Obsidian Gets Fast Track for OBX-115

FDA has granted Obsidian Therapeutics a fast track designation for OBX-115, an engineered tumor-derived autologous T cell immunotherapy in combination with a pharmacologically regulatable membrane-bound IL15 for treating patients with metastatic or locally advanced melanoma that is refractory to or has relapsed after PD-1/PD-L1–based immune checkpoint inhibitors.

The designation was based on data from a dose-finding study that showed OBX-115 has a “promising efficacy profile” without interleukin-2 administration, according to the company. The study showed a 44% objective response rate across all dose-level cohorts, Obsidian says, adding that it also demonstrated 100% disease control rate, tumor burden reduction in all patients, and 75% progression-free survival at 24 weeks.

OBX-115 is also being investigated in a multicenter trial for treatingnon-small cell lung cancer (NCT06060613).