0RU5 Bergenbio Asa

• In addition to STK11 mutations, KEAP1m identified as being associated with STK11 loss of function
• STK11 loss of function correlated to AXL activation and poorer outcomes in NSCLC

BERGEN, Norway, April 18, 2023 /PRNewswire/ -- BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, today announced that it presented data linking AXL activation to STK11 loss of function in Non-Small Cell Lung Cancer (NSCLC) in an abstract titled, AXL as a Therapeutic Target in STK11 mutant NSCLC, at the American Association for Cancer Research (AACR) Annual Meeting 2023.

An analysis of tumors lacking STK11 function from BerGenBio's 2^nd line NSCLC trial (BGBC008) and publicly available datasets suggest that STK11 and KEAP1 mutations are transcriptionally similar and share a common signature for STK11 loss of function. Loss of function leading to inactivation of STK11 is found in approximately 30% of lung adenocarcinomas as a result of both mutational and non-mutational mechanisms. These tumors with inactivated STK11 are likely to promote AXL activation due to high levels of energetic and metabolic stress, resulting in a poorer prognosis in NSCLC.

AXL, a member of the TAM family of receptor tyrosine kinases, is expressed in over 80% of NSCLC tumors that demonstrate loss of STK11 function. AXL is activated in response to inflammation, hypoxia, cellular stress or drug treatment. AXL is expressed in both tumor cells, where it enhances survival and drug resistance, and in innate immune cells, such as dendritic cells and macrophages, where AXL drives immune suppression. BerGenBio's selective AXL inhibitor bemcentinib targets key survival and resistance mechanisms within the tumor and restores the anti-tumor characteristics of innate immune cells within the tumor microenvironment.

"There is accumulating evidence substantiating the importance of targeting AXL within the tumor and innate immune cells of the tumor microenvironment," said Nigel McCracken,Ph.D., Chief Scientific Officer of BerGenBio. "A loss of STK11 function due to STK11 or KEAP1 mutations is associated with a poorer prognosis, irrespective of treatment modality and represents a large subgroup of NSCLC patients with high unmet need. Our preclinical data and the clinical data from our Phase 2 trial evaluating bemcentinib in combination with pembrolizumab support targeting AXL in both STK11 and KEAP1 mutated NSCLC patients."

The abstract will be available on the Company's website in the Scientific Presentations portion of the Investors section.

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

Media Relations Norway:

Jan Lilleby
jl@lillebyfrisch.no
+47 90 55 16 98

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. 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.

The following files are available for download:

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SOURCE BerGenBio ASA