Cancer Vaccines: BIO Comments to FDA on Clinical Considerations for Therapeutic Cancer Vaccines

Comments asking for clarification on the method used to calculate a preclinical dose which exceeds the clinical dose, and recommends methods currently in practice for other non-oncology vaccines. We also propose incorporating a dosing schedule based on the immune response expected in the early phase clinical trial, rather than one that mimics the intended schedule for the early phase clinical trial as closely as possible.

BIO comments to the FDA