KSQ doses first solid tumor patient with gene-edited TIL therapy

KSQ Therapeutics announced the first patient dosed in a phase 1/2 clinical study of KSQ-004EX, a novel CRISPR-engineered tumor infiltrating lymphocyte (eTIL) therapy, in advanced solid tumors.

The phase 1/2 trial is an open-label, dose escalation study for patients with advanced solid tumors (including melanoma, non-small cell lung cancer), head and neck squamous cell carcinoma, colorectal cancer, pancreatic cancer, and cervical cancer. The primary objective of the phase 1 portion of the trial is to evaluate the safety and tolerability of KSQ-004EX; the phase 2 portion will evaluate antitumor activity in indication-specific cohorts.

KSQ-004EX is an autologous cell therapy generated from TIL engineered with CRISPR/Cas9 to inactivate SOCS1 and Regnase-1 to maximize anti-tumor activity. KSQ used its proprietary CRISPRomics platform to identify SOCS1 and Regnase-1 as key genes inhibiting the ability of TIL to eradicate solid tumors in preclinical models.

The first patient was treated at the University of Texas MD Anderson Cancer Center.