FDA OKs Trial of TIL Therapy in Skin, Head and Neck and Lung Cancers

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The Food and Drug Administration gave the green light to a phase 1/2 trial of KSQ-001EX for patients with melanoma, head and neck squamous cell carcinoma and non-small cell lung cancer.

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The Food and Drug Administration (FDA) OKs a phase 1/2 clinical trial of KSQ-001EX for the treatment of patients with melanoma, head and neck squamous cell carcinoma and non-small cell lung cancer, according to a press release from KSQ Therapeutics, the manufacturer of the novel drug.

KSQ-001EX is made of tumor-infiltrating lymphocytes (TILs), which are immune cells that recognize and attack cancer. The drug blocks the SOCS1 gene by using KSQ’s CRISPRomics platform to edit the CRISPR/Cas9 gene.

"Our team has made great progress advancing our KSQ-001EX and KSQ-004EX eTIL® programs. Through our platform insights, we've identified how to enhance the effectiveness of T cells in the treatment of solid tumors. We believe our eTIL® cell therapies have tremendous potential to benefit patients with cancer who have limited treatment options. We look forward to working closely with the clinical experts at MD Anderson, where the study will be initiated,” said Qasim Rizvi, chief executive officer of KSQ, in the press release.

READ MORE:TIL Therapy Is One of Many ‘Phenomenal Discoveries’ in Melanoma Treatment

The FDA granted an Investigational New Drug application for the trial, which, according to the agency’s website, allows for the study of a new, unapproved drug, or for the study of a drug in a population for which the therapy is not yet approved.

The trial will be conducted at The University of Texas MD Anderson Cancer Center and the Cell Manufacturing Center (CMTC). The main goal of the first phase of the trial is to evaluate the safety and tolerability of KSQ-001EX, including a cohort of patients who will be initially dosed with IL-2. Then, the phase 2 portion of the trial will evaluate the antitumor (cancer-killing) capabilities of the drug in specific groups of patients.

“Our partnership with CTMC has yielded a robust manufacturing process for our eTIL® cell therapy that is derived from patient tumor samples, including core biopsies. The collaborative effort allowed the IND to be submitted in an accelerated timeframe,” Rizvi said.

Preclinical trials — meaning research that has not been conducted in humans — showed that KSQ-001EX is functional and has anti-tumor capabilities.

“New treatment options are urgently needed in melanoma and other solid tumors, and the potential to improve outcomes and patient experience is very exciting. KSQ-001EX exhibited considerable efficacy in preclinical studies,” said Dr. Rodabe Amaria,, professor of Melanoma Medical Oncology at The University of Texas MD Anderson and principal investigator of the KSQ-001EX study. “We look forward to working closely with KSQ as we advance this program.”

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