PARIS & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Regulatory News:
NANOBIOTIX (Paris:NANO) (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, today announced the expansion and acceleration of its clinical development activities. These include:
- Acceleration of the head and neck cancer program. Phase I/II data will be presented at ASCO in June
- Expansion of Nanobiotix’s Immuno-Oncology program into patients focused on the objective of turning cold tumors into hot tumors. Nanobiotix will present the first clinical data from this program mid year
NBTXR3: New programs and upcoming data
Presentation of the Phase I/II data of Nanobiotix’s European head and neck trial with NBTXR3 at the American Society of Clinical Oncology (ASCO) Annual Meeting in June. Nanobiotix is preparing the next clinical trials of the head and neck cancer program. Based on the value of the data to be presented in June, the Company will determine the fastest pathway to the U.S. and European markets.
Presentation of the first clinical data from Nanobiotix’s new clinical program in Immuno-Oncology mid year. Based on the preclinical proof of concept presented in November 2016 at the Society for Immunotherapy of Cancer (SITC), Nanobiotix initiated an exploratory clinical biomarkers study in soft tissue sarcoma patients (data from Nanobiotix’s phase II/III trial in soft tissues sarcoma). This trial investigates whether NBTXR3 could play a role in Immuno-Oncology by turning cold tumors into hot tumors (compared with radiotherapy alone).
Continuation of the Phase II/III trial in soft tissue sarcoma with NBTXR3, recommended by an Independent Data Monitoring Committee (IDMC), which evaluated the safety and efficacy data of two thirds of the patients in the “Act.in.Sarc” study. As planned and communicated, the completion of the patient recruitment process for this trial is expected by the end of Q2 2017, with data, except for long-term follow-up, expected by the end of 2017.
Nanobiotix will continue to develop NBTXR3 in other indications: These include prostate cancer (Phase I/II), liver cancers (Hepatocellular Phase I/II and liver cancer metastases Phase I/II), rectum cancer (Phase I/II – by PharmaEngine) and head and neck cancers in patients receiving chemotherapy (Phase I/II – by PharmaEngine). In H2 2017, the prostate cancer indication should deliver preliminary safety and feasibility data. Additionally, before the end of 2017, Nanobiotix aims to complete patient recruitment for the Phase I part in liver cancers, and may proceed to select the patient population for the dose-expansion part of the trial (Phase II).
In parallel, Nanobiotix is accelerating its market preparations for NBTXR3’s launch on the European market. The first approval (CE marking) in Europe is expected in H2 2017.
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.
NBTXR3 is being evaluated in: soft tissue sarcoma (STS), head and neck cancers, prostate cancer, and liver cancers (primary and metastases). Additionally, head and neck cancer and rectal cancer trials led by Nanobiotix’s Taiwanese partner, PharmaEngine, are underway in the Asia Pacific region. The Company has filed in August 2016 for market approval (CE Marking) in Europe for its lead product NBTXR3.
The Company started in 2016 a new preclinical research program in Immuno-oncology with its lead product NBTXR3, which could have the potential to bring a new dimension to cancer immunotherapies.
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.
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 update of the reference document of Nanobiotix filed with the French Financial Markets Authority (Autorité des Marchés Financiers) under number D.16-0732-A01 on December 27, 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.
This press release and the information that it contains do not constitute an offer to sell or subscribe for, or a solicitation of an offer to purchase or subscribe for, Nanobiotix shares in any country. At the moment NBTXR3 does not bear a CE mark and is not permitted to be placed on the market or put into service until NBTXR3 has obtained a CE mark.