[NBC-1TV H. J Yook]NANOBIOTIX (Euronext: NANO), a clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer, announces today that its lead compound NBTXR3 has received authorization from the French Medicine Agency, ANSM[1], to start a clinical trial in patients with locally advanced cancers of the oral cavity or oropharynx (head and neck cancer), at the Institut Curie, Paris, France, a French leading cancer treatment center. This represents a second indication for NBTXR3 which is also in clinical trials for soft tissue sarcoma.

The phase I trial will be an open-label non-randomized, dose escalation study of safety and tolerability evaluation of NBTXR3. The product will be implanted by intra-arterial (IA) or intra-tumor (IT) injection, and activated by high precision radiation therapy (Intensity-modulated radiation therapy - IMRT) delivered as per current medical practice. Patients with locally advanced squamous cell carcinoma of the oral cavity or oropharynx constitute the targeted population which includes frail and elderly patients. Two different administration schedules of NBTXR3 will be investigated simultaneously in 2 different groups of patients. Allocation of patients to the intra-tumor injection or intra-arterial injection depends on the patient and tumor singularity. Based on the observed safety, the recommended doses for further evaluation of NBTXR3 as intra-arterial or intra-tumor injection with radiotherapy will be selected.

The secondary objectives of the study include assessment of the tumor Response Rate and complete Response Rate by MRI, and the evaluation of local and general Progression Free Survival of NBTXR3. Furthermore, the feasibility of local administration, either intra-tumor or intra-arterial injection of NBTXR3, then activated by radiotherapy will be evaluated.

Approximately, 24 patients are expected to be treated in any schedule (IT or IA) of the trial, with a total of maximum 48 patients.

“The approval from ANSM to start a second clinical trial with NBTXR3 in Head and Neck cancer patients is a major milestone for Nanobiotix,” said Laurent Levy, PhD, CEO of Nanobiotix. “This follows the recent positive intermediate results from the clinical study of NBTXR3 in advanced Soft Tissue Sarcoma patients, which continues the regulatory pathway to market.”