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 that it will cooperate with The University of Texas MD Anderson Cancer Center, Houston TX, to work on NBTXR3, Nanobiotix’s lead product. NBTXR3 is a first-in-class product designed to destroy, when activated by radiotherapy, tumors and metastasis through physical cell death and to induce immunogenic cell death leading to specific activation of the immune system.
This project with MD Anderson, one of the world’s leading oncological research centers, will provide an unparalleled ability to develop pre-clinical data using NBTXR3 activated by radiotherapy plus anti-PD1 Nivolumab (murine version of Opdivo™).
Dr. Elsa Borghi, CMO, said: “The main objective of this collaboration is to analyze the micro environment of the tumors treated with NBTXR3 activated by radiotherapy, in order to increase and optimize the immune response.”
Dr. James Welsh, MD, Associate Professor, Department of Radiation Oncology, will be the Principal Investigator and lead the research program. The project between MD Anderson and Nanobiotix will take place over the course of two years and will evaluate the use of NBTXR3 activated by radiotherapy plus anti-PD1 Nivolumab (murine version of Opdivo™), provided by Bristol-Myers Squibb (BMS) in lung cancer models (in vitro and in vivo). Lung cancer is one of the most common cancer worldwide, accounting for 1.69 million deaths annually (WHO 2015).
The joint program will focus on 3 aims, leading to the maximization of NBTXR3 potential benefits in triggering an immune response:
- Evaluate the abscopal response through the combination of NBTXR3 plus an anti-PD1 antibody and radiation therapy in specific and resistent murine lung cancer models, in order to measure NBTXR3’s potential to control metastatic disease.
- Evaluate if NBTXR3 can further improve T cell activation for standard radiotherapy fractions compared to SBRT, notably by determining the STING activation in vitro in cancer cells with and without NBTXR3.
- Continue the characterization of the different mechanisms and types of cell death induced by NBTXR3 activated by radiation.
The joint program will also further explore the potential future use of NBTXR3 in immuno-oncology with checkpoint inhibitors, as well as its potential to control metastatic disease.
As announced in December 26, 2017, the Company has received from the Food and Drug Administration the approval of its Investigational New Drug (IND) application and should launch its first clinical trial combining NBTXR3 with immune checkpoint inhibitors in the U.S. in Q2 2018. This will be a multi-arm trial targeting a sub-population of advanced lung cancer patients and head and neck cancer patients.
NBTXR3 positioning in IO
Many IO combination strategies focus on ‘priming’ the tumor, which is now becoming a prerequisite of turning a “cold” tumor into a “hot” tumor.
Compared to other modalities that could be used for priming the tumor, NBTXR3 could have a number of advantages: the physical and universal mode of action that could be used widely across oncology, a one-time local injection and good fit within existing medical practice already used as a basis for cancer treatment, as well as a very good chronic safety profile and well-established manufacturing process.
Published preclinical and clinical data indicate that NBTXR3 could play a key role in oncology and could become a backbone in immuno-oncology.
Nanobiotix’s immuno-oncology combination program opens the door to new developments, potential new indications, and important value creation opportunities.
NBTXR3 is a first-in-class product designed to destroy, when activated by radiotherapy, tumors and metastasis through physical cell death and to immunogenic cell death leading to specific activation of the immune system.
NBTXR3 has a high degree of biocompatibility, requires one single administration before the whole radiotherapy treatment and has the ability to fit into current worldwide standards of radiation care.
NBTXR3 is being evaluated in head and neck cancer (locally advanced squamous cell carcinoma of the oral cavity or oropharynx), and the trial targets frail and elderly patients who have advanced cancer with very limited therapeutic options. The Phase I/II trial has already delivered very promising results regarding the local control of the tumors and a potential metastatic control through in situ vaccination.
Nanobiotix is running an Immuno-Oncology program with NBTXR3 that includes several studies. 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). This trial aims to expand the potential of NBTXR3, including using it to treat recurrent or metastatic disease.
The first market authorization process (CE Marking) is ongoing in Europe in the soft tissue sarcoma indication.
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.
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, NanoXray, 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.
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.