Cyfendus: which tox species, and why?

“All these GLP-compliant toxicology studies were performed in rats.”

“The rat model was chosen for the safety evaluation of AV7909 as it is a widely used species for toxicology studies and rats were shown to respond appropriately to AV7909 and its component, CPG 7909, as confirmed by immunogenicity assessments conducted in each of the studies.”

“Test article-related findings were observed in the adjuvant alone (CPG 7909) group as well as the Anthrax Vaccine Adsorbed (AVA), adjuvanted group with similar frequency and similar severity, which suggests that the findings were mostly induced by the adjuvant.”

“All these GLP-compliant toxicology studies were performed in rats.”

“In a pre- and post-natal developmental study with an embryo-fetal development toxicity phase performed in female rats, a full human dose (0.5 mL) of CYFENDUS was administered by intramuscular injection on three occasions: 14 days prior to start of cohabitation, on the day of cohabitation, and on Gestation Day 7.”

“CYFENDUS has not been evaluated for carcinogenicity, mutagenic potential, or male infertility in animals.”

“The applicant conducted a single-dose acute toxicity study, a repeat-dose safety toxicity study, a pre- and post-natal developmental and reproductive toxicity (DART) study, as well as a juvenile repeat-dose toxicology study. All these GLP-compliant toxicology studies were performed in rats, and animals were dosed with CYFENDUS via IM injection, the intended route for human use.”