NEW YORK – Iovance Biotherapeutics on Tuesday said it has gotten permission from the US Food and Drug Administration to begin clinical trials of its gene-edited, autologous tumor-infiltrating lymphocyte (TIL) treatment in advanced melanoma and non-small cell lung cancer patients.
The FDA cleared Iovance's investigational new drug application for IOV-4001, which the company will now study in patients with unresectable or metastatic melanoma and stage III or IV NSCLC. The therapy involves harvesting patients' TILs and using a gene-editing technology, dubbed TALEN, to modify the TILs such that the gene coding for the PD-1 protein becomes inactivated. This allows T cells to recognize and attack cancer cells.
Iovance licensed the TALEN technology from Cellectis in January 2020. Under the terms of that agreement, Iovance can use TALEN to modify TILs for multiple cancer indications and address various gene targets.
In preclinical mouse models, the edited approach to autologous TIL therapy was superior to non-edited TIL therapy, according to Iovance. The firm is also developing an unselected, non-edited autologous TIL product, lifileucel, for metastatic melanoma patients, but has run into regulatory difficulties, particularly with the potency assay needed to define lifileucel's activity.
"IND allowance for IOV-4001 in two advanced cancers is an exciting milestone in the evolution of our TIL platform as we incorporate the gene editing TALEN technology to develop next-generation TIL therapies," Iovance Interim President and CEO Frederick Vogt said in a statement. "IOV-4001 provides a significant opportunity to deliver the combination of TIL and immune checkpoint inhibition within a single genome-edited TIL therapy in multiple solid tumor types."
The San Carlos, California-based company will begin trials of IOV-4001 this year.