Next-Generation Platform Expands into Solid Tumors
Representing 100,000+ U.S. Deaths Annually
SAN CARLOS, Calif., June 01, 2026 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced allowance to proceed from the U.S. Food and Drug Administration (FDA) for the investigational new drug (IND) application for a Phase 1/2 basket trial of IOV-5001, a next-generation interleukin-12 (IL-12) tethered TIL therapy.
The Phase 1/2 trial will begin enrolling in the second half of 2026 to investigate the safety and efficacy of a one-time IOV-5001 treatment regimen without the use of IL-2. Cohorts include advanced colorectal, triple-negative, and estrogen receptor-low breast cancers, as well as other highly prevalent solid tumors representing more than 100,000 U.S. deaths annually.1
IOV-5001 is engineered to express IL-12 only within the tumor to enhance efficacy, particularly in cancers caused by immunologically cold tumors, and to tether IL-12 to the cell surface to prevent release into the bloodstream to optimize safety. IOV-5001 is designed to safely deliver significantly higher cell doses and improve upon an earlier secreted IL-12 TIL therapy that showed a 63% confirmed objective response rate.2
“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, Ph.D., J.D., Interim Chief Executive Officer and President of Iovance. “By tethering IL-12 to the TIL cell surface and targeting its activity inside the tumor, IOV-5001 is designed to activate cold tumors and open an entirely new frontier of massive opportunities for TIL cell therapy. We look forward to beginning patient enrollment in the second half of 2026.”
1. Surveillance, Epidemiology, and End Results Program Cancer Stat Facts (accessed May 2026).
2. Zhang L, Rosenberg SA, et al, Clin Cancer Res 2015;21(10):2278–2288.
About IOV-5001
IOV-5001 is an investigational second-generation TIL therapy engineered to express IL-12 only inside the tumor, where it is anchored to the TIL cell surface rather than released into the bloodstream. This design is intended to deliver the antitumor benefit seen with earlier IL-12 TIL therapies while avoiding systemic toxicity. In preclinical studies, IOV-5001 showed stronger antitumor activity and a healthier, more durable T cell profile than unmodified TIL therapies.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics, Inc. aims to be the global leader in innovating, developing, and delivering TIL therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance’s Amtagvi® is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. For more information, please visit www.iovance.com.
Amtagvi® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. All other trademarks and registered trademarks are the property of their respective owners.
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