IND-Enabling Programs For Adoptive Cell Therapies

Cell therapy is rapidly advancing as a key area in oncology therapeutics, with adoptive cell therapies, particularly CAR-T cells, showing great promise. These therapies involve engineering a patient’s T cells to express chimeric antigen receptors (CARs) that target cancer cells. Preclinical development includes rigorous in vitro and in vivo assessments, such as cytotoxicity evaluations, cytokine profiling, and advanced disease modeling using CDX, PDX, and humanized mouse models.

Safety assessment remains a critical challenge, requiring adaptation of conventional toxicology standards. Emerging modalities, including CAR-NK cells and novel engager therapies, are expanding the field. Regulatory programs such as the FDA’s Fast Track and Breakthrough Therapy designations help expedite the approval of these transformative treatments.