18 April 2023
BerGenBio ASA: BerGenBio Presents Data on STK11 Loss of Function and AXL Activation at AACR
– 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 – 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 2nd 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 (https://www.bergenbio.com/investors/presentations/) portion of the Investors section.
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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, 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.
About Oncoinvent
Oncoinvent is developing Radspherin®, a receptor-independent alpha radiation therapy that leverages the unique anatomy of the abdominal cavity to destroy residual micrometastases using a single, highly localized dose of alpha radiation. The initial clinical focus is treatment of ovarian and colorectal cancer patients after surgical removal of the primary tumor and visible metastases in the peritoneum, the thin membrane lining the abdominal cavity and covering the abdominal organs.
This radiopharmaceutical is designed to prevent or delay recurrence in the peritoneal cavity, keeping patients disease-free for longer than the current standard of care and thereby also impacting overall survival. It is broadly applicable to any cancer that spreads to the peritoneum, e.g. ovarian, colorectal, and gastric cancers. Radspherin® stands out for its simplicity, excellent safety profile, and seamless integration into existing surgical workflows. Oncoinvent’s product is easy to use, avoids systemic delivery and significant toxicity. It is also differentiated in being simple to manufacture, scalable, and supply de-risked.
Data from two trials in ovarian (phase 1) and colorectal (phase 1/2a) cancers, are highly promising, showing an excellent safety profile and meaningful signals of efficacy. Interim data from an ongoing, randomized, controlled phase 2 ovarian cancer trial is expected in 2026. With cost-effective manufacturing, blockbuster potential, active pharma partnership momentum, plus strong endorsements from leading experts, Oncoinvent is built for scale and commercial success, and is set to become the new standard for post-surgical cancer care. The Company was founded by the originators of Algeta and Xofigo (acquired by Bayer).
