The CRIPSR-edited neoantigen-specific T cell therapy demonstrated safety and feasibility in the first-in-human PACT-0101 study presented at SITC 2022.
“We are working on developing a personalized adoptive cell therapy for patients. A lot of therapies right now that are using cell therapy do start and end with the patient's own cells. But where our approach differs is that we actually screen the patient's own cells for their cure. So, in theory, any patient has immune cells that can recognize their own tumor. What we wanted to do is find those cells and create a therapy using those cells.”
The personalized, autologous T cell therapy NeoTCR-P1 (Pact Pharma) has demonstrated safety and feasibility in the phase 1 first-in-human PACT-0101 study (NCT03970382). Data from the study were presented by Susan Foy, PhD, director, clinical immunology, Pact Pharma, at the Society for Immunotherapy of Cancer’s (SITC) 37th Annual Meeting, November 8-12, 2022, in Boston, Massachusetts.
NeoTCR-P1, which stands for neoantigen-specific T cell receptor, is created from cells isolated from the patients’ circulating CD8 T cells using the imPACT Isolation Technology®. Cells are then edited using CRISPR into an autologous apheresis product for reinfusion after conditioning chemotherapy. The therapy consists of up to 3 distinct neoTCR T cell products for each patient to be infused. PACT-0101 is evaluating NeoTCR-P1 alone or in combination with IL-2 and has dosed 16 participants with solid tumors at dose levels of 400×106, 1.3×109, and 4×109 total neoTCR+ cells.
CGTLive spoke with Foy about the results of the phase 1 portion of the study, which demonstrated that the therapy was feasible to manufacture, was well-tolerated, and that the transgenic cells persisted and trafficked to patients’ tumors. She also detailed the 3 technologies used to produce the 3 neoTCR T cell products that make up the therapy.