News Link: https://www.businesswire.com/news/home/20220309005568/en/
In vivo, IND enabling evaluations of PolyTope® TATX-03 in animal model show:
- There were no pharmacokinetic aberrations
- Injection with TATX-03 is well tolerated – with a significant safety margin and no clinical signs of toxicity
- Maximum tolerated dose study evaluating up to a 12.5-fold higher amount than the highest dose anticipated for use in humans did not uncover any observable clinical signs of toxicity
March 09, 2022 08:01 AM Eastern Standard Time
VICTORIA, British Columbia–(BUSINESS WIRE)–IPA (IMMUNOPRECISE ANTIBODIES LTD.) (the “Company”) (NASDAQ: IPA) (TSXV: IPA) is pleased to report on the latest progress in the development of their PolyTope® TATX-03 antibody cocktail therapy with a proven strong efficacy against all tested SARS-CoV-2 variants-of-concern. The Company reports positive data indicating their recent IND-enabling animal studies do not show any observable acute adverse events, data which supports a highly positive safety profile for TATX-03 as a clinical product. In addition, results from the FDA reviewed and recommended animal study protocols demonstrate that the in vivo pharmacokinetic profiles of the individual antibodies show no aberrations, and each antibody demonstrates a characteristic human IgG1 pharmacokinetic profile.
As a prelude to a formal toxicology study, a maximum tolerated dose and a pharmacokinetic study were completed using injections of up to 12.5 times the anticipated highest dose proposed for the phase 1 clinical trial. The results did not demonstrate any adverse clinical signs, nor any observable effect in behavior, change in appetite, or change in weight, in any of the animals. In addition, monitored vitality indicators, such as body temperature, stayed within their respective physiological ranges, and no post-mortem macroscopic tissue anomalies were observed. In vivo animal serum profiles of each antibody were in full accordance with those expected for human immunoglobulins.
To promote IND approval and a seamless transition to the clinic, the company engages in on-going communications with the FDA regarding the TATX-03 data package. The FDA has advised to enhance the preclinical safety evaluation by 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 to monitor the elimination of antibodies from the animals. The ongoing final GLP toxicology study is therefore extended by eight weeks with the final data being available mid-June, 2022. These current advancements allow scheduling of Investigational New Drug (IND) filing to the FDA early Q3. Importantly, the timelines for completion of clinical batch production nor the launch of the intended phase 1 clinical trial are not impacted and on schedule as planned.
“The lack of any adverse event, of morbidity, of mortality, of any observable effect in any of the rodents injected with an order more of the highest intended clinical dose of TATX-03, is very encouraging and supports that we have developed a very efficacious and resilient SARS-CoV-2 therapy with an expectedly high safety profile,” stated Dr. Ilse Roodink, CSO of IPA.
“Although we are awaiting the outcome of the final GLP toxicology study, all signs indicate that we have designed a safe and effective pharmaceutical,” added Dr. Roodink. “We are eager to proceed quickly but carefully to the first clinical trial phase as soon as the TATX-03 drug product is ready for distribution.”
Leave a Reply