- Collaboration will initially support nine new phase I/II clinical trials with Nanobiotix’s first-in-class agent NBTXR3 for use in treating six cancer types – head and neck, pancreatic, thoracic, lung, gastrointestinal and genitourinary cancers – involving around 340 patients
- Most of the trials are expected to be launched in 2019
- Collaboration includes a $12M total investment from Nanobiotix
Paris, France, Cambridge, Massachusetts (USA) and Houston, Texas (USA), January 7 2019 – NANOBIOTIX (Euronext : NANO – ISIN : FR0011341205) and The University of Texas MD Anderson Cancer Center today announced a large-scale, comprehensive clinical research collaboration to evaluate innovative strategies for treating patients with head and neck, pancreatic, thoracic, lung, gastrointestinal and genitourinary cancers.
The collaboration will expand clinical development of NBTXR3, a first-in-class agent designed to physically destroy cancer cells when activated by radiotherapy and to activate the immune system for both local control and systemic disease treatment.
MD Anderson will initially conduct the launch of nine new phase I/II clinical trials – involving around 340 patients – focused on evaluating the potential clinical benefit of NBTXR3 when activated by radiotherapy, either as a monotherapy or in combination with checkpoint inhibitors. The planned trials also will look at various disease stages, including low-risk/good prognostic patients, locally advanced disease, and metastatic disease. The trials will study NBTXR3 across different radiation modalities such as radiation, re-irradiation, and compare different levels of intensity of radiation, to evaluate whether the addition of NBTXR3 to radiotherapy will improve progression-free survival, loco-regional control, quality of life and organ preservation.
Dr. Thomas Morris, Global Head of Development, Nanobiotix, said “It is important for Nanobiotix to collaborate with academic institutions to develop a broad spectrum of clinical trials in an expedited fashion. This is a tremendous opportunity to strengthen our scientific and clinical understanding of the potential of NBTXR3 across the wide range of cancers treated with radiotherapy, with the goal of benefitting patients by applying novel research and bringing forward an innovative therapy. The collaboration between Nanobiotix and MD Anderson expands the number of NBTXR3 clinical trials to 16, illustrating our dedication to identify more effective treatments for cancer patients.”
As part of the funding scheme for this collaboration, part of the payment will be made at the start of the collaboration. Other parts will be paid during development and the balance in case of FDA registration for a total of $12M investment.
This new collaboration between Nanobiotix and MD Anderson follows up the immunotherapeutic pre-clinical research collaboration, launched in April 2018, in lung cancer to explore NBTXR3 potential in immuno-oncology with checkpoint inhibitors, as well as its potential to control metastatic disease.
NBTXR3 is a first-in-class product designed to destroy, when activated by radiotherapy:
- tumors through physical cell death
- metastasis due to immunogenic cell death leading to activation of the immune system
NBTXR3 has a high degree of biocompatibility, requires one single administration before the whole radiotherapy treatment.
NBTXR3 is a late clinical stage product which has shown the potential for clinical benefit in advanced STS phase III randomized clinical trial.
NBTXR3 is actively being evaluated in head and neck cancer with locally advanced squamous cell carcinoma of the oral cavity or oropharynx in elderly and frail patients unable to receive chemotherapy. The other ongoing studies are treating patients with liver cancers (hepatocellular carcinoma and liver metastasis), locally advanced or unresectable rectal cancer in combination with chemotherapy, head and neck cancer in combination with concurrent chemotherapy, and prostate adenocarcinoma.
Nanobiotix is also running an Immuno-Oncology development program. In the U.S., the Company received the FDA’s approval to launch a clinical study of NBTXR3 activated by radiotherapy in combination with anti-PD1 antibodies in lung, and head and neck cancer patients (head and neck squamous cell carcinoma and non-small cell lung cancer).
About NANOBIOTIX – www.nanobiotix.com
Incorporated in 2003, Nanobiotix is a leading, late clinical-stage nanomedicine company pioneering new approaches to significantly change patient outcomes by bringing nanophysics to the heart of the cell.
The Nanobiotix philosophy is one rooted in designing pioneer physical based approaches to bring highly effective and generalized solutions to address high unmet medical needs and challenges.
The Company’s first-in-class, proprietary lead technology, NBTXR3 aims to expand radiotherapy benefits for millions of cancer patients. Furthermore, the Company’s Immuno-Oncology program has the potential to bring a new dimension to cancer immunotherapies.
Nanobiotix is listed on the regulated market of Euronext in Paris (Euronext: NANO / ISIN: FR0011341205; Bloomberg: NANO: FP). The Company’s Headquarters are based in Paris, France, with a U.S. affiliate in Cambridge, MA, and European affiliates in Spain and Germany.
About MD Anderson
The University of Texas MD Anderson Cancer Center in Houston ranks as one of the world’s most respected centers focused on cancer patient care, research, education and prevention. The institution’s sole mission is to end cancer for patients and their families around the world. MD Anderson is one of only 49 comprehensive cancer centers designated by the National Cancer Institute (NCI). MD Anderson is ranked No.1 for cancer care in U.S. News & World Report’s “Best Hospitals” survey. It has ranked as one of the nation’s top two hospitals for cancer care since the survey began in 1990, and has ranked first 14 times in the last 17 years. MD Anderson receives a cancer center support grant from the NCI of the National Institutes of Health (P30 CA016672).
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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.17-0470 on April 28, 2017 as well as in its 2017 annual financial report filed with the French Financial Markets Authority on March 29, 2018 (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.