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KSQ Therapeutics Receives FDA Clearance for IND Application of KSQ-001EX, a CRISPR/Cas9 Engineered Tumor Infiltrating Lymphocyte (eTIL®) Therapy

Thursday, November 30, 2023

KSQ Therapeutics, Inc. (KSQ) recently obtained FDA clearance for an Investigational New Drug (IND) application for its Phase 1/2 clinical study of KSQ-001EX, an engineered tumor-infiltrating lymphocyte (eTIL®) program. This collaboration involves The University of Texas MD Anderson Cancer Center and the Cell Therapy Manufacturing Center (CTMC).

KSQ-001EX involves TILs with the deactivated SOCS1 gene through CRISPR/Cas9 gene editing. This editing was identified through KSQ's CRISPRomics® platform as pivotal in enhancing TIL's anti-tumor effectiveness and longevity in treating solid tumors.

Qasim Rizvi, CEO of KSQ, expressed excitement for their advancements, highlighting potential benefits for patients with limited cancer treatment options. Collaboration with MD Anderson for the study signifies a significant step forward. Dr. Rodabe Amaria from MD Anderson expressed enthusiasm for KSQ-001EX's efficacy in preclinical studies and anticipates working closely with KSQ to advance the program.

The Phase 1/2 trial will focus on melanoma, head and neck squamous cell carcinoma (HNSCC), and non-small cell lung cancer (NSCLC) patients. Phase 1 will assess safety and tolerability, initially dosing a patient cohort without IL-2. Phase 2 will concentrate on evaluating antitumor activity within specific cohorts.

KSQ-001EX, KSQ's flagship eTIL® cell therapy, holds promise in revolutionizing solid tumor treatments. Preclinical studies showed its superior anti-tumor abilities in models resistant to PD-1 inhibition, alongside improved persistence and memory formation.

This milestone represents a significant leap forward in developing enhanced treatments for solid tumors, showcasing the potential of engineered TILs in reshaping cancer therapy.



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