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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.
2021-03-12 07:00:09
Bergen, Norway, 12 March 2021 - BerGenBio ASA (OSE:BGBIO), a clinical-stage
biopharmaceutical company developing novel, selective AXL kinase inhibitors for
severe unmet medical need, is pleased to announce that it has completed
enrolment into Cohort C1 of its Phase II study (BGBC008) of bemcentinib in
combination with anti-PD-1 therapy Keytruda[®] (pembrolizumab) in refractory non
-small cell lung cancer (NSCLC) patients.

The BGBC008 trial ClinicalTrials.gov Identifier: NCT03184571 is being conducted
in three cohorts evaluating the safety and benefit of bemcentinib and
pembrolizumab combination in refractory NSCLC patients. Cohort C is assessing
second line patients refractory to first line treatment with checkpoint
inhibitors in combination with chemotherapy. A total of 13 patients have been
enrolled in Cohort C1 and the first efficacy data is expected within 24 weeks.
If successful the trial will expand to Cohort C2, assessing a further 29
patients.

The study is being sponsored by BerGenBio in collaboration with MSD, a tradename
of Merck & Co., Inc., Kenilworth, New Jersey, USA, who continue to supply
Keytruda[®] (pembrolizumab) for use in the study, under a collaboration
agreement signed in March 2017.

Richard Godfrey, Chief Executive Officer of BerGenBio, commented: "We are
pleased to have completed enrolment into the first stage of the third cohort
planned for this study. We are excited by the potential patient benefit of
selective AXL inhibition with bemcentinib, to reverse acquired resistance to
immune checkpoint inhibitors in cAXL-positive patients who have relapsed on
immunotherapy and chemotherapy. There are currently limited treatment options
for patients for whom first line therapies in NSCLC have been ineffective. If
successful, this combination treatment could provide an important alternative to
second line chemotherapy standard-of-care. I look forward to providing an update
on the data from this cohort in due course."

-End-

About AXL

AXL kinase is a cell membrane receptor and an essential mediator of the
biological mechanisms underlying life-threatening diseases.

In COVID-19, AXL has two synergistic mechanisms of action, it acts a co-receptor
to ACE2, to which the spike protein of the SARS-CoV-2 virus attaches and enters
the host cell, and AXL expression is upregulated that leads to suppression of
the Type 1 Interferon immune response by host cells and in their environment.
Research data confirms bemcentinib inhibits SARS-CoV-2 host cell entry and
promotes the anti-viral Type I interferon response.

In cancer, increase in AXL expression has been linked to key mechanisms of drug
resistance and immune escape by tumour cells, leading to aggressive metastatic
cancers. AXL suppresses the body's immune response to tumours and drives
treatment failure across many cancers. High AXL expression defines a very poor
prognosis subgroup in most cancers. AXL inhibitors, such as bemcentinib,
therefore, have potential high value as monotherapy and as the cornerstone of
cancer combination therapy, addressing significant unmet medical needs and
multiple high-value market opportunities.

Research has also shown that AXL mediates other aggressive diseases including
fibrosis.

About Bemcentinib

Bemcentinib (formerly known as BGB324), is a potential first-in-class, potent
and highly selective AXL inhibitor, currently in a broad phase II clinical
development programme. It is administered as an oral capsule and taken once per
day. Ongoing clinical trials are investigating bemcentinib in COVID-19, and
multiple solid and haematological tumours, in combination with current and
emerging therapies (including immunotherapies, targeted therapies and
chemotherapy), and as a single agent. Bemcentinib targets and binds to the
intracellular catalytic kinase domain of AXL receptor tyrosine kinase and
inhibits its activity.

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 immune-evasive, therapy resistant cancers. The
company's proprietary lead candidate, bemcentinib, is a potentially first-in
-class selective AXL inhibitor in a broad phase II clinical development
programme focused on combination and single agent therapy in cancer, leukaemia
and COVID-19. A first-in-class functional blocking anti-AXL
antibody, tilvestamab, is undergoing phase I clinical testing. In
parallel, BerGenBio is developing a companion diagnostic test to identify
patient populations most likely to benefit from AXL inhibition: this is expected
to facilitate more efficient registration trials supporting a precision medicine
-based commercialisation strategy.

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

Contacts

ir@bergenbio.com

Richard Godfrey CEO, BerGenBio ASA

Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com
+47 917 86 513

International Media Relations

Mary-Jane Elliott, Chris Welsh, Lucy Featherstone, Carina Jurs

Consilium Strategic Communications
bergenbio@consilium-comms.com
+44 20 3709 5700

Media Relations in Norway

Jan Petter Stiff, Crux Advisers

stiff@crux.no
+47 995 13 891

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.