9 March 2023
BerGenBio ASA: BerGenBio Announces First Patient Dosed in Phase 1b/2a Trial Evaluating Bemcentinib in 1st Line Non-Small Cell Lung Cancer with STK11 Mutations
– Global trial designed to study the safety, tolerability and efficacy of bemcentinib in combination with current standard of care –
BERGEN, Norway, March 9, 2023 – BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, today announced the first patient was dosed in a Phase 1b/2a trial evaluating bemcentinib in combination with the current standard of care, immune checkpoint inhibitor pembrolizumab and doublet chemotherapy, for the treatment of 1st line (1L) Non-Small Cell Lung Cancer (NSCLC) patients harboring STK11 mutations (STK11m).
“Approximately 20% of non-squamous NSCLC patients harbor STK11m and do not currently have effective treatment options,” said Martin Olin, Chief Executive Officer of BerGenBio. “One specific attribute of this group is that they almost all demonstrate high levels of AXL activation. We are elated to have dosed the first patient in our trial and to continue our evaluation of bemcentinib and its ability to inhibit AXL to revive STK11m NSCLC patients’ response to checkpoint inhibitors and chemotherapy.”
The trial’s lead investigator, Rajwanth Veluswamy, M.D., MSCR, Assistant Professor of Medicine, Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai (New York, NY), commented, “Today, STK11 mutations are correlated with a very poor prognosis for patients suffering from NSCLC. These mutations are widely recognized for their ability to impede the activity of anti-PD-1/L1 therapy. My colleagues and I are driven to find a better outcome for this large patient population and are eager to assess bemcentinib’s potential in achieving this goal.”
The global, open-label Phase 1b/2a trial is designed to determine the safety, tolerability and efficacy of bemcentinib with standard of care treatments in untreated advanced/metastatic non-squamous NSCLC patients with STK11 mutations and no actionable mutations. The Phase 1b portion of the study will evaluate the safety and feasibility of bemcentinib in combination with pembrolizumab and doublet chemotherapy in 1L advanced/metastatic non-squamous NSCLC patients, regardless of STK11 status. The Phase 2a expansion part will assess the efficacy of bemcentinib in the same treatment combination in 1L advanced/metastatic non-squamous NSCLC patients with STK11 mutations.
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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. The Company is focused on advancing its lead candidate, bemcentinib, a potentially first-in-class, oral, selective AXL inhibitor in STK11 mutated NSCLC and severe respiratory infections including 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.
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).
