
rationale, clinical and preclinical data, and areas of significant unmet medical
need, we are confidently enthusiastic about bemcentinib’s potential in aiding
patients in two indications of focus: STK11 mutated Non-Small Cell Lung Cancer
and patients hospitalized by COVID-19. The initiation of the next phase of
clinical development for both indications in 2H22 moves us a meaningful step
closer to addressing two large patient populations that are in need of better
treatments.”
Clinical Development
Bemcentinib
BerGenBio’s lead compound, bemcentinib, is a potent, first-in-class, oral, small
molecule, highly selective inhibitor of the receptor tyrosine kinase AXL, which
is overexpressed in response to cellular stress, inflammation, hypoxia and
chemotherapy. Bemcentinib inhibits the host cells’ ability to propagate the
progression of serious disease through the modulation of resistance mechanisms
and the adaptive immune system.
The Company is advancing bemcentinib development in two lung indications, STK11
mutated (STK11m) Non-Small Cell Lung Cancer (NSCLC) and Hospitalized COVID-19
patients, where bemcentinib’s novel mechanisms of action and primary
accumulation in the lungs make it uniquely positioned to address severe lung
diseases.
First-Line STK11m NSCLC
BerGenBio is preparing a Phase 1b/2a trial of bemcentinib in 1L STK11m NSCLC, a
group that represents approximately 20% of NSCLC patients. Mutations in the
STK11 gene are highly correlated with poor treatment response and survival with
today’s standard of care treatments, including immune checkpoint inhibitors in
NSCLC. Through inhibition of AXL, bemcentinib seeks to prevent AXL activation,
consequently removing the innate immunosuppression that it causes and driving
the proliferation of immune cells to restore sensitivity to immune checkpoint
therapy. UT Southwestern Medical Center in Texas has shown that bemcentinib in
models of NSCLC has the ability to restore the sensitivity of checkpoint
inhibitors. Further bemcentinib is also believed to delay the development of
chemoresistance.
· The detrimental effect of mutations in the STK11 gene on clinical outcomes
was further highlighted by several academic groups at the American Society of
Clinical Oncology (ASCO) meeting in June 2022. In a retrospective study funded
by Roche, Spain (Abstract #9047), of real-world outcomes in 1L NSCLC patients,
STK11m was identified as having the poorest prognosis in all effectiveness
outcomes, including lower response, progression free survival and overall
survival, of 185 detected mutations.
· The Company is preparing and has post period filed an IND with the purpose
to initiate a Phase 1b/2a trial evaluating bemcentinib in combination with a
checkpoint inhibitor and doublet chemotherapy in 1L STK11m NSCLC patients in the
second half of 2022.
· In parallel with the preparation of the Phase 1b/2a trial, the Company is
evaluating the role of STK11 mutations in combination with other relevant co
-mutations such as TP53, KRAS and KEAP1 to further characterize the potential of
bemcentinib is this area of high unmet medical need.
Hospitalized COVID-19 Patients
Bemcentinib is currently being studied in a Phase 2b clinical trial in
hospitalized COVID-19 patients. AXL, when induced by an infection, such as COVID
-19, is known to play a variety of key roles in transporting the virus into
cells, aiding replication, and dampening immune responses. Bemcentinib
selectively inhibits AXL to block viral entry, stimulate the innate immune
system and facilitate tissue repair regardless of known variants or mutations.
· In the ACCORD2 UK platform study of hospitalized COVID-19 patients,
bemcentinib treatment resulted in a clear reduction in clinical deterioration,
causing: a significant reduction in deaths, patients requiring less
supplementary oxygen, a significant reduction in the need for intubation or
ventilation and a shortening of hospital stays compared to the control group.
· Bemcentinib has been selected by an expert group to be studied in a Phase 2b
trial under the EU-SolidAct platform through a sub-protocol enrolling 500
hospitalized COVID-19 patients across Europe.
Mipasetamab Uzoptirine
Post period, ADC Therapeutics announced that the first patient was dosed in a
Phase 1 clinical trial evaluating mipasetamab uzoptirine as a single agent and
in combination with gemcitabine in patients with selected advanced solid tumors.
Mipasetamab uzoptirine contains an AXL-targeting humanized monoclonal antibody
licensed from BerGenBio.
Corporate Activities
BerGenBio strengthened its leadership team in April 2022 with the addition of
Cristina Oliva, M.D., as Chief Medical Officer. Dr. Oliva is a Board-certified
oncologist with over 20 years of senior clinical development experience across
large pharmaceutical, biotechnology and CROs, including her most recent position
as Vice President, Oncology and Head of Oncology Centre of Excellence at IQVIA,
Ltd.
Second Quarter 2022 Financial Highlights
(Figures in brackets = same period 2021 unless otherwise stated)
? Revenue amounted to NOK 0.0 million (NOK 0.0 million) for the second
quarter 2022
? Total operating expenses for the second quarter were NOK 88.2 million
(NOK 92.3 million)
? The operating loss for the second quarter came to NOK 88.2 million (NOK
92.3 million)
? Cash and cash equivalents amounted to NOK 292.1 million (NOK 367.8
million at the end of the first quarter 2022).
Presentation and Webcast Details
The live webcast link is available at www.bergenbio.com in the
Investors/Financial Reports section. A recording will be available shortly after
the webcast has finished.
Webcast link:
https://channel.royalcast.com/landingpage/hegnarmedia/20220823_9/ (https://eur03.
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Dial-in numbers:
NO: +47-21-956342
UK: +44-203-7696819
US: +1 646-787-0157
SE: +46-4-0682-0620
DK: +45 78768490
Pin: 712491
The first quarter report and presentation are available on the Company’s website
in the Investors/Financial Reports section and a recording of the webcast will
be made available shortly after the webcast has finished.
-End-
Contacts
Martin Olin CEO, BerGenBio ASA
ir@bergenbio.com
Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com
Investor Relations / Media Relations
Graham Morrell
graham.morrell@bergenbio.com
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 COVID-19.
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
