IPA Toxicity Study Confirms Safety of PolyTope® TATX-03 Antibody Cocktail Against COVID-19
Safety assessments of the PolyTope® TATX-03 allowing a request for DNR, carried out in compliance with the standards of good laboratory practice (GLP) and regulatory guidelines, revealed no adverse effects in vivo during histopathological examinations, nor any adverse off-target binding to human biomaterials.
Histopathological data from the preclinical repeated-dose toxicity study and analysis ex-vivo of human tissue cross-reactivity confirm the safety of IPA’s PolyTope® TATX-03, a synergistic antibody cocktail against SARS-CoV-2
IPA (IMMUNOPRECISE ANTIBODIES LTD.) (the “Company” or “IPA”) (NASDAQ: IPA) (TSXV: IPA), a leading biotherapeutic research and technology company, announces key third-party results in the framework of two preclinical safety studies allowing a request for DNR, thus reducing the risks linked to the clinical development of the Company’s PolyTope® TATX-03 antibody cocktail and its possibilities to prevent and treat COVID-19. A summary of the positive results indicates that, thanks to the tests ex-vivo, no non-specific binding of TATX-03 components to human tissues has been identified. In addition, a preclinical toxicological study live showed no tissue or organ changes after exposure to the antibody cocktail, even when administered at more than three times the highest expected human dose. In today’s environment where the question is ‘not if, but when’ will people get infected with COVID-19, or feel the debilitating ‘long-term’ post-COVID effects that put people at life-threatening risk? immunocompromised patients, these long-awaited safety data underpin the Company’s reputation for uncompromising scientific standards and dedication to sustainable biotherapeutic solutions.
The toxicological study was carried out in compliance with GLP in accordance with the regulations. The animals received three intravenous injections, one week apart, of PolyTope® TATX-03 or a placebo. No mortality was observed and, importantly, no macroscopic or microscopic morphological or histopathological impact was detected on any of the organs and tissues examined, even after an extended observation period, as recommended by the FDA.
In parallel, a comprehensive tissue cross-reactivity (RCT) study was performed according to regulatory guidelines and included colorimetric immunohistochemical analysis of 37 tissues and blood materials from five unrelated human bodies, to cover a wide range of tissues, organs and proteins expressed. These analyzes did not show cross-reactivity of individual TATX-03 antibodies, a result which confirms the specificity of the antibodies to their target and indicates that no unintended binding is expected in humans.
The results of the toxicology study and the TCR study are consistent with the results and conclusions of previous studies live and the dose escalation study, as discussed in the Company’s March 9, 2022 press release. The positive results reported here will be included in regulatory documents for approval of human clinical studies.
“This is another important step for the IPA and a major contribution to efforts to protect against the current and future threat still posed by COVID-19 and its variants. These data confirm the safety of TATX-03, which is in addition to its already demonstrated and, in our opinion, unprecedented resilience, as evidenced by its ability to neutralize all SARS-CoV-2 variants tested so far. said Dr. Ilse Roodink, CSO of IPA. “We are confident about the next steps of the program and are compiling the data to communicate to health authorities for clinical approval,” she continued, “these excellent safety and pharmacokinetic data support our ambition to begin the first human clinical trial which should start later this year”.
ImmunoPrecise Antibodies Ltd.
ImmunoPrecise Antibodies Ltd. is an innovation-driven biotherapeutics company that supports its commercial partners in their quest to discover and develop novel antibodies against a broad range of target classes and diseases. The Company offers a set of services and programs using advanced platforms and technologies intended to optimize the discovery and development of antibodies to fight against rare and/or difficult epitopes. For more information, please visit www.immunoprecise.com.
Forward-looking information
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Forward-looking information involves known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements stated herein to be materially different from any future results, performance or achievements expressed or implied. -understood by 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’s failure to timely submit an application for approval, to develop its PolyTope® TATX-03 by successfully and timely completing clinical trials, or may not receive all regulatory approvals to start and then continue clinical trials of PolyTope® TATX-03, together with the description of the risks disclosed 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, as amended No. 1, dated September 28, 2021 (which may be viewed on the Company’s profile at www.sec.gov). If one or more of these risks or uncertainties materialize, or if the assumptions underlying the forward-looking statements prove incorrect, actual results, performance or achievements may differ materially from those expressed or implied by the forward-looking statements. contained in this press release. Readers are therefore cautioned not to place undue reliance on the forward-looking information contained in this press release.
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SOURCE ImmunoPrecise Antibodies
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