Vis børsmeldingen
continues on therapy in a trial assessing bemcentinib in recurrent glioblastoma
(GBM). The trial is sponsored by Prof. Ichiro Nakano, MD, Professor in the
Department of Neurosurgery and co-leader of the Neuro-Oncology Program at
University of Alabama at Birmingham and funded by the National Cancer Institute
(NCI).
This is an open label, multi-centre, intra-tumoral tissue pharmacokinetic (PK)
study of bemcentinib in patients with recurrent glioblastoma for whom a surgical
resection is medically indicated. The study will enrol up to 20 recurrent GBM
patients, at up to 15 sites in the USA. 10 patients will be treated prior to
surgery and 10 patients will have no pre-surgical treatment. However, all
patients will receive treatment with bemcentinib following surgery. The
endpoints of the study include an evaluation of bemcentinib’s ability to cross
the blood brain barrier, AXL expression, pharmacokinetics, safety and
tolerability, as well as efficacy assessments including Progression Free
Survival and Overall Survival. More information about the trial can be found at
https://clinicaltrials.gov/ct2/show/NCT03965494 (https://clinicaltrials.gov/ct2/s
how/NCT03965494)
Increased expression of the receptor tyrosine kinase AXL is significantly
correlated with poor prognosis in GBM patients and preclinical data has
suggested that bemcentinib may be a promising therapeutic agent for GBM,
particularly in post-irradiation mesenchymal-transformed GBM tumors[1]. A
comprehensive translational research programme will run in parallel with the
clinical trial, this will be conducted by Prof. Jeff Supko, Harvard Medical
School and Director of the Clinical Pharmacology Laboratory, Massachusetts
General Hospital (Boston, USA).
Prof. Burt Nabors MD, the Chairman of the trial and Director of Neuro-Oncology
at University of Alabama at Birmingham (UAB) and Director of UAB’s Centre for
Clinical Translational Science’s Clinical Research Unit, commented: “GBM is
among the most lethal of adult cancers. The median survival of patients remains
less than two years despite the current available therapies, including surgery,
radiation, and chemotherapy; development of more effective therapies is urgently
needed. We welcome the opportunity to offer patients access to the
investigational AXL inhibitor bemcentinib in this pilot study and look forward
to initiating additional trial sites across the Adult Brain Tumour Consortium in
the USA later this year.”
Richard Godfrey, Chief Executive Officer of BerGenBio, commented: “We
congratulate Prof. Nakano and Prof. Nabors on the start of this exciting
clinical study, which we believe will provide us with important data regarding
the ability of bemcentinib to cross the blood-brain barrier and potentially
treat GBM patients. This clinical trial is based on pioneering preclinical
research carried out by our collaborators, conducted at high profile research
hospitals in the USA and is funded by National Cancer Institute (NCI). We look
forward to reporting the potential of bemcentinib to improve patient outcomes in
this very aggressive cancer.”
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 immune-evasive and therapy resistant cancers. The
company’s proprietary lead candidate, bemcentinib, is a potentially first-in
-class selective AXL inhibitor in a broad Phase II oncology clinical development
programme focused on combination and single agent therapy in lung cancer,
leukaemia and COVID-19. A first-in-class functional blocking anti-AXL antibody,
tilvestamab, is undergoing Phase I clinical testing. In parallel, BerGenBio is
developing companion diagnostic tests to identify those patient populations most
likely to benefit from bemcentinib or tilvestamab: this is expected to
facilitate more efficient registration trials and support a precision medicine
-based commercialisation strategy. For further information, please visit:
www.bergenbio.com (http://www.bergenbio.com)
About Investigator-Sponsored Trials
Investigator-sponsored clinical trials are clinical trials proposed by front
-line patient-facing physicians who act as the regulatory sponsor and are
supported by industry in bespoke clinical development partnerships. The industry
partner does not assume the role of sponsor according to European or US
regulatory guidelines but may offer support in a variety of different ways, such
as providing investigational medicinal product at no cost.
About Glioblastoma
Glioblastoma (GBM) ranks among the deadliest of all human cancers with no
curative options available[2]. It is the most aggressive of the gliomas, a
collection of tumors arising from glia or their precursors within the central
nervous system. Gliomas are divided into four grades, grade 4 or glioblastoma
multiforme (GBM) is the most aggressive of these and is the most common in
humans. Most patients with GBMs die of their disease in less than a year[3].
For more information, please contact
Richard Godfrey
CEO, BerGenBio ASA
media@bergenbio.com
+47 917 86 304
International Media Relations
Mary-Jane Elliott, Chris Welsh, Carina Jurs,
Lucy Featherstone, Maya Bennison
Consilium Strategic Communications
bergenbio@consilium-comms.com
+44 7780 600290
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.
[1] 3. Sadahiro H, Kang KD, Gibson JT, et al. Activation of the Receptor
Tyrosine Kinase AXL Regulates the Immune Microenvironment in Glioblastoma.
Cancer Res. 2018;78(11):3002-3013.
[2,3] 3 1. Cloughesy, T., Finocchiaro, G., Belda-Iniesta, C., et al. (2016).
Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase II Study of
Onartuzumab plus Bevacizumab versus Placebo plus Bevacizumab in Patients with
Recurrent Glioblastoma: Efficacy, Safety, and Hepatocyte Growth Factor and O6
-Methylguanine-DNA Methyltransferase Biomarker Analyses. J Clin Oncol,
JCO2015647685. Gilbert, M.R., Sulman, E.P., and Mehta, M.P. (2014). Bevacizumab
for newly diagnosed glioblastoma. N Engl J Med 370, 2048-2049.
Kilde
