Business and Financial Review • May 4, 2022
Business and Financial Review
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BERGENBIO ANNOUNCES LAUNCH OF BUSINESS STRATEGY FOCUSED ON NSCLC AND COVID-19
· BerGenBio to focus on two key opportunities for its lead compound bemcentinib
· Strategic focus anchored in strong scientific rationale, supported by
dataset from over 600 patients demonstrating bemcentinib's biological and
clinical activity matched with significant unmet medical needs
Bergen, Norway,4 May 2022 - BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL inhibitors for severe
unmet medical needs, announces today an update on its business strategy.
BerGenBio will now focus on two key indications; 1st line non-small cell lung
cancer (NSCLC) and COVID-19, which the Company believes offer the optimal path
towards translating BerGenBio's strong scientific foundation into significant
value generation from marketed products to address unmet medical needs.
The opportunity
BerGenBio has for many years pioneered research into AXL inhibition, with its
lead development candidate bemcentinib showing clinical potential in oncology
and infectious disease. With over 600 patients dosed (approx. 400 in oncology
and approx. 200 in COVID-19), the Company has built a large dataset
demonstrating biological and clinical activity while simultaneously defining
dosing regimens to identify an appropriate balance of safety and efficacy.
The updated business strategy announced today builds on bemcentinib's mode of
action and data gathered from a broad clinical exploration to progress two
distinct opportunities with the potential to significantly improve the lives of
patients: NSCLC and COVID-19. Both indications show strong evidence of
bemcentinib activity, with the advantage of accumulation in target organs,
options for accelerated registration, compelling competitive advantages, and
both represent high unmet medical needs.
Martin Olin, Chief Executive Officer of BerGenBio, commented:"BerGenBio has been
at the forefront of understanding of AXL biology and, having pioneered this
area, we remain confident that selective AXL inhibition holds significant
potential as a transformative treatment modality for several serious diseases. A
rapidly evolving treatment landscape, with improved standards of care in areas
such as oncology requires BerGenBio to be nimble and identify specific
opportunities where we can address unmet needs in a competitive manner.
With this in mind we believe that by introducing a laser focus and rightsizing
the organization on two key areas where we see our pipeline has the greatest
impact, we are efficiently advancing BerGenBio's potential; building on our
strong scientific foundation to deliver new drugs to market resulting in better
outcomes for patients and the generation of significant value for our
shareholders."
NSCLC
Despite advances in treatment, lung cancer remains the leading cause of cancer
-related deaths throughout the world.Approximately 85% of lung cancers are
classified as NSCLC. BerGenBio is targeting 1st Line STK11 mutated Non-Squamous
NSCLC patients, an extremely large patient population with very limited response
to the standard of care treatments. STK11 is an important tumor suppressor gene
reported to confer immunotherapy resistance in NSCLC and is present in up to 20%
of NSCLC patients.
Pre-clinical and clinical studies have suggested a mechanism by which
bemcentinib may restore response to immune checkpoint inhibitor therapy and
enable the avoidance of chemoresistance in NSCLC patients harboring STK11
mutations, thus potentially offering a treatment option to those patients who
respond poorly to existing therapies. Data from the subset of STK11mutated
patients treated in the Company's BGB008 study in 2nd line NSCLC also provides
early indications of efficacy in this biomarker driven patient population.
The FDA has recognized that STK11 is currently a "non-actionable" mutation - one
that confers poor outcome and has no specific therapeutic approaches today and
have granted BerGenBio a Fast Track Designation for bemcentinib in this setting.
To date, bemcentinib is to the Company's knowledge the only selective AXL
inhibitor in development for patients with STK11 mutation. BerGenBio has a
strong proprietary position for treatment of this population and believes there
may be a potential for an accelerated approval pathway in this patient sub-set.
COVID-19
Despite the success of vaccines, there is still a large number of hospitalized
patients that remain in need of improved therapeutic options for COVID-19.
Research into bemcentinib's potential in hospitalized COVID-19 patients began in
2020, in response to the emergence of the pandemic, and based on the Company's
understanding of AXL's role in mediating aggressive diseases.
Recently, BerGenBio announced results from the Phase II sub-protocol of the
platform ACCORD2 study, which met its primary and key secondary endpoints, with
demonstrable efficacy in patients on top of current standard-of-care treatments
including remdesivir and corticosteroids. Further, bemcentinib has been selected
to be studied under the EUSolidAct platform trial through a sub-protocol
enrolling 500 patients across European sites. Given the ongoing need for new
treatment options for hospitalized COVID-19 patients, the novel mechanism of
action of bemcentinib (independent of the spike protein), along with potential
to confirm the ACCORD2 data in theEUSolidAct trial,the Company believes that
this could warrant Emergency Use Authorizations based on precedents.
The Company believes that the unique mechanism of action and properties of
bemcentinib positions it well as a novel treatment modality within severe
respiratory infections beyond COVID-19.
With a focused strategy and rightsized organization BerGenBio plans to unlock
significant potential value related to the two indications selected and define
the path to market.
An investor call will take place today at 1pm CEST (7am ET), full details below.
Web link: https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20220504_12
Dial-in details:
PIN Code: 712491
NO: +47-21-956342
UK: +44-203-7696819
US: +1 646-787-0157
SE: +46-4-0682-0620
DK: +45 78768490
Contacts:
For BerGenBio:
Martin Olin CEO, BerGenBio ASA
Rune Skeie, CFO, 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 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, 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 considered to be inside information pursuant to the EU
Market Abuse Regulation and is subject to the disclosure requirements pursuant
to section 5-12 of the Norwegian Securities Trading Act.
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