FDA Clears Iovance's IOV-5001 IND; Phase 1/2 Solid Tumor Trial Enrollment Planned for H2 2026 (IOVA)

Iovance Biotherapeutics (IOVA) said the U.S. Food and Drug Administration cleared its investigational new drug application for IOV-5001, an engineered interleukin-2 analog, for the treatment of solid tumors. The company announced the regulatory milestone on June 2, 2026. Patient enrollment in a Phase 1/2 clinical trial is expected to begin in the second half of 2026. IOV-5001 is designed to selectively stimulate cancer-fighting T cells while minimizing the severe side effects linked to traditional high-dose IL-2 therapy. The clearance expands Iovance's pipeline beyond its approved tumor-infiltrating lymphocyte therapies into next-generation cytokine treatments. No financial terms or specific tumor types for the initial trial were disclosed.