Bioasis Announces FDA Response to Pre-IND Submission
26 June 2019 - 6:05AM
Business Wire
Bioasis Technologies Inc. (TSX.V:BTI; OTCQB:BIOAF) (the
“Company” or “Bioasis”), a pre-clinical, research-stage
biopharmaceutical company developing its proprietary
xB3™ platform technology
for the delivery of therapeutics across the blood-brain barrier
(“BBB”) and the treatment of central nervous system (“CNS”)
disorders in areas of high unmet medical need, including brain
cancers and neurodegenerative diseases, today announced it had
received feedback to its pre-Investigational New Drug (”IND”)
submission to the U.S. Food and Drug Administration (“FDA”)
regarding the planned development of xB3-001, the Company’s lead
investigational candidate to treat brain cancer.
In May 2019, Bioasis submitted to the FDA its pre-IND briefing
document in support of the xB3-001 program for the treatment of
patients with confirmed human epidermal growth factor receptor 2
(“HER2”)-positive (“HER2+”) breast cancer and brain metastases.
“We are pleased to have completed the pre-IND process, with the
FDA providing helpful guidance for the continued advancement of
xB3-001 for the treatment of HER2+ human brain metastases, an
indication with an urgent and significant unmet medical need,” said
Deborah Rathjen, Ph.D., Company Chair and Chief Executive Officer.
“We appreciate the FDA’s feedback as we endeavor to treat HER2+
brain metastases utilizing our innovative and robust
blood-brain-barrier technology.”
The Company’s lead program, xB3-001, an xB3 peptide vector
trastuzumab fusion, is being readied for clinical testing for the
treatment of HER2+ breast cancer brain metastases. Preclinical
studies have demonstrated that xB3-001 can deliver an efficacious
level of trastuzumab to established HER2+ human breast cancer brain
metastases in a non-invasive manner, while trastuzumab alone had
minimal brain uptake and no impact on both the size and number of
brain tumors.
ABOUT BIOASIS Bioasis Technologies Inc. is a
biopharmaceutical company developing the xB3™ platform, a proprietary technology
for the delivery of therapeutics across the blood brain barrier 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 blood brain barrier 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 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.us.
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, along with
other 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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Deborah Rathjen, Ph.D. deborah@bioasis.us +1 203 533 7082
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