Nanotechnology Now

Our NanoNews Digest Sponsors
Heifer International

Wikipedia Affiliate Button

Home > Press > Nanotech company granted FDA Fast Track for treatment of head & neck cancer

Abstract:
•The U.S. Food and Drug Administration reviewed the Company’s request for Fast Track designation and concluded that investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced head and neck squamous cell cancer who are not eligible for platinum-based chemotherapy meets the criteria for a Fast Track development program
•Fast Track designation for NBTXR3 in head and neck cancer underscores the urgent need for potential new treatment options for patients in this population

Nanotech company granted FDA Fast Track for treatment of head & neck cancer

Paris, France and Cambridge, MA | Posted on February 10th, 2020

The FDA’s decision to grant Fast Track designation is not only important for the development of NBTXR3 activated by radiation therapy, which is now eligible for accelerated approval and priority review, but even more critically it underscores the unmet needs and limited options of patients with locally advanced head and neck cancer. The available public data and our development plans moving forward give us confidence that NBTXR3 could significantly improve treatment outcomes for patients. Fast Track development in head and neck cancer is a major step forward.” – Laurent Levy, CEO of Nanobiotix

Paris, France ; Cambridge, Massachusetts (USA) ; February 10, 2020 - NANOBIOTIX (Euronext: NANO - ISIN: FR0011341205 – the “Company”), a clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced head and neck squamous cell cancer who are not eligible for platinum-based chemotherapy.



Fast Track is a process designed to facilitate the development and accelerate the review of drugs for serious conditions and that have the potential to address unmet medical needs. The purpose is to expedite the availability of new treatment options for patients.



A product that receives Fast Track designation is eligible for[1]:

More frequent meetings with the FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval
More frequent written communication from the FDA about such things as the design of proposed clinical trials and the use of biomarkers
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
Rolling Review, which means that a drug company can submit completed sections of the New Drug Application (NDA) for review by the FDA, rather than waiting until the entire NDA is completed before the application can be reviewed

####

About Nanobiotix
Incorporated in 2003, Nanobiotix is a leading, 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 rooted in designing pioneering, physical-based approaches to bring highly effective and generalized solutions to address unmet medical needs and challenges.



Nanobiotix’s first-in-class, proprietary lead technology, NBTXR3, aims to expand radiotherapy benefits for millions of cancer patients. 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 in Paris, France, with a US affiliate in Cambridge, MA, and European affiliates in France, Spain and Germany

About NBTXR3

NBTXR3 is a first-in-class product designed to destroy tumors through physical cell death when activated by radiotherapy. NBTXR3 has a high degree of biocompatibility, requires one single administration before the first radiotherapy treatment session, and has the ability to fit into current worldwide radiotherapy radiation therapy standards of care. The physical mode of action of NBTXR3 makes it applicable across solid tumors such as lung, prostate, liver, glioblastoma, and breast cancers.



NBTXR3 is actively being evaluated locally advanced head and neck squamous cell carcinoma (HNSCC) of the oral cavity or oropharynx in elderly and frail patients unable to receive chemotherapy or cetuximab with limited therapeutic options. Promising results have been observed in the phase I trial regarding local control. In the United States, the company has started the regulatory process for the clinical authorization of a phase II/III trial in locally advanced head and neck cancers.



Nanobiotix is also running an Immuno-Oncology development program. The Company received FDA approval to launch a clinical trial of NBTXR3 activated by radiotherapy in combination with anti-PD-1 antibodies in locoregional recurrent (LRR) or recurrent and metastatic (R/M) HNSCC amenable to re-irradiation of the HN and lung or liver metastases (mets)from any primary cancer eligible for anti-PD-1.



The other ongoing NBTXR3 trials are treating patients with hepatocellular carcinoma (HCC) or liver metastases, locally advanced or unresectable rectal cancer in combination with chemotherapy, head and neck cancer in combination with concurrent chemotherapy, and prostate adenocarcinoma. Furthermore, the company has a large-scale, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center (9 new phase I/II clinical trials in the United States) to evaluate NBTXR3 across head and neck, pancreatic, thoracic, lung, gastrointestinal and genitourinary cancers.

Disclaimer



This press release contains certain forward-looking statements concerning Nanobiotix and its business, including its prospects and product candidate development. 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 registered with the French Financial Markets Authority (Autorité des Marchés Financiers) under number R.19-018 on April 30, 2019 (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.

For more information, please click here

Contacts:
Nanobiotix





Communications Department

Brandon Owens

VP, Communications

+1 (617) 852-4835





Pascalyne Wilson

Senior Manager, Corporate Marketing

+33 (0) 1 70 61 00 18







Investor Relations Department
Noel Kurdi (US)

Director, Investor Relations

+1 (646) 241-4400





Ricky Bhajun (EU)

Senior Manager, Investor Relations

+33 (0)1 79 97 29 99






Media Relations





France – TBWA Corporate

Pauline Richaud

+ 33 (0) 437 47 36 42







US – RooneyPartners

Marion Janic

+1 (212) 223-4017

Copyright © Nanobiotix

If you have a comment, please Contact us.

Issuers of news releases, not 7th Wave, Inc. or Nanotechnology Now, are solely responsible for the accuracy of the content.

Bookmark:
Delicious Digg Newsvine Google Yahoo Reddit Magnoliacom Furl Facebook

Related News Press

News and information

A step ahead in the race toward ultrafast imaging of single particles April 9th, 2020

House cleaning on the nanoscale: FAU scientists develop method for cleaning surfaces at the nanoscale April 8th, 2020

A twist connecting magnetism and electronic-band topology: Combined optical and torque measurements establish the microscopic mechanism linking magnetism and electronic-band topology in a Dirac material April 7th, 2020

New measurements reveal evidence of elusive particles in a newly-discovered superconductor: Material may be natural home to quasiparticle hiding for decades April 3rd, 2020

Govt.-Legislation/Regulation/Funding/Policy

A step ahead in the race toward ultrafast imaging of single particles April 9th, 2020

A twist connecting magnetism and electronic-band topology: Combined optical and torque measurements establish the microscopic mechanism linking magnetism and electronic-band topology in a Dirac material April 7th, 2020

A combined optical transmitter and receiver: Bidirectional optical signal transmission between two identical devices using perovskite diodes April 3rd, 2020

3D reconstructions of individual nanoparticles: Liquid phase electron microscopy illuminates 3D atomic structures of platinum nanoparticles, advancing full control of nanoengineering April 3rd, 2020

Possible Futures

A step ahead in the race toward ultrafast imaging of single particles April 9th, 2020

House cleaning on the nanoscale: FAU scientists develop method for cleaning surfaces at the nanoscale April 8th, 2020

A twist connecting magnetism and electronic-band topology: Combined optical and torque measurements establish the microscopic mechanism linking magnetism and electronic-band topology in a Dirac material April 7th, 2020

New measurements reveal evidence of elusive particles in a newly-discovered superconductor: Material may be natural home to quasiparticle hiding for decades April 3rd, 2020

Nanomedicine

3D reconstructions of individual nanoparticles: Liquid phase electron microscopy illuminates 3D atomic structures of platinum nanoparticles, advancing full control of nanoengineering April 3rd, 2020

O-FIB: Far-field-induced near-field breakdown for direct nanowriting in an atmospheric environment March 20th, 2020

Tokai scientists create the world's first electronic skin-based sensor for heatstroke detection March 17th, 2020

March 17th, 2020

Announcements

A step ahead in the race toward ultrafast imaging of single particles April 9th, 2020

House cleaning on the nanoscale: FAU scientists develop method for cleaning surfaces at the nanoscale April 8th, 2020

A twist connecting magnetism and electronic-band topology: Combined optical and torque measurements establish the microscopic mechanism linking magnetism and electronic-band topology in a Dirac material April 7th, 2020

New measurements reveal evidence of elusive particles in a newly-discovered superconductor: Material may be natural home to quasiparticle hiding for decades April 3rd, 2020

Nanobiotechnology

3D reconstructions of individual nanoparticles: Liquid phase electron microscopy illuminates 3D atomic structures of platinum nanoparticles, advancing full control of nanoengineering April 3rd, 2020

March 17th, 2020

Arrowhead Pharmaceuticals Reports Inducement Grants under NASDAQ Marketplace Rule 5635(c)(4) March 17th, 2020

Curcumin is the spice of life when delivered via tiny nanoparticles: Treatment for Alzheimer's and genital herpes March 6th, 2020

NanoNews-Digest
The latest news from around the world, FREE



  Premium Products
NanoNews-Custom
Only the news you want to read!
 Learn More
NanoStrategies
Full-service, expert consulting
 Learn More











ASP
Nanotechnology Now Featured Books




NNN

The Hunger Project