Nanobiotix Asia Partner PharmaEngine Launches Clinical Trial in Head, Neck Cancers

Nanobiotix PharmaEngine

PharmaEngine, the Asia-Pacific partner of Nanobiotix (Euronext:Nano), has dosed its first patient in a new Phase I/II trial in patients with head and neck cancers patients receiving radiotherapy plus chemotherapy in October.

The trial, according to Nanobiotix, is evaluating the optimal dose, safety and preliminary efficacy of Nanobiotix’s lead product. Nanobiotix is a late clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer

In a statement, Nanobiotix said 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.”

The 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.

PharmaEngine has a licensing agreement with Nanobiotix for the development and commercialization of Nanobiotix’s lead product, NBTXR3, in Asia-Pacific. As part of this agreement, Nanobiotix has already received upfront payments and milestone payments.

The Company is eligible to receive further development and commercialization milestone payments. Collectively, these payments may amount to a total of US$56 million plus tiered, up to double-digit royalties on all net product sales in the Asian-Pacific region. –