NANOBIOTIX TO PRESENT POSITIVE RESULTS FROM ITS PHASE II/III CLINICAL TRIAL OF NBTXR3 IN PATIENTS WITH SOFT TISSUE SARCOMA (STS) AND OTHER ONGOING PHASE I/II TRIALS AT UPCOMING ESMO AND ASTRO ANNUAL CONFERENCES
- Dr. Sylvie Bonvalot will present positive results from its Phase II/III clinical trial of NBTXR3 in soft tissue sarcoma (STS):
- Oral communication in the Sarcoma Proffered Paper presentation session at the European Society for Medical Oncology (ESMO) 2018 Congress
- Oral communication in the late-breaking abstract session at the American Society for Radiation Oncology (ASTRO) 60th Annual Meeting
- 7 additional posters on NBTXR3 clinical trials (liver cancers, head and neck cancers and immuno-oncology) will be presented during the ESMO 2018 Congress and the ASTRO 60th Annual Meeting
Paris, France and Cambridge, Massachusetts, September 26, 2018 – NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches in the treatment of cancer, announced today that detailed results of its phase II/III clinical trial of NBTXR3 in patients with soft tissue sarcoma (STS) will be presented by Dr. Sylvie Bonvalot, MD, PhD at the ESMO 2018 Congress in Munich (Germany) on the 19th of October 2018 during the Proffered Paper (Oral) presentation – Sarcoma and at the ASTRO 60th Annual Meeting in San Antonio (USA) on the 21st of October 2018 during the late-breaking abstract session.
European Society for Medical Oncology (ESMO) 2018 Congress
October 19 – 23, 2018 – Munich, Germany
- A phase II/III trial of hafnium oxide nanoparticles activated by radiotherapy in the treatment of locally advance soft tissue sarcoma of the extremity and trunk wall (LBA66)
Oral communication presented by Dr. Sylvie Bonvalot, MD, PhD (Paris, France) during the Proffered Paper presentation – Sarcoma
- Elderly patients with locally advanced head and neck squamous cell carcinoma treated with NBTXR3 nanoparticles activated by radiotherapy: a phase I trial (1058P)
Poster presented by Prof. Christophe Le Tourneau (Paris, France)
- Hepatocellular carcinoma and liver metastasis treated by hafnium oxide nanoparticles activated by stereotactic body radiation therapy (711P)
Poster presented by Dr. Marc Pracht (Rennes, France)
American Society for Radiation Oncology (ASTRO) 60th Annual Meeting
October 21 – 24, 2018 – San Antonio, Texas, United States
- Act.in.Sarc: An International Randomized Phase III Trial Evaluating Efficacy and Safety of First-in-Class NBTXR3 Hafnium Oxide Nanoparticles Activated by Preoperative Radiotherapy in Locally Advanced Soft Tissue Sarcoma (LBA7)
Oral communication presented by Dr. Sylvie Bonvalot, MD, PhD (Paris, France) during the late-breaking abstract session
- Hafnium Oxide Nanoparticles Activated by Radiation Therapy for the Treatment of Solid Tumors (SU_44_2434)
Poster presented by Prof. Juliette Thariat, MD, PhD (Caen, France)
- Hafnium Oxide Nanoparticles Activated by Radiation Therapy: An Innovative Approach for the Treatment of Liver Cancers (SU_13_2124)
Poster presented by Dr. Enrique Chajon Rodriguez, MD, PhD (Rennes, France)
- Elderly patients: NBTXR3 as a novel treatment option in locally advanced HNSCC (MO_10_2547)
Poster presented by Dr. Valentin Calugaru, MD (Paris, France)
- Exploratory Dosimetric Study of the Impact of the Pre-Radiation Therapy Intra Tumoral Injection of Hafnium Oxide Nanoparticles Along the Radiation Treatment of Extremity and Trunk Wall Soft Tissue Sarcomas (MO_15_2596)
Poster presented by Eliane Graulieres, PhD (Toulouse, France)
- Hafnium Oxide Nanoparticle Activated by Radiation Therapy Generates an Anti-Tumor Immune Response (1096)
Poster presented by Prof. Juliette Thariat, MD, PhD (Caen, France)
Date: 10.23 2018
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 and Nanobiotix believes has the ability to fit into current worldwide standards of radiation care.
Nanobiotix’s broad clinical program includes 10 patient population evaluated in 7 clinical trials.
In June 2018, Nanobiotix established human proof of concept for this first-in-class product in its Soft Tissue Sarcoma (STS) Phase III 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 that are unable to receive chemotherapy or cetuximab and have very limited therapeutic options. Promising results have been observed from the ongoing Phase I/II trial regarding the local control of the tumors.
Nanobiotix is running an Immuno-Oncology development program. In the United States, Nanobiotix has received approval from the U.S. Food and Drug Administration (FDA) 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).
The other ongoing NBTXR3 trials 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.
The first market authorization process (CE Marking) is ongoing in Europe in the STS indication.
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.
Nanobiotix’s first-in-class, proprietary lead technology, NanoXray, aims to expand radiotherapy benefits for millions of cancer patients. Furthermore, Nanobiotix’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.
France – Springbok Consultants
United States – RooneyPartners
This press release contains certain forward-looking statements concerning Nanobiotix and its business prospects, including statements regarding the clinical development of its product candidates, including NBTXR3, and timing and developments regarding its Phase II/III clinical trial of NBTXR3 in patients with soft tissue sarcoma. 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 (copies of which are 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.
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. Forward-looking statements speak only as of the date of this release, and Nanobiotix undertakes no obligation to update or revise these statements, except as may be required by law.