BERGEN, Norway, July 20, 2020 /PRNewswire/ -- BerGenBio
ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company
developing novel, selective AXL kinase inhibitors for severe unmet
medical need, announces that the first patient has been dosed and
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
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
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] 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.
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