Histopathology Data of Preclinical Repeated Dose Toxicity 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.
https://www.businesswire.com/news/home/20220712005717/en/Histopathology-Data-of-Preclinical-Repeated-Dose-Toxicity-Study-and-ex-vivo-Human-Tissue-Cross-Reactivity-TCR-Analysis-Support-Safety-of-IPA%E2%80%99s-PolyTope%C2%AE-TATX-03-a-Synergistic-Antibody-Cocktail-against-SARS%E2%80%91CoV%E2%80%912