Iovance receives FDA clearance for IL-12 tethered TIL therapy trial

Iovance Biotherapeutics Inc. (NASDAQ: IOVA) received clearance from the U.S. Food and Drug Administration to proceed with an investigational new drug application for IOV-5001, an interleukin-12 tethered tumor infiltrating lymphocyte therapy.

The company plans to begin enrolling patients in a Phase 1/2 basket trial during the second half of 2026. The trial will investigate the safety and efficacy of a one-time IOV-5001 treatment regimen without the use of IL-2. Patient cohorts will include advanced colorectal cancer, triple-negative breast cancer, estrogen receptor-low breast cancer, and other solid tumors.

IOV-5001 is engineered to express IL-12 only within tumors and tethers IL-12 to the cell surface to prevent release into the bloodstream. The therapy targets immunologically cold tumors and is designed to deliver higher cell doses compared to earlier treatments.

"Proceeding into the clinical trial of IOV-5001 is a defining moment as we extend our TIL platform across additional prevalent solid tumors," said Frederick Vogt, Interim Chief Executive Officer and President of Iovance.

The targeted solid tumors represent more than 100,000 U.S. deaths annually, according to data from the Surveillance, Epidemiology, and End Results Program Cancer Stat Facts accessed in May 2026.

Preclinical studies showed IOV-5001 demonstrated stronger antitumor activity and a more durable T cell profile compared to unmodified TIL therapies. An earlier secreted IL-12 TIL therapy showed a 63% confirmed objective response rate in previous research.

Iovance's Amtagvi is the first FDA-approved T cell therapy for a solid tumor indication. The San Carlos, California-based company focuses on developing polyclonal tumor infiltrating lymphocyte therapies for cancer patients.

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