Lion Biotechnologies Inc. on Monday announced it has opened enrollment in a Phase 2 clinical trial of its lead product candidate, LN-144, for the treatment of refractory metastatic melanoma.
The single-arm study will be conducted at up to five sites and is anticipated to enroll approximately 20 patients with metastatic melanoma whose disease has progressed following treatment with at least one systemic therapy. The purpose of the study is to evaluate the safety, efficacy and feasibility of autologous tumor-infiltrating lymphocyte (TIL) infusion.
"We are encouraged by the consistently robust data from previous studies of TIL therapy in melanoma treatment at leading cancer centers,” Lion CEO and President Elma Hawkins said. “As we continue to evaluate the safety and efficacy of LN-144 in this study, we also look forward to assessing the feasibility of manufacturing TIL on a commercial scale, with the goal of ensuring that this promising therapy can be available for many patients who may benefit from it."
Lion Biotechnologies is a clinical-stage biotechnology company that is dedicated to the development of immunotherapy products for the treatment of various cancers. The company's lead product candidate is based on a clinical Cooperative Research and Development Agreement with the National Cancer Institute.