Principal Scientist, Group Leader Merck & Co., Inc.
Oncolytic virus is a new modality to preferentially infect and kill cancer cells. When combined with immune checkpoint inhibitor such as Keytruda, the tumor antigen released by oncolytic virus killing will facilitate immune response against tumor. So despite in the format of a virus, oncolytic virus functions more like a typical biologics. Due to high immunogenicity of most of the virus and repeated dosing in clinical trials, it is expected that high titer of anti-virus Ab will be induced. Comparing to a typical biologics such as mAb drug, what’s the best strategy for Nab testing for oncolytic virus? Should we still test total anti-virus Abs? Should titer be tested in addition to positivity? Should cut point or Neutralization Titer 50 (NT50), which is widely used in the filed of vaccine, be used for titer calculation? How to report oncolytic virus Nab data? These are the gaps and questions we will try to address in this case study report.
• Develop a strategy for assays needed for virus-based therapies, esp, Nab assays;
• Learn novel Nab assay platform/technology;
• Inform audience of leveraging vaccine-based assays for biologics.