- Treatment of Syrian hamsters with TATX-03, a cocktail of four
proprietary monoclonal antibodies directed against distinct regions
of the SARS-CoV-2 spike protein, resulted in strong anti-viral
effects against SARS-CoV-2 in both protective and therapeutic
settings
- Therapeutic treatment of SARS-CoV-2 infected Syrian hamsters
cleared the lungs and throat of detectable replication-competent
virus in 100% of the SARS-CoV-2 infected hamsters
- Two of the three antibodies tested from the TATX-03 cocktail
are unaffected by SARS-CoV-2 variants of concern, including the
South African and UK variants
ImmunoPrecise Antibodies Ltd. (the "Company" or "IPA") (NASDAQ:
IPA) (TSX Venture: IPA) announced preliminary, preclinical data in
hamsters of IPA’s proprietary TATX-03 PolyTope antibody cocktail
program against SARS-CoV-2, the virus that causes COVID-19 disease.
In a preclinical study using a SARS-CoV-2 hamster model, treatment
with IPA’s TATX-03 resulted in complete clearance of detectable
replication-competent virus from the lungs and throat of SARS-CoV-2
infected animals.
The results of the preclinical study demonstrated the potential
of IPA’s TATX-03 antibody cocktail to provide strong anti-viral
effects against SARS-CoV-2 in both prophylactic (preventative) and
treatment settings. IPA’s TATX-03 cocktail is designed with the
goal of being both protective and curative for COVID-19 disease. In
addition, by incorporating multiple antibodies that recognize
different, non-overlapping epitopes on the SARS-CoV-2 spike
protein, IPA’s TATX-03 antibody cocktail has the potential to
prevent mutational escape, the process by which a virus, through
mutation, may render vaccines less efficacious.
TATX-03 was 100% efficacious in the preclinical hamster model
in treating SARS-CoV-2 infection in a therapeutic setting.
IPA’s TATX-03 PolyTope antibody cocktail was administered as a
single dose to hamsters that had been infected with the SARS-CoV-2
variant. The study showed that IPA’s antibody cocktail cleared the
lungs of detectable replication-competent virus in 100% of the
SARS-CoV-2 infected hamsters by day 4 post-infection. Furthermore,
the study showed undetectable levels of virus titer in the throat
of 100% of the infected hamsters 3 days after virus infection.
TATX-03 protected against SARS-CoV-2 infection in a
prophylactic setting. Administration of a single dose of IPA’s
TATX-03 PolyTope antibody cocktail twenty-four hours prior to
infecting hamsters with a SARS-CoV-2 variant resulted in the
reduction of replication-competent virus titer to undetectable
levels in the lungs of four out of five hamsters by day 4, with the
remaining animal showing virus levels barely above the lowest level
of detection.
Mutagenic escape risk reduction by IPA’s PolyTope
approach.
In developing IPA’s TATX-03, the Company enrolled their PolyTope
approach to facilitate cocktail formation of antibodies that
recognize non-overlapping SARS-CoV-2 spike protein epitopes to
improve the potential of its product to remain effective despite
multiple mutations of the virus. As treatment efficacy is not
solely dependent on one antibody, a combination therapy is expected
to be efficacious even if one of the components would be affected
by a particular virus mutation. In addition, the plug-and-play
character of IPA’s PolyTope approach is anticipated to allow quick
adaptation of treatment formulations, if required, leveraging their
diversified lead antibody pool containing multiple antibody
alternatives to each epitope represented in the cocktail. While
extensive mutant analysis is ongoing, IPA has confirmed that
interaction of two out of three tested antibodies from the TATX-03
cocktail with the S. African (B.1.351) and UK (B.1.1.7) SARS-CoV-2
spike protein variants is not compromised (the fourth was not
prioritized for testing as, based on computational analysis, it was
deemed unlikely to be impacted by the mutations). Twenty-seven
extensively characterized, potently neutralizing lead candidate
antibodies will be analyzed to generate full interaction profiles
against seventeen different SARS-CoV-2 variants, including the S.
African, Brazilian, UK and more prevalent single substitution
mutants SARS-CoV-2 spike protein variants. Data are expected to be
available early March.
“This important preclinical study shows that TATX-03 not only
protected against, but effectively treated, a high dose of
SARS-CoV-2 variant infection in hamsters, further supporting the
advancement of TATX-03,” stated Dr. Ilse Roodink, ImmunoPrecise’s
SARS-CoV-2 Global Program Director.
“Based on the positive data obtained to date, we remain
optimistic about TATX-03 and its potential to prevent and treat
COVID-19 disease,” added Dr. Jennifer Bath, CEO of ImmunoPrecise,
“including disease caused by SARS-CoV-2 variants, as was intended
in IPA’s original design of the cocktail. We are looking forward to
continuing to progress TATX-03 through the final stages of its
preclinical development.”
IPA intends to conduct what it anticipates will be the final
IND-enabling studies, including non-human primate, dose-dependent
evaluation of the TATX-03 antibody cocktail, in late Q2 2021,
resulting in what IPA anticipates will provide the final, necessary
preclinical data points to support the potential clinical
evaluation of TATX-03.
About IPA’s PolyTope Platform.
IPA’s SARS-CoV-2 PolyTope monoclonal therapies are designed to
protect against mutagenic escape with an emphasis on efficacy for
every patient, variant, and strain of SARS-CoV-2. They are created
with the goal of sustainable efficacy in the face of an evolving
virus, combining extensively characterized, potently neutralizing,
synergistic antibodies exhibiting richly diverse epitope
coverage.
About ImmunoPrecise Antibodies Ltd.
IPA is an innovation-driven, technology platform company that
supports its pharmaceutical and biotechnology company partners in
their quest to discover and develop novel, therapeutic antibodies
against all classes of disease targets. The Company aims to
transform the conventional, multi-vendor, product development model
by bringing innovative and high-throughput, data-driven
technologies to its partners, incorporating the advantages of
diverse antibody repertoires with the Company’s therapeutic
antibody discovery suite of technologies, to exploit antibodies of
broad epitope coverage, multiple antibody formats, valency and
size, and to discover antibodies against multiple/rare epitopes.
For further information, visit www.immunoprecise.com or contact
solutions@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
potential of IPA’s PolyTope monoclonal antibodies, including
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, or to retain efficacy
over time, or to have antibodies available to add to its PolyTope
antibody cocktail to respond to new virus variants. 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 developing its
PolyTope antibody cocktail or other vaccines or 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, 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 November 16, 2020
(which may be viewed on the Company’s profile at www.sedar.com) and
the Company’s Form 40-F dated December 28, 2020 (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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210219005110/en/
For investor information please contact: Frédéric Chabot Phone:
1-438-863-7071 Email: frederick@contactfinancial.com
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