Iovance gets FDA nod for IOV-5001 Phase 1/2 trial in solid tumors

Iovance Biotherapeutics received U.S. FDA allowance for its Investigational New Drug (IND) application for IOV-5001, a next-generation interleukin-12 (IL-12) tethered TIL therapy. The company plans to initiate a Phase 1/2 basket trial in the second half of 2026, targeting advanced colorectal, triple-negative, and estrogen receptor-low breast cancers, as well as other highly prevalent solid tumors responsible for over 100,000 U.S. deaths annually. IOV-5001 is engineered to enhance efficacy in immunologically 'cold' tumors and improve safety by localizing IL-12 activity within the tumor, building on prior therapy that showed a 63% objective response rate.