The recent advances in cancer immuno-oncology research have changed the cancer drug development standard of care from traditional chemotherapeutics to immunotherapies. New therapeutic classes are emerging, with the focus on checkpoint inhibitors, cancer vaccines, oncolytic viral vectors, and adoptive T-cell immunotherapies to modulate tumor immune responses and build on the successes of these strategies. Advancing new drug candidates through preclinical studies into clinical trials has created a need for specialized immuno-oncology preclinical approaches.
At IITRI, the cornerstone of our immuno-oncology therapeutic development services is a strong scientific foundation in immunology and cancer biology. We offer preclinical services from translational models and full characterization of immune responses to IND-enabling GLP toxicology and safety studies.
Screening new therapies and using translational animal models is an essential component of a development program for new cancer immunotherapies. IITRI now offers immunoprofiling services to support efficacy proof of concept studies in xenograft and syngenic mouse tumor models.
- Immunophenotyping with multi-color FACS
- Cytokine panels
- ELISpot assays
- Cytokine panels
- In vitro and in vivo T cell exhaustion models
Biodistribution of viral or nucleic acid-based vectors following dosing is recommended by the FDA for assessment of the vector presence, persistence, and clearance profile of the vector. IITRI is well equipped to perform qualified or GLP-compliant biodistribution analyses in tissues and fluids for vector or transgene quantitation in tissue or fluids.
- qPCR, RT-qPCR
Cancer Immunotherapy Toxicology Studies
IITRI offers the unique combination of expert toxicology along with molecular biology and virology capabilities for conducting GLP toxicology studies in mouse tumor models, rodents, nonrodents, or NHPs. We can accommodate gene therapy viral vectors and oncolytic viral vectors requiring BSL-2 for efficacy through toxicology studies, and offer a full suite of bioanalytical assays. Our experience also includes conducting preclinical toxicology studies for cancer therapetuics supporting the successful filing of over 20 INDs for the National Cancer Institute (NCI). Our PhD, DABT study directors are available for consultation for study design and execution tailored to your requirements.
- GLP toxicology and safety studies
- BSL-2 facilities for toxicology studies
- Histopathology services
- Small molecule and biologic bioanalytical
- Molecular biology and immunology laboratory support
- Rodent, non-rodent and NHP studies
- Anti-drug antibody (ADA) ELISAs
- Neutralizing antibody (NAb) assays