Definition

A preparation of autologous tumor infiltrating lymphocytes (TILs) gene-edited with the clustered regularly interspaced short palindromic repeats (CRISPR)-Cas9 nuclease complex to inactivate the endogenous gene suppressor of cytokine signaling 1 (SOCS1), with potential immunomodulating and antineoplastic activities. Upon infusion of the autologous CRISPR-Cas9 engineered TILs KSQ-001EX back into the patient, the cells specifically recognize, target and kill the patient’s tumor cells. SOCS1 serves as a negative regulator of cytokine signaling in T cells and negatively influences the survival, differentiation, and function of T cells. Inactivation of endogenous SOCS1 in TILs increases responsiveness to cytokine signals, and enhances anti-tumor potency, persistence and memory formation of TILs.