25 February 2025
BerGenBio ASA: BerGenBio announces discontinuation of 1L STK11M NSCLC study and exploration of strategic alternatives
Bergen, Norway, February 25, 2025 – BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing the novel, selective AXL kinase inhibitor bemcentinib for serious diseases today announced its decision to close its BGBC016 study of bemcentinib in combination with standard of care therapy in first line (1L) non-squamous Non-Small Cell Lung Cancer (NSCLC) patients with a mutation in the STK11 gene (STK11m).
“It is, of course, disappointing and unexpected that we are now discontinuing the study. I would like to extend my gratitude to the patients and investigators who participated in our study for this particularly difficult-to-treat patient group, as well as to our team members who have worked tirelessly on this effort”, stated Olav Hellebø, Chief Executive Officer of BerGenBio. “We do not believe these preliminary results are strong enough for the company to obtain additional funding within the current cash runway to complete the study as originally designed. The company is now entering a new phase in which strategic alternatives will be explored, which may include a potential sale, merger, or other strategic transaction.”
Background:
In 2024, the company announced the completion of enrollment in the Ph1b portion of the study which demonstrated acceptable safety in 1L NSCLC patients regardless of STK11 mutational status, as evaluated by an independent Data Safety Monitoring Board (DSMB). Early encouraging data were seen in three STK11m patients, including one patient who experienced a complete response and who remains in response and on treatment after nearly two years. The company, in agreement with the independent DSMB, determined that these initial results warranted the continuation of the study into the Ph2a portion.
In March 2024, the company initiated the Ph2a portion of the study designed to recruit 40 evaluable 1L STK11m NSCLC patients. The primary endpoint for the Ph2a was overall response rate (ORR). To determine the feasibility of obtaining near-term funding, the company performed a preliminary analysis of the responses in the 10 efficacy evaluable STK11m patients. While there was 1 response in the Ph1b we did not observe additional responses in the Ph2a patients. Consequently, the company has decided to discontinue the BGBC016 study.
The Board of Directors has now initiated an exploration of strategic alternatives. As part of this process, the board will consider a range of options for the company including, among other things, a potential sale, merger, or other strategic transaction. There can be no assurance that this exploration process will result in any transaction.
Contacts
Olav Hellebø, CEO BerGenBio ASA
Rune Skeie, CFO, BerGenBio ASA
Jan Lilleby, Investor Relations / Media Relations
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. 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.
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).
