What goes in the regulatory clinical pharmacology package for an oncolytic virus?

Abstract

OVs are natural or genetically modified viruses designed to selectively replicate in tumor cells, resulting in tumor cell lysis, that is, a direct oncolytic effect. The destruction of tumor cells leads to the release of viral particles (VPs) that infect surrounding tumor cells and release tumor-derived antigens, which are presented to T-cells. This process results in a cascade of adaptive immune responses (e.g., T-cell activation, memory, migration, infiltration, and T-cell mediated tumor death) leading to a systemic antitumor immune response. OV replication and amplification after administration into the tumor cells are major determinants of tumor eradication [1,2]. The paper aims to guide the readers through the conceptual framework of OV drug development in the current regulatory environment.