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BerGenBio

Legal Proceedings Report Nov 6, 2023

3555_rns_2023-11-06_29c1438c-6c19-466d-b614-f9af3ab894df.html

Legal Proceedings Report

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BerGenBio Announces Data from Biomarker Analyses in 2L NSCLC

BerGenBio Announces Data from Biomarker Analyses in 2L NSCLC

Presented at 2023 SITC Meeting

- A pre-planned biomarker analysis of patients treated with bemcentinib in

combination with KEYTRUDA® (pembrolizumab) yields new understandings-

BERGEN, Norway, November 6, 2023 - BerGenBio ASA (OSE: BGBIO), a clinical-stage

biopharmaceutical company developing novel, selective AXL kinase inhibitors for

severe unmet medical needs, announced that a poster presentation detailing

additional data from a Phase II trial of bemcentinib in combination with MSD's

anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in second line Non-Small Cell Lung

Cancer (NSCLC) patients was presented on November 4th at the 2023 Society of

Immunotherapy of Cancer Annual Meeting.

The pre-planned biomarker analysis of the BGBC008 study in 2L NSCLC patients

adds to the clinical data recently announced at the 2023 ESMO meeting. The

poster presentation entitled "Bemcentinib + Pembrolizumab show promising

efficacy in metastatic NSCLC patients harboring mutations associated with poor

prognosis: exploratory sub-analysis from the BGBC008 Trial", is now available on

BerGenBio's website under the Scientific Publications section.

Martin Olin, Chief Executive Officer of BerGenBio, commented "The findings add

to the industry's understanding of the outcomes in 2L NSCLC patients and the

potential for bemcentinib to benefit patients in combination with immune

checkpoint inhibition. While the dataset in the analyses is relatively small, we

believe bemcentinib in combination with pembrolizumab has the potential to

improve outcomes in NSCLC patient sub-groups that have been associated with poor

survival, including patients with negative/low PD-L1 levels, STK11 mutations,

and KEAP1 mutations".

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of

Merck & Co., Inc., Rahway, NJ, USA

-End-

Contacts

Martin Olin CEO, BerGenBio ASA

[email protected]

Rune Skeie, CFO, BerGenBio ASA

[email protected]

Investor Relations / Media Relations

Jan Lilleby

[email protected]

About Bemcentinib

Bemcentinib is a potentially first-in-class, potent and highly selective

inhibitor of the tyrosine kinase AXL.  Extensive studies confirm the ability to

combine bemcentinib with immune checkpoint inhibitors, chemotherapies and

targeted therapies with the goal of improving a patient's immune response and

delaying the development of chemoresistance.  Bemcentinib is currently being

investigated in combination with immune checkpoint inhibition and chemotherapy

in first line NSCLC patients harboring mutations in the STK11 gene, a known

prognostic factor of poor response to existing therapies.

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 subject to the disclosure requirements pursuant to section 5

-12 of the Norwegian Securities Trading Act.

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