BerGenBio receives positive recommendation from independent

Data and Safety Monitoring Board to proceed without study modification

BERGEN, Norway, March 20, 2024 /PRNewswire/ -- BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, announced today it has initiated the Phase 2a portion of the BGBC016 clinical study of its selective AXL inhibitor bemcentinib in combination with standard of care therapy in first-line Non Small Cell Lung Cancer (NSCLC) patients harboring a STK11 mutation (STK11m).

The initiation of Phase 2a follows a positive recommendation by the independent Drug Safety Monitoring Board (DSMB) which evaluated the safety of the combination of bemcentinib with pembrolizumab (Keytruda^®) and doublet chemotherapy in first-line (1L) NSCLC patients enrolled in the Phase 1b portion of the study.

Patients with STK11m NSCLC have a significantly poorer response to current therapies, including immune checkpoint inhibitors, when compared with patients with wild-type (non-mutated) STK11. AXL plays a significant role in the survival and spread of cancer and STK11m NSCLC patients have a high expression of AXL suggesting that AXL is an important target to prevent disease progression and resistance to existing therapies. Bemcentinib's selective inhibition of AXL has been shown to improve the response to immune checkpoint inhibition in STK11m patient-derived preclinical models and in early clinical studies. There are currently no targeted therapies available for the STK11m NSCLC patient population, which represents up to 20% of 1L NSCLC patients.

Cristina Oliva, Chief Medical Officer of BerGenBio commented, "We are very pleased that no new safety signals have been identified and are encouraged by the recommendation of the DSMB to continue the study as planned. We have therefore, opened the Ph2a portion of the study with the goal of reporting initial efficacy data as the next step in validating the benefit of bemcentinib in combination with standard therapies in 1L NSCLC."

Martin Olin, Chief Executive Officer of BerGenBio added, "The high unmet medical need in 1L STK11m NSCLC patients is widely recognized. Bemcentinib represents a novel treatment modality which may significantly improve the outcome for patients, and we are pleased to have achieved this important milestone."

Contacts

Martin Olin CEO, BerGenBio ASA
ir@bergenbio.com

Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com

Investor Relations / Media Relations

Jan Lilleby
jl@lillebyfrisch.no

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 severe respiratory infections. 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 considered to be inside information pursuant to the EU Market Abuse Regulation and subject to the disclosure requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.

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