Bioasis Announces Publication of Independent Validation of the Company’s xB3 ™ Platform Technology
May 30 2018 - 08:30AM
Business Wire
Research Conducted by MedImmune Shows the
xB3 Platform Efficiently Delivers Antibodies Across
the BBB at Therapeutic Doses
xB3 Demonstrated Sustained
Systemic PK Properties of the MedImmune Antibody Constructs and
Demonstrated a Strong PK/PD Dose Dependent Relationship in a
Neuropathic Pain Pre-Clinical Model
The Research was Published in the
Journal of Cerebral Blood Flow and Metabolism1
BIOASIS TECHNOLOGIES INC. (TSX.V:BTI;
OTCQB:BIOAF), a biopharmaceutical company developing its xB3
TM proprietary platform technology for the delivery of therapeutics
across the blood-brain barrier (BBB) and the treatment of CNS
disorders in areas of high unmet medical-need, including brain
cancers and neurodegenerative diseases, today announced the
publication of independent research validating the ability of the
company’s xB3 platform to efficiently deliver antibodies across the
blood-brain barrier to the central nervous system in
therapeutically relevant doses.
Scientists at MedImmune, the global biologics research and
development arm of AstraZeneca, evaluated Bioasis’ xB3 platform
technology by making two xB3 antibody fusion proteins and measuring
systemic pharmacokinetic (PK) and brain exposure in mice; this was
followed by a pharmacodynamic (PD) study in a mouse neuropathic
pain model. This research shows that the xB3 platform demonstrated
a strong PK/PD dose dependent relationship in this pre-clinical
neuropathic pain mouse model without compromising peripheral
pharmacokinetic properties. The research conducted by Thom, et al.,
“A peptide derived from melanotransferrin delivers a protein-based
interleukin 1 receptor antagonist across the BBB and ameliorates
neuropathic pain in a pre-clinical model,” was published in the
Journal of Cerebral Blood Flow and Metabolism.
The study found that the xB3 fusion protein maintained the
systemic pharmacokinetics of its payload and had significantly
improved and sustained brain exposure of the payload molecule. The
PD study demonstrated dose dependent pre-clinical effect in
neuropathic pain model post single dose systemic
administration.
The data presented in this publication provide evidence for the
utility of xB3 peptides (previously known as MTfpep) as a platform
technology for delivery of recombinant and chemically conjugated
drugs across the BBB to increase brain exposure. The
pharmacokinetic data demonstrate efficient delivery of antibodies
across the BBB with peak exposure of over 4% injected dose per gram
of brain, compared to peak of 0.5% for payload alone.
The new data from MedImmune further highlights that xB3 peptides
do not affect systemic pharmacokinetics of the antibody payload
compared to the payload alone. In the pharmacodynamic mouse model
of neuropathic pain, the recombinant fusion protein with
interleukin-1 receptor antagonist (IL-1RA) demonstrated efficient
delivery of therapeutic concentrations of IL-1RA to the CNS and
eliciting analgesia in the animal model after a single dose
treatment. Systemic administration of IL-1RA itself does not elicit
analgesia.
“The results from this research independently validate the
utility of our xB3 platform technology to increase delivery of
therapeutic compounds across the blood-brain barrier at levels that
may help treat a variety of central nervous system diseases. The
Medimmune data are consistent with the previous antibody study
where our technology successfully delivered Herceptin®
(trastuzumab) to the brain, engaged the target areas and reduced
brain metastasis by 68%.” said Mei Mei Tian, Ph.D., vice president,
head of external research, Bioasis.
ABSTRACT
Delivery of biologic drugs across the blood-brain barrier is
becoming a reality. However, the solutions often involve the
assembly of complex multi-specific antibody molecules. Here we
utilize a simple 12 amino-acid peptide originating from the
melanotransferrin (MTf) protein that has shown improved brain
delivery properties. 3D confocal fluorescence microscopic analysis
demonstrated brain parenchymal localization of a fluorescently
labelled antibody (NIP228) when chemically conjugated to either the
MTf peptide or full-length MTf protein. Measurement of plasma
kinetics demonstrated the MTf peptide fusions had very similar
kinetics to an unmodified NIP228 control antibody, whereas the
fusion to MTf protein had significantly reduced plasma exposure
most likely due to a higher tissue distribution in the periphery.
Brain exposure for the MTf peptide fusions was significantly
increased for the duration of the study, exceeding that of the
fusions to full length MTf protein. Using a neuropathic pain model,
we have demonstrated that fusions to interleukin 1 receptor
antagonist (IL-1RA) are able to induce significant and durable
analgesia following peripheral administration. These data
demonstrate that recombinant and chemically conjugated MTf-based
brain delivery vectors can deliver therapeutic levels of drug to
the central nervous system.
About Bioasis
Bioasis Technologies, Inc. is a biopharmaceutical company
developing xB3, a proprietary platform technology for the delivery
of therapeutics across the blood-brain barrier (BBB) and the
treatment of CNS disorders in areas of high unmet medical need,
including brain cancers and neurodegenerative diseases. The
delivery of therapeutics across the BBB represents the final
frontier in treating neurological disorders. The in-house
development programs at Bioasis are designed to develop symptomatic
and disease-modifying treatments for brain-related diseases and
disorders. The company maintains headquarters in Richmond, Canada
with offices in Guilford, Conn., United States. Bioasis trades on
the TSX Venture Exchange under the symbol “BTI” and on the OTCQB
under the symbol “BIOAF.” For more information about the company
please visit www.bioasis.ca or www.bioasis.us.
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_______________________
1 Thom G, Tian MM, Hatcher JP, et al., A peptide derived from
melanotransferrin delivers a protein-based interleukin 1 receptor
antagonist across the BBB and ameliorates neuropathic pain in a
preclinical model. Journal of Cerebral Blood Flow and
Metabolism.
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