Immunoprecise's COVID-19 Antibody Cocktail Shows Favorable Safety, Toxicity Profile

Immunoprecise Antibodies Ltd IPA has reported preclinical data of PolyTope TATX-03 antibody cocktail therapy against COVID-19.
The IND-enabling animal studies did not show any observable acute adverse events and supported a favorable safety profile.
As a prelude to a formal toxicology study, a maximum tolerated dose and a pharmacokinetic study was completed using injections of up to 12.5 times the anticipated highest dose proposed for the phase 1 trial.
The results did not demonstrate any adverse clinical signs or any observable effect in behavior, appetite change, or weight change in any animals.
Related: ImmunoPrecise's COVID-19 Antibody Cocktail Shows Neutralization Activity Against Omicron.
The FDA has advised examining the build-up of antibody serum concentrations in the laboratory animal model versus humans, recommending a study design adaptation to increase the number of injections and monitor the elimination of antibodies from the animals.
Therefore, the ongoing final GLP toxicology study is extended by eight weeks, with the final data being available in mid-June 2022.
The Company expects Investigational New Drug (IND) filing to the FDA in early Q3.
Price Action: IPA shares are down 5.77% at $3.92 during the market session on the last check Wednesday.