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KSQ Therapeutics Treats First Patient in Phase I/II Trial of Engineered TIL Therapy

NEW YORK – KSQ Therapeutics on Wednesday said the first patient has received its gene-edited tumor-infiltrating lymphocyte (TIL) therapy, KSQ-001EX, within a Phase I/II clinical trial.

The Lexington, Massachusetts-based firm is studying KSQ-001EX, which it describes as an engineered TIL, or eTIL, in patients with melanoma, head and neck squamous cell carcinoma, and non-small cell lung cancer. In the Phase I portion of the trial, KSQ is determining the safety and tolerability of KSQ-001EX.

The treatment involves harvesting patients' TILs, engineering them using CRISPR-Cas9 to knock out the SOCS1 gene, then reinfusing the cell therapy to target patients' solid tumors. The firm identified SOCS1 using its CRISPRomics platform as a key regulator of the anti-tumor potency and persistence of TILs. In the Phase I portion of the trial, patients will not receive conditioning therapy with interleukin-2, but will receive lymphodepleting chemotherapy prior to their TIL infusion.

In the Phase II portion of the trial, KSQ plans to study the TIL therapy's anti-tumor activity in specific patient cohorts.

The firm is betting that its engineered TIL therapy can enhance the anti-tumor activity, polyclonality, persistence, and memory formation of the TILs versus unmodified TIL therapy.