On April 2, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that first patient has been dosed in Cohort 4, the pivotal cohort of the innovaTIL-01 (C-144-01) study of lifileucel (Press release, Iovance Biotherapeutics, APR 2, 2019, View Source;p=RssLanding&cat=news&id=2393137 [SID1234534888]). Cohort 4 is designed to enroll 75 patients with advanced melanoma.

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"Dosing of the first patient in Cohort 4, the pivotal arm of our melanoma program, is a significant step toward registration of TIL therapy," commented Maria Fardis, Ph.D., president and chief executive officer of Iovance. "Complete enrollment of this cohort is expected in early 2020 and we remain on track to file a Biologics License Application for regulatory approval of lifileucel in late 2020."

InnovaTIL-01 (NCT02360579) is a pivotal phase 2 global multicenter study evaluating the safety and efficacy of Iovance’s autologous lifileucel TIL therapy for treatment of patients with metastatic melanoma. The study is currently enrolling in the United States and Europe. To date, Iovance has activated 39 clinical sites in the United States and Europe. Additional information on this study is available at View Source