Proven Intelligence Accelerating Next-Generation Therapies.

Executive Summary

Traditional pharmacodynamic (PD) assessments that rely on terminal endpoints are insufficient for characterizing the complex, dynamic behavior of cell-based therapeutics like CAR-T, CAR-NK, or iPSC-derived candidates. This page details a multi-modal in vivo imaging strategy that combines Magnetic Resonance Imaging (MRI), Positron Emission Tomography (PET), and Bioluminescence Imaging (BLI) to generate a longitudinal, quantitative data package. This approach provides a comprehensive understanding of cell trafficking, persistence, and functional activity, minimizing clinical risk and supporting a robust IND submission within an 18-24 month timeline.

The Limitations of Terminal Endpoints

Assessing the in vivo activity of somatic cell therapies presents a distinct set of challenges. Unlike static biologics, the biodistribution and functional persistence of CAR-T, TCR-T, or stem cell therapeutics are dynamic processes. Relying solely on terminal histology and tissue analysis provides only a single snapshot in time, failing to capture the kinetics of cell trafficking, expansion, and clearance.

A tailored preclinical strategy is required to build a complete narrative of the therapeutic’s mechanism of action. This involves generating longitudinal data that visualizes and quantifies the asset’s behavior over the full course of a response.

A Multi-Modal Imaging Strategy

A more robust approach integrates several non-invasive imaging modalities to build a complete pharmacodynamic profile. Each technique provides a unique layer of information, creating a comprehensive dataset.

• Bioluminescence Imaging (BLI): Ideal for high-throughput, sensitive tracking of luciferase-expressing cells. BLI provides a clear signal for cell localization and viability over time.

• Positron Emission Tomography (PET): Offers quantitative data on metabolic activity or receptor occupancy. Using specific radiotracers, PET can confirm not just where the cells are, but if they are functionally active.

• Magnetic Resonance Imaging (MRI): Delivers high-resolution anatomical detail. MRI is used to co-register functional data from BLI or PET, providing precise anatomical context for cell localization and assessment of downstream physiological effects, such as changes in tumor volume.

This combination of techniques generates High-Fidelity In Vivo Intelligence for Complex Modalities.

Precision Delivery and Quantitative Monitoring

The quality of a pharmacodynamic assessment begins with reproducible administration. As demonstrated in advanced vector applications, MRI-guided frameless stereotactic systems enable highly accurate, real-time visualization of therapeutic delivery to specific anatomical locations (PMID: 38310346). This technical precision minimizes variability between subjects and ensures that observed effects are a direct result of the therapeutic’s action at the intended site.

Following administration, quantitative monitoring of the therapeutic is a requirement for a robust data package. The principles established for non-invasive imaging of gene transfer, using reporter systems to track payload expression via imaging like SPECT, can be extrapolated to cell therapies (PMID: 12639305). This allows for longitudinal quantification of cell persistence and activity, providing a powerful dataset for modeling human dose-response relationships.

Animal Welfare and Enhanced Data Collection

Implementing a longitudinal, non-invasive imaging strategy directly aligns with our commitment to the 3Rs principle (Replacement, Reduction, and Refinement) of animal welfare. By collecting multiple data points from the same animal over time, this approach significantly reduces the total number of animals required for a study compared to designs that depend on separate cohorts for each terminal timepoint.

Our programs are AAALAC accredited and USDA compliant, with a focus on enhanced housing and social enrichment.