GlobeNewswire·Jun 1, 2026, 7:30 AM ET

Iovance Biotherapeutics Announces Clearance of Investigational New Drug (IND) Application for IL-12 Tethered TIL Therapy IOV-5001

Iovance Biotherapeutics received FDA allowance to proceed with an investigational new drug application for IOV-5001, a next-generation IL-12 tethered TIL therapy.
A Phase 1/2 basket trial for IOV-5001 is scheduled to begin patient enrollment in the second half of 2026.
The trial will evaluate a one-time treatment regimen that does not utilize IL-2.
Trial cohorts include advanced colorectal, triple-negative, & estrogen receptor-low breast cancers, plus other solid tumors representing over 100,000 U.S. deaths annually.
IOV-5001 is engineered to express IL-12 only within the tumor & tether it to the cell surface to prevent bloodstream release & optimize safety.
The therapy is designed to deliver higher cell doses & activate immunologically cold tumors, building on prior secreted IL-12 TIL therapies that achieved a 63% confirmed objective response rate.
Preclinical studies indicate IOV-5001 demonstrates stronger antitumor activity & a healthier T cell profile compared to unmodified TIL therapies.