Iovance Biotherapeutics, Inc.
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- Iovance Biotherapeutics, Inc. is a pioneering biotechnology firm focused on developing and commercializing cell therapies that leverage a patient's own immune system to combat cancer. Headquartered in San Carlos, California, the company specializes in tumor-infiltrating lymphocyte (TIL) technology, aiming to deliver personalized treatment options for various advanced solid tumor cancers. The company's lead product, AMTAGVI (lifileucel), received accelerated approval from the U.S. Food and Drug Administration (FDA) in February 2024 for adults with unresectable or metastatic melanoma who have undergone prior treatments. This marked a significant milestone as the first FDA-approved T-cell therapy for a solid tumor indication. Iovance's revenue model primarily revolves around the sale of its innovative therapies like AMTAGVI and its interleukin-2 product, Proleukin, which supports the AMTAGVI treatment regimen. The company generated approximately $250.43 million in revenue over the last twelve months, with a substantial increase driven by the commercial launch of AMTAGVI in 2024. Iovance continues to advance its robust clinical pipeline, investigating TIL therapy across multiple solid tumor types. Key ongoing clinical programs include further studies of lifileucel (Amtagvi) for advanced melanoma, including a Phase 3 trial (TILVANCE-301) in combination with pembrolizumab, and a registrational Phase 2 study (IOV-LUN-202) for advanced non-small cell lung cancer (NSCLC). Additionally, the pipeline features next-generation TIL therapies like IOV-4001, a PD-1 inactivated TIL therapy, and IOV-3001, a modified IL-2 analog, both in early to mid-stage development with anticipated clinical data in 2026. The company also plans an Investigational New Drug (IND) submission in early 2026 for IOV-5001, a genetically engineered, inducible, and tethered interleukin-12 TIL therapy, targeting solid tumors with high unmet needs. Iovance Biotherapeutics aims to be a global leader in TIL therapy, driven by its unique patient-specific cell therapy platform designed to recognize and attack diverse cancer cells. The company emphasizes innovation, patient-centricity, and a pioneering approach to transform cancer treatment, with a strong focus on expanding market reach into new territories such as the UK, EU, and Canada in 2025. Founded in 2007, Iovance was previously known as Lion Biotechnologies, Inc. before adopting its current name in 2017.
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