IPA Updates on Investigational New Drug (IND) Enabling
Program for PolyTope® TATX-03
In vivo, IND enabling evaluations of PolyTope®
TATX-03 in animal model show:
-
There were no
pharmacokinetic aberrations
-
Injection with
TATX-03 is well tolerated - with a significant safety margin and no
clinical signs of toxicity
-
Maximum
tolerated dose study evaluating up to a 12.5-fold higher amount
than the highest dose anticipated for use in humans did not uncover
any observable clinical signs of toxicity
VICTORIA, BRITISH COLUMBIA (CANADA) -- InvestorsHub NewsWire
-- March 09, 2022 - IPA (IMMUNOPRECISE ANTIBODIES LTD.) (the
"Company") (NASDAQ: IPA) (TSXV: IPA) is pleased to report on the latest progress in
the development of their PolyTope® TATX-03 antibody cocktail
therapy with a proven strong efficacy against all tested SARS-CoV-2
variants-of-concern. The Company reports positive data indicating
their recent IND-enabling animal studies do not show any observable
acute adverse events, data which supports a highly positive safety
profile for TATX-03 as a clinical product. In addition, results
from the FDA reviewed and recommended animal study protocols
demonstrate that the in
vivo pharmacokinetic profiles of the individual
antibodies show no aberrations, and each antibody demonstrates a
characteristic human IgG1 pharmacokinetic profile.
As a prelude to a formal toxicology study, a maximum
tolerated dose and a pharmacokinetic study were completed using
injections of up to 12.5 times the anticipated highest dose
proposed for the phase 1 clinical trial. The results did not
demonstrate any adverse clinical signs, nor any observable effect
in behavior, change in appetite, or change in weight, in any of the
animals. In addition, monitored vitality indicators, such as body
temperature, stayed within their respective physiological ranges,
and no post-mortem
macroscopic tissue anomalies were observed.
In vivo animal serum
profiles of each antibody were in full accordance with those
expected for human immunoglobulins.
To promote IND approval and a seamless transition to the
clinic, the company engages in on-going communications with the FDA
regarding the TATX-03 data package. The FDA has advised to enhance
the preclinical safety evaluation by examining the build-up of
antibody serum concentrations in the laboratory animal model versus
humans, recommending a study design adaptation to increase the
number of injections and to monitor the elimination of antibodies
from the animals. The ongoing final GLP toxicology study is
therefore extended by eight weeks with the final data being
available mid-June, 2022. These current advancements allow
scheduling of Investigational New Drug (IND) filing to the FDA
early Q3. Importantly, the timelines for completion of clinical
batch production nor the launch of the intended phase 1 clinical
trial are not impacted and on schedule as planned.
"The lack of any adverse event, of morbidity, of mortality,
of any
observable effect in any of the rodents injected with an
order more of the highest intended clinical dose of TATX-03, is
very encouraging and supports that we have developed a very
efficacious and resilient SARS-CoV-2 therapy with an expectedly
high safety profile", stated Dr. Ilse Roodink, CSO of
IPA.
"Although we are awaiting the outcome of the final GLP
toxicology study, all signs indicate that we have designed a safe
and effective pharmaceutical", added Dr. Roodink. "We are eager to
proceed quickly but carefully to the first clinical trial phase as
soon as the TATX-03 drug product is ready for
distribution."
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 — dynamic scientists and business advisors — to
optimize antibody discovery and development, against rare and/or
challenging epitopes. For further information, visit
www.immunoprecise.com.
Investor contact:
LifeSci Advisors
John Mullaly
Email: jmullaly@lifesciadvisors.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-IND
studies, the ability of the Company to successfully submit an IND
application with respect to PolyTope® TATX-03, statements regarding
regulatory approvals, statements regarding the potential of IPA's
PolyTope® monoclonal antibodies, including TATX-03, to promote
antibody-mediated clearance, 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). 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 completing
its pre-IND studies or submitting an IND application to the FDA,
developing its PolyTope® monoclonal antibodies, including TATX-03,
or other therapeutics against COVID-19 through the successful and
timely completion of preclinical assays, studies and clinical
trials, or may not receive all regulatory approvals to commence and
then continue clinical trials of its products, including PolyTope®
TATX-03 and, be successful in partnering or commercializing its
products related to COVID-19, the coverage and applicability of the
Company's intellectual property rights to its PolyTope® antibody
cocktails, 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).
Furthermore, there can be no assurance that the pending patent
applications will issue as patents and that challenges will not be
instituted against the validity or enforceability of such patents.
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