Lion Biotechnologies, Inc. (LBIO), announced that the FDA has allowed its investigational new drug (IND) application to initiate a Phase 2 study of its lead product candidate, LN-144, in the treatment of refractory metastatic melanoma.
The single-arm clinical trial will be conducted at up to five sites in a total of 20 evaluable patients with stage 4 metastatic melanoma, who have previously progressed following systemic treatment. The objectives of the study are to assess safety, feasibility and anti-tumor activity, as well as various other indicators of efficacy.
“We are pleased to have received FDA clearance to begin a new Phase 2 study of LN-144 in patients with refractory metastatic melanoma, who urgently need new treatment options,” said Elma Hawkins, PhD, Lion’s president and chief executive officer. “In previous studies, TIL therapy has demonstrated impressive objective response rates, including in patients who had previously failed treatment with various biologic treatments. We look forward to further investigating the safety and efficacy of LN-144 in this new study.”