Lion Biotechnologies announced the filing of an investigational new drug application with the U.S. Food and Drug Administration to conduct a phase 2 clinical trial of LN-144 for the treatment of patients with refractory metastatic melanoma.
LN-144, the company’s lead product candidate, is a ready-to-infuse autologous T-cell therapy utilizing tumor-infiltrating lymphocytes (TIL) derived from the patient’s own tumor. The treatment is based on a clinical Cooperative Research and Development Agreement with the National Cancer Institute and other academic institutions, according to a company press release.
TIL therapy also is being evaluated by physician-sponsored clinical trials at MD Anderson Cancer Center and H. Lee Moffitt Cancer Center & Research Institute, according to the release.
“This IND filing marks a significant milestone as we continue to advance our clinical programs in metastatic melanoma,” Elma Hawkins, PhD, president and CEO of Lion Biotechnologies, said in the release. “In previous studies conducted by the National Cancer Institute and other academic institutions, TIL therapy has demonstrated consistent and impressive objective response rates, including in patients who have exhausted other treatment options.”