Pharmaceutical Business review

Lion gets exclusive license from NIH to develop TIL Therapy for metastatic melanoma

The exclusive license was received through an amendment to Lion’s previously granted, non-exclusive, worldwide license to certain NIH issued and pending patent applications for the use of TIL in metastatic melanoma.

Currently, many clinical trials of TIL therapy are being carried out at a number of institutions including the National Cancer Institute (NCI) and Moffitt Cancer Center.

In January 2015, the company secured clearance from the US Food and Drug Administration (FDA) to begin an additional Phase Iii trial in refractory metastatic melanoma.

Lion president and chief executive officer Elma Hawkins said: "We are pleased to have further strengthened our relationship with the NIH through this exclusive licensing agreement.

"Having exclusivity meaningfully de-risks our development and commercialization efforts, putting us in an even stronger position to investigate TIL therapy in the treatment of metastatic melanoma."

Lion is engaged in the development of T cells and engineered T cells to treat various cancers

LN-144, the company’s lead product candidate, is a ready-to-infuse, autologous T-cell therapy using TIL to treat patients with metastatic melanoma, and is based on a clinical Cooperative Research and Development Agreement with the National Cancer Institute.