Nanobiotix Partner PharmaEngine Launches NBTXR3 Clinical Trial in Head and Neck Cancers in Asia

Seventh clinical trial with NBTXR3 in a new population of patients with head and neck cancers treated with radiotherapy plus chemotherapy

Paris, France, and Cambridge, Massachusetts, USA, October 20, 2016 – NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer, today announced that its Asia-Pacific partner, PharmaEngine, has dosed its first patient in a new Phase I/II trial in patients with head and neck cancers patient receiving radiotherapy plus chemotherapy, this October. The trial is evaluating the optimal dose, safety and preliminary efficacy of Nanobiotix’s lead product. 

PharmaEngine has broadened its development plan for NBTXR3 by launching this new trial in Asia targeting a new and larger head and neck cancer patient population. This follows the successful results from the European Phase I/II trial in patients with head and neck cancers presented in July 2016 by Nanobiotix demonstrating promising signs of tumor volume response and excellent signs of safety.

NBTXR3 is now addressing a wide range of head and neck cancers patients. The study in Asia by PharmaEngine addresses patients receiving chemotherapy (cisplatin) plus radiotherapy whereas the study in Europe by Nanobiotix covers patients which are not eligible for chemotherapy plus radiotherapy and only receive radiotherapy.

Head and neck cancers include cancers of the oral cavity, tongue and oropharynx. These cancers are a major concern for public health, with a high worldwide prevalence, particularly in Asia, where the patient population is expanding.

This joint approach by Nanobiotix and PharmaEngine supports the preparation of a development plan for head and neck cancers registration studies with NBTXR3 potentially in Europe, in the US and in Asia. Nanobiotix will provide this next year.

Laurent Levy, CEO of Nanobiotix commented: “This seventh trial opens significant potential market opportunities for NBTRX3 by broadening the potential treatable population of head and neck cancer patients for whom NBTXR3 may significantly improve quality of life.”

About the PharmaEngine Head and Neck Phase I/II Trial in Asia

This new trial is an open-label, single arm, non-randomized study for patients with head and neck cancers. The primary objectives of the study are to determine the optimal dose, safety and preliminary efficacy of NBTXR3 through intra-tumor injection in combination with concurrent chemoradiotherapy (CCRT). The first patient was injected with NBTXR3 in October 2016 and the maximum number of patients that will be enrolled in the study is 42.