On June 7, 2018 Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor infiltrating lymphocyte (TIL) technology, reported that the first patient was dosed in the ongoing C-144-01 Phase 2 trial of LN-144 (lifileucel) for the treatment of patients with metastatic melanoma at a clinical trial site in the United Kingdom (Press release, Iovance Biotherapeutics, JUN 7, 2018, View Source;p=RssLanding&cat=news&id=2353696 [SID1234527218]).
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"The dosing of the first patient with lifileucel in Europe for the treatment of metastatic melanoma marks an important milestone for Iovance and our global development plans as our European Union (EU) manufacturing is now able to support enrollment in that region," said Dr. Maria Fardis, PhD, MBA, president and chief executive officer of Iovance Biotherapeutics. "This is a major step forward and we are excited by the opportunity to offer more patients TIL therapy around the world."
In December 2017, the company announced that the Generation 2 manufacturing process, with a duration of 22 days, was selected and all studies were shifted to utilize that method of manufacturing. The company has manufacturing capability in both the US and EU. This is the first patient treated with TIL developed in an EU-based manufacturing facility.
C-144-01 is a Phase 2 multicenter study evaluating the safety and efficacy of autologous tumor infiltrating lymphocytes (lifileucel), Iovance’s lead product candidate for treatment of patients with metastatic melanoma. The study is currently enrolling in the United States and Europe. To date, Iovance has over 25 active clinical sites in the United States and Europe. The sample size for enrollment was increased to 85 for this study. Additional information on this study is available at www.clinicaltrials.gov using the identifier number NCT02360579.