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Beskrivning

LandNorge
ListaOB Match
SektorHälsovård
IndustriBioteknik
BerGenBio är ett norskt onkologibolag. Idag bedriver bolaget forskning och utveckling av hämmande läkemedel för behandling av aggressiva cancertyper. Bolaget har utvecklat ett flertal produkter vars sammansättning ämnar blockera proteinet AXL, ett protein positivt relaterat med spridning av cancercellerna. Bolaget grundades under 2007 och har sitt huvudkontor i Bergen, Norge.
2022-10-11 07:00:17
- Study will assess bemcentinib in combination with current standard of care for
1st line NSCLC -

- Approximately 20% of NSCLC patients have STK11 mutations -

- First patient is expected to be dosed in 4Q22 -

BERGEN, Norway, October 11, 2022 - BerGenBio ASA (OSE: BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical needs, today announced the initiation of a Phase 1b/2a
trial evaluating bemcentinib in combination with the current standard of care,
checkpoint inhibitor pembrolizumab and doublet chemotherapy, for the treatment
of 1st line (1L) Non-Small Cell Lung Cancer (NSCLC) patients harboring STK11
mutations (STK11m).

"Real-world data continues to reinforce that the presence of STK11m currently
result in particularly poor outcomes for NSCLC patients," said Martin Olin,
Chief Executive Officer of BerGenBio. "We believe that bemcentinib's proficiency
in blocking AXL overexpression may result in the reversal of an
immunosuppressive tumor microenvironment leading to activation of immune
response, restoration of sensitivity to immune checkpoint therapy and
potentiation of chemotherapy effects in this large, underserved patient
population."

Bemcentinib, is a potent, first-in-class highly selective inhibitor of the
receptor tyrosine kinase AXL, which is overexpressed in response to cellular
stress, inflammation, hypoxia and chemotherapy. STK11 mutations are detected in
approximately 20% of non-squamous NSCLC patients and are known to create a more
immunosuppressive tumor microenvironment limiting the response to checkpoint
inhibition. Preclinical data have demonstrated that by selectively blocking AXL
activation, bemcentinib restores sensitivity to immune checkpoint inhibitor
therapy, enhances chemotherapy, while also, pertinently, driving the expansion
of CD8+ T cells in STK11m models. Early clinical data also point to the activity
of bemcentinib in NSCLC patients, including those harboring STK11m.

The global, open-label Phase 1b/2a trial is designed to determine the safety,
tolerability and efficacy of bemcentinib with standard of care in untreated
advanced/metastatic non-squamous NSCLC patients with STK11 mutations and no
actionable mutations. The Phase 1b portion of the study will evaluate the safety
and feasibility 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 part will assess the efficacy of
bemcentinib in the same treatment combination in 1L advanced/metastatic non
-squamous NSCLC patients with STK11 mutations. The first patient is expected to
begin treatment in the fourth quarter of 2022.

Contacts

For BerGenBio:

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

+1 781 686 9600

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 subject to the disclosure requirements pursuant to section 5
-12 of the Norwegian Securities Trading Act.