Abstract

Immuno-Oncology Trial Monitoring Directly From Whole Blood or Tissue with qPCR-Assisted Cell Counting (qPACC)

Thomas-Oliver Kleen, Executive VP, Epiontis GmbH

Novel immunotherapy agents like anti-CTLA-4 and anti-PD1/PD-L1 have made immune monitoring in clinical trials a vital part based on the mechanism of action of these drugs.  Monitoring both systemic changes in the blood and intra-tumoral changes of relevant leukocyte sub-populations aids the development of early surrogate markers of therapy success or warning signs of increased inflammatory processes or autoimmunity. Epigenetic based, quantitative real-time PCR assisted cell counting (qPACC) performed under ISO 17025 allows precise and robust quantification of immune cells in all human samples from only small amounts of blood or tissue. Samples can be simply frozen and easily shipped, leading to less costly logistics, far less sample requirements, and no need for viability and/or stability of cells as required for Flow cytometry and ELISPOT. This allows the unprecedented capability to monitor patients Immuno-oncology trials with regulatory T cells (Tregs), Th17 cells, Tfh cells, CD4+ and CD8+ cells, overall T cells (CD3+), B cells, NK cells (CD56 dim), neutrophil granulocytes and monocytes are the first examples of a next generation of Immuno-oncology biomarker tools that can be used in these settings.