Bioasis & BioAgilytix Announce Strategic Collaboration to Advance xB3 TM-001, Bioasis’ Lead Investigational Candidate to Tr...
July 11 2018 - 8:00AM
Business Wire
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, and BIOAGILYTIX, a leading provider of contract
bioanalytical testing services with specialization in large
molecule bioanalysis, today announced a strategic collaboration to
partner on the development and validation of bioanalytical methods
to support and advance the xB3 TM-001 program, Bioasis’ lead
candidate to treat HER2+ brain cancer, to investigational new drug
(IND) submission and into the clinic. The development and
validation of bioanalytical methods are critical to ensuring the
highest quality data to support regulatory approval of the IND and
clinical pharmacokinetic data that will allow the Company to define
the clinical dose for the program to ensure maximum therapeutic
benefit for patients in Phase 1 and beyond.
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“BioAgilytix is a globally-respected leader in immunoassays, and
we are tremendously pleased to be working with them on our
bioanalytical method development and validation across a number of
parameters to support the IND submission and Phase 1 clinical trial
for our lead program in HER2+ brain cancer,” said Mark Day, Ph.D.,
president and chief executive officer, Bioasis. “BioAgilytix’s
expertise and experience in large molecule bioanalysis as well as
expertise with trastuzumab analytics will be instrumental to
advancing this program.”
“We are excited to be working with Bioasis to advance their lead
program in HER2+ brain cancer with the xB3 platform technology. We
support Bioasis’ mission to aggressively advance this program to
bring innovative treatments to patients with brain cancer,” said
Jim Datin, president and chief executive officer, BioAgilytix. “We
are committed to applying our superior science and expert
capabilities – which cover every phase of development, from
discovery to global Phase III trials – to achieve Bioasis’
deliverables and timeline, adhering to high quality standards and
working collaboratively together as a strategic partner and problem
solver.”
Through this partnership, Bioasis will have access to
BioAgilytix’s extensive bioanalytical expertise, particularly in
ligand binding assays, anti-drug antibody detection, stability
assessments across complex matrices and highest quality GLP
validation of complex assays. BioAgilytix will ensure that Bioasis
will be able to generate high quality, reproducible data that will
help deliver needed medicines for patients suffering from brain
cancer.
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.
About BioAgilytix
BioAgilytix is a leading bioanalytical testing laboratory
specializing in large molecule bioanalysis. With laboratory
locations in North Carolina’s Research Triangle area and Hamburg,
Germany, BioAgilytix provides PK, immunogenicity, biomarkers, and
cell-based assay services supporting the development and release
testing of biologics across a number of industries and disease
states. BioAgilytix offers assay development, validation, and
sample analysis under non-GLP, GLP, and GCP, as well as GMP quality
control testing (i.e., product release testing, stability testing,
etc.).
BioAgilytix’s team of highly experienced scientific and QA
professionals ensures high quality science, data integrity, and
regulatory compliance through all phases of clinical development,
and is a trusted partner to many of the top global pharmaceutical
and biotech companies. For more information,
visit www.bioagilytix.com.
Forward Looking Statements
Certain statements in this press release contain forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995 or forward-looking information under applicable
Canadian securities legislation that may not be based on historical
fact, including without limitation statements containing the words
“believe”, “may”, “plan”, “will”, “estimate”, “continue”,
“anticipate”, “intend”, “expect” and similar expressions. Such
forward-looking statements or information involve known and unknown
risks, uncertainties and other factors that may cause our actual
results, events or developments, or industry results, to be
materially different from any future results, events or
developments express or implied by such forward-looking statements
or information. Such factors include, among others, our stage of
development, lack of any product revenues, additional capital
requirements, risk associated with the completion of clinical
trials and obtaining regulatory approval to market our products,
the ability to protect our intellectual property, dependence on
collaborative partners and the prospects for negotiating additional
corporate collaborations or licensing arrangements and their
timing. Specifically, certain risks and uncertainties that could
cause such actual events or results expressed or implied by such
forward-looking statements and information to differ materially
from any future events or results expressed or implied by such
statements and information include, but are not limited to, the
risks and uncertainties that: products that we develop may not
succeed in preclinical or clinical trials, or future products in
our targeted corporate objectives; our future operating results are
uncertain and likely to fluctuate; we may not be able to raise
additional capital; we may not be successful in establishing
additional corporate collaborations or licensing arrangements; we
may not be able to establish marketing and the costs of launching
our products may be greater than anticipated; we have no experience
in commercial manufacturing; we may face unknown risks related to
intellectual property matters; we face increased competition from
pharmaceutical and biotechnology companies; and other factors as
described in detail in our filings with the Canadian securities
regulatory authorities at www.sedar.com. Given these risks and
uncertainties, you are cautioned not to place undue reliance on
such forward-looking statements and information, which are
qualified in their entirety by this cautionary statement. All
forward-looking statements and information made herein are based on
our current expectations and we undertake no obligation to revise
or update such forward- looking statements and information to
reflect subsequent events or circumstances, except as required by
law.
“Neither the TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.”
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Media & Investor
RelationsFor Bioasis Technologies Inc.Catherine
London, +1 917-763-2709Catherine@bioasis.usorFor
BioAgilytixVovéo Marketing GroupCarla Nieser, +1 610-240-0400,
ext. 118c.nieser@voveo.com
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