US FDA APPROVES NANOBIOTIX’S FIRST IMMUNO-ONCOLOGY TRIAL: A PHASE I/II STUDY OF NBTXR3 ACTIVATED BY RADIATION THERAPY (SABR) FOR PATIENTS WITH NON-SMALL CELL LUNG CANCER OR HEAD AND NECK SQUAMOUS CELL CARCINOMA CANCER TREATED WITH AN ANTI-PD1 ANTIBODY (NIVOLUMAB OR PEMBROLIZUMAB)
First Nanobiotix immuno-oncology trial will be conducted in the U.S.
Multi-arm trial targets sub-population of advanced and metastatic lung (NSCLC), and head and neck cancer patients (HNSCC).
Evaluation of NBTXR3’s potential to turn anti-PD1 inhibitor (nivolumab or pembrolizumad) non-responders at 12 weeks into responders
Trial will also include Head & Neck (HNSCC) cancer patients that are anti-PD1 inhibitor naïve
Expands the potential for NBTXR3 to help locoregionally recurrent or metastatic disease patients through reirradiation or treatment in a single lung or liver metastase
Laurent Levy, CEO of Nanobiotix, stated: “The FDA’s approval of Nanobiotix’s IND application for this trial is a major milestone for our Company.We’re ready and excited to launch our first immuno-oncology clinical trial in the U.S. combining NBTXR3 with a checkpoint inhibitor. Advancing our demonstration of NBTXR3’s potential to turn checkpoint inhibitor non-responders into responders could be game-changing, and the approach could address the unmet medical needs of a significant number of patients. Based on existing pre-clinical and clinical data, NBTXR3 could become a backbone in immuno-oncology.”.
About NBTXR3
NBTXR3 is an injectable aqueous suspension of hafnium oxide nanoparticles designed as an innovative therapeutic agent for the treatment of solid tumors, currently in clinical development by Nanobiotix. Once injected intratumorally, NBTXR3 can deposit high energy within tumors only when activated by an ionizing radiation source, notably radiotherapy. Upon activation, the high energy radiation is physically designed to kill the tumor cells by triggering DNA damage and cell destruction and improve clinical outcomes.
About Nanobiotix
Nanobiotix is listed on the regulated market of Euronext in Paris (ISIN: FR0011341205, Euronext ticker: NANO, Bloomberg: NANO: FP). The Company’s Headquarters are based in Paris, France, with a U.S. affiliate in Cambridge, Massachusetts.
