FDA Oks Nanobiotix's First Immuno-Oncology Trial

(RTTNews) - Nanobiotix announced the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) Application for NBTXR3, a first-in-class nanoparticle designed for direct injection into cancerous tumors, activated by stereotactic ablative radiotherapy (SABR) and administered in combination with an anti-PD1 antibody (nivolumab or pembrolizumab).

The IND approval enables Nanobiotix to initiate NBTXR3-1100, a Phase I/II prospective, multi-center, open-label, and non-randomized clinical trial evaluating the efficacy and safety of NBTXR3 activated by SABR combined with checkpoint inhibitors (nivolumab or pembrolizumab).

NBTXR3-1100 includes three cohorts of patients with recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC), or with metastatic non-small cell lung cancer (NSCLC). The study will be conducted in two consecutive phases. The first of these will be dose escalation, followed by a dose expansion phase. The study will seek to enroll between 36 to 72 patients in Phase I and 40 patients in Phase II.

The NBTXR3-1100 trial will be led by coordinating investigator Tanguy Seiwert, M.D., of The University of Chicago Medical Center, and principal investigator Jared Weiss, M.D., of The University of North Carolina - Chapel Hill.

The first patient first visit in the potentially paradigm changing trial is expected in the second-quarter 2018 with with first expected results in the summer of 2019.