Nanobiotix's partner, PharmaEngine, has launched a new 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.
About Nanobiotix and PharmaEngine Partnership
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.
About NANOBIOTIX - www.nanobiotix.com
Nanobiotix (Euronext: NANO / ISIN: FR0011341205) is a late clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer. The Company's first-in-class, proprietary technology, NanoXray, enhances radiotherapy energy with a view to provide a new, more efficient treatment for cancer patients.
NanoXray products are compatible with current radiotherapy treatments and are meant to treat potentially a wide variety of solid tumors including soft tissue sarcoma, head and neck cancers, liver cancers, prostate cancer, breast cancer, glioblastoma, etc., via multiple routes of administration.
Nanobiotix's lead product NBTXR3, based on NanoXray, is currently under clinical development for soft tissue sarcoma, head and neck cancer, prostate cancer, and liver cancers (HCC and liver metastases) as well as head and neck and rectal cancers under trial by PharmaEngine. The Company has filed in August 2016 for market approval (CE Marking) in Europe for its lead product NBTXR3. The Company has partnered with PharmaEngine for clinical development and commercialization of NBTXR3 in Asia.
Nanobiotix is listed on the regulated market of Euronext in Paris (ISIN: FR0011341205, Euronext ticker: NANO, Bloomberg: NANO: FP). The Company Headquarter is based in Paris, France. Affiliate in Cambridge, United States.
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This press release contains certain forward-looking statements concerning Nanobiotix and its business. Such forward-looking statements are based on assumptions that Nanobiotix considers to be reasonable. However, there can be no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in the reference document of Nanobiotix filed with the French Financial Markets Authority (Autorité des Marchés Financiers) under number D.16-0732 on July 22, 2016 (a copy of which is available on www.nanobiotix.com) and to the development of economic conditions, financial markets and the markets in which Nanobiotix operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Nanobiotix or not currently considered material by Nanobiotix. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Nanobiotix to be materially different from such forward-looking statements.
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Last updated on: 21/10/2016
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