NEW YORK – Iovance Biotherapeutics said on Monday that it has dosed the first patient in a Phase I/II trial of IOV-4001, a genetically modified tumor-infiltrating lymphocyte therapy.
The trial, dubbed IOV-GM1-201, is enrolling 53 patients with previously treated, unresectable or metastatic melanoma or stage III or IV non-small cell lung cancer. The therapy involves harvesting TILs from patients' tumors, modifying them, and using a gene editing technology called TALEN to inactivate the gene encoding PD-1. San Carlos, California-based Iovance believes that inactivating PD-1 could enhance the TIL therapy's antitumor activity, allowing patients' immune cells to better recognize and attack tumor cells.
According to Iovance, the first patient dosed has also completed the safety observation period.
"Dosing the first patient with IOV-4001 is an important first step in providing proof of concept for delivering genetically modified TIL therapy to solid tumor patients with significant unmet needs and few treatment options," Iovance Chief Medical Officer Friedrich Graf Finckenstein said in a statement. "This trial may also support our broader platform of genetically modified Iovance TIL therapies to potentially address difficult-to-treat solid tumor cancers."
The IOV-4001 trial comes while the firm is still working on garnering approval for its unselected, non-modified autologous TIL therapy, lifileucel, as a treatment for advanced melanoma patients. In August, the firm began filing rolling regulatory submissions with the US Food and Drug Administration to expedite evaluation and market authorization for lifileucel. Iovance has had to delay its regulatory timeline for lifileucel several times in recent years.