KSQ Therapeutics Launches Phase 1/2 Trial of a Pioneering CRISPR-Engineered TIL Therapy for Solid Tumors
LEXINGTON, Mass., April 9, 2025 – KSQ Therapeutics, Inc. (KSQ) today announced the initiation of its Phase 1/2 clinical trial with the first patient dosed in the study of KSQ-004EX, a novel CRISPR-engineered Tumor Infiltrating Lymphocyte (eTIL®) therapy targeting advanced solid tumors.
KSQ-004EX utilizes CRISPR/Cas9 gene editing to inactivate the SOCS1 and Regnase-1 genes within TILs, a modification identified through KSQ’s CRISPRomics® platform to enhance anti-tumor activity.”KSQ-004EX aims to significantly improve TIL therapy outcomes by overcoming current limitations,” said Qasim Rizvi, CEO of KSQ.
The open-label, dose-escalation trial will evaluate safety, tolerability, and anti-tumor activity in patients with melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), colorectal cancer (CRC), pancreatic cancer, and cervical cancer. KSQ-004EX is an autologous cell therapy where a patient’s own TILs are engineered to improve tumor infiltration and killing. Preclinical data supports its potential to enhance TIL efficacy. KSQ Therapeutics focuses on developing innovative cell therapies for solid tumors.
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