Q&A: Building new models for preclinical in vivo immuno-oncology efficacy studies

The research and development of new drugs must complete a triathlon of drug discovery, preclinical research and clinical trials before benefiting the patients. It is a long and arduous research process. 

Where preclinical research begins, there are four main systematic studies on involved：

Pharmaceutical research of APIs and formulation

Pharmacological efficacy

DMPK

Safety assessment

The latter three studies mentioned require in vivo testing. 

Pharmacodynamics research is to answer the mechanism of drug action to determine the dosage and frequency of drug administration. Finding suitable molecules and cells for in vitro efficacy evaluation while building a symptomatic animal model for in vivo efficacy evaluation is the key in this research phase. 

DMPK research studies the absorption, distribution, metabolism, and excretion properties (ADME) of drugs in animals to guide the form of drug administration in clinical research. Additionally, DMPK helps to determine the frequency and dosage of new drug. 

Safety assessment needs to be evaluated in at least two animal species. The key results of toxic target organ, maximum tolerated dosage and no obvious toxic reaction dosage can provide a basis to determine the starting dosage for the first human trial and to formulate risk prevention and control measures in human clinical trials. For new drugs that require long-term use to treat chronic diseases, it is necessary to conduct toxicological experiments for a longer period of time. These demonstrate that animal models are an indispensable part of preclinical drug development.

The establishment and selection of appropriate animal models fully comprehend each aspect of pharmacological efficacy, DMPK and safety assessment. 

Difficulties arise when trying to establish the model, or when trying to select a model after establishment. Such challenges cause misleading or ineffective clinical results from animal model testing. That is, the clinical transformation falls short.

BioDuro-Sundia animal models for oncology immunotherapy continue to expand; both increasing the number of models and expanding into new types of models. BioDuro-Sundia capabilities in this area of preclinical research is exceptionally systematic and comprehensive. We’ve accumulated vast historical data and indispensable first-hand experiences in pharmacology efficacy. As market demand for pharmacology efficacy grows, so too does BioDuro-Sundia’s strategic investment and efforts to advance the area.