Iovance Biotherapeutics, Inc.

Iovance Biotherapeutics, Inc. is a commercial-stage biopharmaceutical company focused on treating cancer through tumor infiltrating lymphocyte (TIL) cell therapies. The company aims to be a global leader in innovating, developing, and delivering these therapies for patients with solid tumor cancers. TIL cell therapies work by using an individual's immune system to recognize and destroy cancer cells unique to each patient. These therapies are manufactured using centralized, scalable, and proprietary processes that rejuvenate and multiply each patient's polyclonal T cells into billions. Iovance was founded to expand upon TIL cell therapy initially developed at academic research centers, including the National Cancer Institute (NCI). The company's multi-center trials, scalable manufacturing, regulatory approvals, and commercial infrastructure have made TIL cell therapy a commercially viable treatment accessible to thousands of cancer patients. Iovance's commercial products include Amtagvi® (lifileucel) and Proleukin® (aldesleukin), an interleukin-2 (IL-2) product used in the Amtagvi® treatment regimen and other applications. Amtagvi® is the first one-time, individualized T cell therapy for a solid tumor cancer, specifically for adult patients with previously treated advanced, unresectable, or metastatic melanoma. It is administered as part of a regimen that includes lymphodepletion and a short course of Proleukin®. Amtagvi® is approved in the U.S. and Canada. The company plans to launch into additional markets with a high prevalence of advanced melanoma, with potential approvals pending in the United Kingdom (UK) and Australia in the first half of 2026, and Switzerland in 2027. In the European Union (EU), Iovance withdrew its initial marketing authorization application (MAA) in July 2025 and is working with the European Medicines Agency (EMA) to resubmit a centralized MAA in 2026.