5 June 2023
BerGenBio ASA: BerGenBio Announces Data from Bemcentinib Trial in Mesothelioma Presented at ASCO
– Investigator-led Phase IIa study met its primary endpoint of disease control rate at 12 weeks –
BERGEN, Norway, June 5, 2023 – BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, announced that an oral presentation detailing the initial results from a Phase IIa trial evaluating bemcentinib in patients with mesothelioma was presented today at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.
The abstract, Bemcentinib and pembrolizumab in patients with relapsed mesothelioma: MiST3, a phase IIa trial with cellular and molecular correlates of efficacy, was presented by the study lead investigator, Dr. Matthew Krebs, Ph.D., FRCP, The University of Manchester, UK. MiST, the Mesothelioma Stratified Therapy umbrella trial, led by Professor Dean Fennell at the University of Leicester, UK, is a British Lung Foundation funded study dedicated to improving survival outcomes for patients with mesothelioma. MiST3, the third arm of the trial, was designed to assess the efficacy of AXL/PD-1 inhibition with the combination of BerGenBio’s AXL inhibitor bemcentinib and pembrolizumab.
26 patients with relapsed mesothelioma were enrolled in MiST3 and all received at least one dose of bemcentinib and pembrolizumab. The primary endpoint of disease control rate at 12 weeks (DCR12w) was met: 46.2% (90% CI: 29.2, 63.4). Secondary endpoints included a disease control rate at 24 weeks (DCR24w) of 38.5% (95% CI: 20.2, 59.4) and an overall response rate of (ORR) of 15.4% (95% CI: 4.4, 34.9). The combination of bemcentinib and pembrolizumab was generally safe and well-tolerated.
Dr. Matt Krebs remarked, “We are encouraged by the initial results of the MiST3 trial and believe that this combination warrants further evaluation in patients with relapsed/refractory mesothelioma. While standard PD-1 targeting immunotherapies alone have helped some, the majority of patients are in need of better options. Data continues to point towards AXL inhibition being synergistic with PD-1 inhibition and that it has the potential to add significant benefit to this population.”
“We are quite pleased with the findings and thankful for all of the collaborators in the MiST3 trial,” Martin Olin, Chief Executive Officer of BerGenBio. “These results provide additional evidence of the role of bemcentinib’s AXL inhibition in another aggressive disease such as mesothelioma.”
-End-
Contacts
Martin Olin CEO, BerGenBio ASA
ir@bergenbio.com
Rune Skeie, CFO, BerGenBio ASA
rune.skeie@bergenbio.com
Media Relations
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 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, visitwww.bergenbio.com
About the University of Leicester
The University of Leicester is led by discovery and innovation – an international centre for excellence renowned for research, teaching and broadening access to higher education. It is among the Top 30 universities in the Times Higher Education (THE)’s Research Excellence Framework (REF) 2021 rankings with 89% of research assessed as world-leading or internationally excellent, with wide-ranging impacts on society, health, culture, and the environment. The University is home to more than 20,000 students and approximately 4,000 staff.
About The University of Manchester
The University of Manchester is recognised globally for its pioneering research, outstanding teaching and learning, and commitment to social responsibility. The Russell Group institution is ranked the 6th best university in the UK and 38th in the world (Academic Ranking of World Universities).
A truly international university, its community includes more than 44,000 students, 12,000 staff, and 500,000 alumni from 190 countries. Together, they are tackling the world’s biggest challenges – the University’s social and environmental impact is ranked in the top ten globally (Times Higher Education Impact Rankings).
The University is a powerhouse of research and discovery; 25 Nobel laureates are among its former staff and students; and it was ranked fifth for research power – the quality and scale of research and impact – in the UK government’s Research Excellence Framework (REF) 2021.
The institution is the most popular in the UK for undergraduate applications (UCAS 2021 cycle), and it is the most targeted university by the UK’s leading employers (The Graduate Market, 2023).
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).
