RE:RE:FDA comments on biomarkers as surrogate endpoints for AAMarch 07, 2023 - Tumor infiltrating lymphocytes (TILs), reflect the local tumor microenvironment and may prove to be a superior endpoint in cancer vaccine/oncolytic virus trials.
TILs are lymphocytes that have left the bloodstream, migrated to a tumor, and are at the right time able to recognize and kill cancerous cells . At the site of the tumor, subsets of TILs interact with each other and with other immunologically active cells in complex, symbiotic, and antagonistic ways to form the TME. ONCY's pelareorep is able to increase CelTils scores as outlined in the Aware-1 clinical study, thus remodeling the TME for the sequential addition of immune checkpoint inhibitors (ICIs)
Recent work from the University of Texas Health Science Center has identified the importance of TILs, which is underscored by the developing ability to predict treatment response to ICI therapy (predictive/prognostic biomarkers) based on their density and location, as ONCY has demonstrated. The value of a change in TILs within the TME as a response to cancer immunotherapy has also been demonstrated with immune checkpoint inhibition where an increase in TILs after treatment is prognostic, correlating with an improved survival outcome. ONCY measured the value change of TILs through the use of immunoscores like those used in ONCY's Aware-1 clinical study.