$IPA 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
https://www.businesswire.com/news/home/202207...%E2%80%912
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.
July 12, 2022 08:04 AM Eastern Daylight Time
VICTORIA, British Columbia--(BUSINESS WIRE)--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.”
https://www.businesswire.com/news/home/202207...%E2%80%912
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.
July 12, 2022 08:04 AM Eastern Daylight Time
VICTORIA, British Columbia--(BUSINESS WIRE)--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.”
