Challenges Associated with Identifying Preclinical Animal Models for the Development of Immune-based Therapies

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Background

There hasn’t been a better time to be a drug developer for immune-based therapies than the past couple of decades. We have seen an explosion in immune-based therapies for cancer, autoimmune and infectious diseases, metabolic diseases and diseases and disorders of the nervous system. The modalities of these immune-based therapies span small molecules, biologics, and gene and cell therapeutic approaches. Significant advances have been made in optimizing drug design for its specificity for the target, characterizing the mode of action in in vitro assays, and ensuring safety and manufacturability. However, an area of challenge that remains is identifying animal models for evaluating efficacy and pharmacokinetics/pharmacodynamics relationship that are predictive of drug effects in humans. Discussion on this topic is warranted as examples of failures of translation from animal models to humans provide us an opportunity to learn more about human biology.

Preclinical animal models used in developing immune-based therapies include syngeneic mouse models, humanized mouse models, and non-human primates. The ultimate goal of experiments performed in preclinical animal models is to gain an insight into the drug’s therapeutic window: a dose range below the maximum tolerated dose in which a therapeutic effect is observed. Information on the rationale behind the choice of preclinical models is fragmented and is often focused on safety evaluation. In this research topic, we aim to generate a collection of articles that discuss the scientific rationale behind the choice of preclinical animal models across different drug modalities and diverse therapeutic areas. These articles can also focus on examples of the failure of translation to human biology and progress in the development of animal models of disease such as humanized mouse models and studies in non-human primates.

In this Immunology research topic, we would like to cover a wide range of topics including reviews, research articles, animal model development, and short reports in the areas of vaccines, small and large molecule immune-based therapies for cancer and autoimmune diseases.

The followings are the sub-topics:

1. Challenges in choosing preclinical animal models that predict outcomes in human trials. The Analysis of the efficacy, safety and therapeutic index.
2. Development of humanized mouse models for cancer, inflammation, and vaccine development.
3. The power and limitations of non-human primates as translational models for vaccines, immuno-oncology, and autoimmune diseases.
4. Genetically engineered models.
5. Preclinical models based on therapeutic modality; small molecules, biologics, cell, and gene therapy.
6. FDA/EMA compliance and regulatory considerations.

Dr. Rajat Varma works at AztraZenica and is the Director of Oncology Research (Nextgen IO).
Dr. Rajan Adhikari works at BioTherapeutics Inc. and is the Associate Director of Bacterial Therapeutics.

PLEASE NOTE: Manuscripts consisting solely of bioinformatics or computational analysis of public genomic or transcriptomic databases which are not accompanied by robust and relevant validation are considered out of scope of this section.

Keywords: animal models, cancer, Immune based therapies

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