Histopathology Data of Preclinical Repeated Dose Toxicity Study and ex vivo Human Tissue Cross-Reactivity (TCR) Analysis Support Safety of IPA’s PolyTope® TATX-03, a Synergistic Antibody Cocktail against SARS‑CoV‑2
12 July 2022 - 10:04PM
Business Wire
Milestone IPA Toxicity Study Supports the
Safety of PolyTope® TATX-03 Antibody Cocktail Against COVID-19
IND-enabling safety evaluations of PolyTope®
TATX-03, executed under Good Laboratory Practice (GLP) standards
and regulatory guidelines, revealed no in vivo adverse effects
during histopathological examination nor any undesirable off-target
binding to human biomaterials.
IPA (IMMUNOPRECISE ANTIBODIES LTD.) (the “Company” or “IPA”)
(NASDAQ: IPA) (TSXV: IPA), an advanced biotherapeutic research and
technology company, reports the critical third-party findings of
two IND-enabling pre-clinical safety studies, de-risking the
clinical development of the Company’s PolyTope® TATX-03 antibody
cocktail and its potential to prevent and treat COVID-19. A summary
of the positive findings indicates that, through ex vivo
screenings, no non-specific binding of TATX-03 components to human
tissues was identified. In addition, an extended pre-clinical in
vivo toxicology study did not reveal any tissue or organ changes
following exposure to the antibody cocktail, even when administered
at over three times the highest anticipated dose in humans. In the
current landscape of “not if, but when” people will contract
COVID-19, the debilitating post-COVID “long-haul” effects, and the
ongoing life-threatening risks for immunocompromised individuals,
this long-awaited safety data illustrates the company’s reputation
for uncompromising scientific standards and dedication to
sustainable biotherapeutic solutions.
The toxicology study was carried out under regulatory-compliant
GLP conditions with animals receiving three intravenous injections
at one-week intervals with either PolyTope® TATX-03 or placebo. No
mortality was observed and, importantly, no macro- or microscopic
morphological or histopathological impact was detected on any of
the examined organs and tissues even after an extended observation
period, as recommended by the FDA.
In parallel, a full tissue cross-reactivity (TCR) study was
performed according to regulatory guidelines and involved
colorimetric immunohistochemical analysis of 37 tissue and blood
materials from five unrelated humans to cover a broad array of
various human tissues, organs and expressed proteins. These
screenings did not show cross-reactivity of the individual TATX-03
antibodies, an outcome that supports the specificity of the
antibodies to its intended target and suggests that no unintended
binding is expected in humans.
The toxicology and TCR study results are in line and compliant
with the outcomes and conclusions from the previous in vivo
pharmacokinetic study, and the dose-escalation study as reported in
the Company’s March 9, 2022, news release. The positive results
reported here will be included in the regulatory filing for
approval of clinical studies in humans.
“This is another significant milestone for
IPA and a leading contribution in efforts to protect against the
present and future threat that COVID-19 and its variants still
pose. These data support the safety of TATX-03 on top of its
already demonstrated, and we believe, unprecedented, resilience,
reflected by its potency to neutralize all SARS-CoV-2 variants of
concern tested so far,” stated Dr. Ilse Roodink, CSO of IPA. “We
are confident about the next steps in the program and are compiling
the data for sharing with the health authorities for clinical
approval,” she continued, “these excellent data readouts on safety
and pharmacokinetics tremendously support our ambition to start the
first-in-human clinical phase trial which is expected to commence
later this year.”
ImmunoPrecise Antibodies Ltd.
ImmunoPrecise Antibodies Ltd. is a biotherapeutic,
innovation-powered company that supports its business partners in
their quest to discover and develop novel antibodies against a
broad range of target classes and diseases. The Company offers a
hybrid of services and programs with advanced platforms and
technologies to optimize antibody discovery and development,
against rare and/or challenging epitopes. For further information,
visit www.immunoprecise.com.
Forward Looking Information
This news release contains forward-looking statements within the
meaning of applicable United States securities laws and Canadian
securities laws. Forward-looking statements are often identified by
the use of words such as “potential”, “plans”, “expects” or “does
not expect”, “is expected”, “estimates”, “intends”, “anticipates”
or “does not anticipate”, or “believes”, or variations of such
words and phrases or state that certain actions, events or results
“may”, “could”, “would”, “might” or “will” be taken, occur or be
achieved. Forward-looking information contained in this news
release include, but are not limited to, statements regarding the
Company’s ability to complete its pre-regulatory approval studies,
the ability of the Company to successfully submit a clinical use
application with respect to PolyTope® TATX-03, statements regarding
regulatory approvals, statements regarding the potential of IPA’s
PolyTope® TATX-03 to provide strong anti-viral effects against
SARS-CoV-2/COVID-19 disease or any variant of the virus as either a
prophylactic (preventative) or treatment (therapeutic), or to
retain efficacy over time, and statements regarding the
commencement date of first-in-human clinical phase trial. In
respect of the forward-looking information contained herein, the
Company has provided such statements and information in reliance on
certain assumptions that management believed to be reasonable at
the time.
Forward-looking information involves known and unknown risks,
uncertainties and other factors which may cause the actual results,
performance or achievements stated herein to be materially
different from any future results, performance or achievements
expressed or implied by the forward-looking information. Actual
results could differ materially from those currently anticipated
due to a number of factors and risks, including, without
limitation, the Company may not be successful in timely submission
of an application for regulatory approval, developing its PolyTope®
TATX-03 through the successful and timely completion of clinical
trials, or may not receive all regulatory approvals to commence and
then continue clinical trials of PolyTope® TATX-03, as well as
those risks discussed in the Company’s Annual Information Form
dated July 27, 2021 (which may be viewed on the Company’s profile
at www.sedar.com) and the Company’s Form 40-F, Amendment No, 1
dated September 28, 2021 (which may be viewed on the Company’s
profile at www.sec.gov). Should one or more of these risks or
uncertainties materialize, or should assumptions underlying the
forward-looking statements prove incorrect, actual results,
performance, or achievements may vary materially from those
expressed or implied by the forward-looking statements contained in
this news release. Accordingly, readers should not place undue
reliance on forward-looking information contained in this news
release.
The forward-looking statements contained in this news release
are made as of the date of this release and, accordingly, are
subject to change after such date. The Company does not assume any
obligation to update or revise any forward-looking statements,
whether written or oral, that may be made from time to time by us
or on our behalf, except as required by applicable law.
Neither the TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in policies of the TSX Venture
Exchange) accepts responsibility for the adequacy or accuracy of
this release.
SOURCE ImmunoPrecise Antibodies
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version on businesswire.com: https://www.businesswire.com/news/home/20220712005717/en/
Investor contact: investors@immunoprecise.com
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