Bioanalytics – Biomolecular
End-to-End Hot Topic
Oncolytic viruses are being explored by many in industry as an effective treatment option for certain cancers with great specificity as a monotherapeutic and in combination with other proven oncology therapeutics. Arming the oncolytic viruses with transgenes can further improve on the potency. However, the development of an armed or unarmed oncolytic virus program comes with a lot of bioanalytical due diligence required in early clinical development to ensure a thorough assessment of risk can be demonstrated. While the platform to measure the circulating and shed virus is typically qPCR, additional assays are needed to monitor the infectivity of the virus in shedding samples. The immunogenicity risk assessment would also need to consider the risk associated with arming the oncolytic viruses with transgenes. An overview of these topics will be presented and case studies presented as available.