.png)
The Goal
A clinical-stage cell and gene therapy company ($200M+ raised), needed to rigorously monitor pharmacodynamics and immune correlates of response in a complex clinical trial. The developer required multiparameter longitudinal cytometry analysis to quantify immune cell phenotypes and states (e.g., CD4+ T Central Memory Cells, PD-1+ expression) across multiple dose escalation cohorts. They sought to distinguish immune signatures between dosage levels as the trial progressed toward Phase 2.
The Solution
The client selected Teiko’s Standard 25-marker Human PBMC Pan-Immune Profiling Spectral Flow panel to process and profile peripheral blood mononuclear cells (PBMCs) collected from cancer patients enrolled in their Phase I/II trial.
- Scope: The project began with an initial cohort of 112 samples and, following successful execution, expanded to a second statement of work for an additional 170 samples.
- Rigorous QC: Teiko implemented a multi-step quality control process, including cell count and viability checks (>2.0M live cells required) and client-approved gating schemes to ensure data transparency before analysis.
- Core Analytics: Interactive charts to profile immune composition, PCA to assess group-level variation, boxplots and volcano plots to quantify changes in immune populations across study endpoints, and automatic statistical testing to provide p-values for all comparisons.
- AI Analytics: Ranked statistics to identify the most meaningful shifts from baseline across cell populations, functional markers, and expression levels, along with AI-driven interpretation that connects significant findings to potential mechanisms and outcomes.
The Results
Teiko delivered gated data, statistical tables, and secure access to the TokuProfile Dashboard for visualization and interpretation.
- Speed: Analysis and deliverables were provided within weeks for each cohort.
- Depth: The panel allowed the client to quantify specific cell marker-positive subsets as a percentage of parent populations and analyze Median Fluorescence Intensity (MFI) for key markers like PD-1 and HLA-DR.
- Scalability: The successful delivery of the initial 112-sample project led to an immediate expansion to process 170 additional samples across 7 batches. To ensure data integrity across these longitudinal timepoints, Teiko implemented batch control techniques to significantly reduce run-to-run variation.
- Planned Analysis: As clinical outcomes mature, the developer plans to use the generated high-fidelity immune data to stratify Complete Responders, Partial Responders, and Non-Responders.
