Satellite Banner
Genomics
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Nanobiotix Sees Clinical Advance in STS Pilot Trial with Lead Product, NBTXR3

Published: Tuesday, February 11, 2014
Last Updated: Tuesday, February 11, 2014
Bookmark and Share
Market development plan outlined for earlier potential launch in 2016.

Nanobiotix has announced its development plan for the CE marking of NBTXR3, the first product from the NanoXray pipeline.

The positive results from the pilot phase of NBTXR3 in patients with advanced soft tissue sarcoma (STS), allow Nanobiotix to finalize and to announce its development plan for the launch of NBTXR3 on the market.

It is with this first indication, advanced STS, that NBTXR3 could be CE marked as early as 2016, brought forward from the Company’s initial estimate of 2017. To achieve this, the product registration phase (pivotal) will begin in late 2014.

On 10 February 2014, the Independent Data Monitoring Committee (IDMC) met and gave a positive assessment of the recent pilot STS data which showed that NBTXR3 had a good safety profile, which is infrequent in oncology. Expert opinions, combined with encouraging signs of efficacy, have led to further product development in this indication.

The aim of NBTXR3 is to facilitate complete tumor resections and provide a significant clinical benefit to patients.

With the support of Bpifrance under the NICE project, Nanobiotix is pursuing the non-clinical evaluation phase of NBTXR3 with a view to initiating a clinical trial of NBTXR3 in patients suffering from liver cancer. In this population of patients, the aim of using NBTXR3 is to increase and prolong patients’ survival rates. The non-clinical evaluation phase is expected to be finalized in Q2 2014.

Nanobiotix also continues to progress the clinical development of NBTXR3 in elderly patients with head and neck cancers through 2014. The pilot trial aims to assess the patient’s tolerance to the product in the perspective of providing better control of the disease and an improved quality of life.

Laurent Levy, CEO of Nanobiotix said, “We are now in the final stages of development of our first product from the NanoXray pipeline: NBTXR3. Through its ability to enhance the effect of radiotherapy without increasing damage to the surrounding tissue, this product is designed to address a significant unmet medical need for advanced STS patients. We have progressed development faster than expected, which is good news for the patients who may benefit sooner from our breakthrough technology. This is a major milestone for the company, made possible through the work of our teams and our partners.”

In 2014, Nanobiotix will pursue its partnership policy for the development and market access of NBTXR3 outside Europe.

For its development in Asia, Nanobiotix signed its first licensing contract of up to US$57 million with the Taiwanese company, PharmaEngine, in August 2012, to cover the development and commercialization of NBTXR3 in the Asia-Pacific region. This program is expected to start in H2 2014 with two indications, advanced rectal cancer and advanced mouth cancer.

For NBTXR3’s development and commercialization in the United States, Nanobiotix is investigating the possibility of partnering the product in 2014 as announced during the IPO.

In Europe, the Company will focus on market access and the preparation for a commercial launch of NBTXR3.

Underlying these activities, Nanobiotix has developed numerous partnerships with hospitals, clinics and cancer treatment centers in France and internationally.

“The completion of this new step for NBTXR3 helps to de-risk the development and enables us to consider the applications of NanoXray products in STS and other cancer indications,” added Dr. Elsa Borghi, CMO of Nanobiotix. “For many oncology patients, tumor removal can have a significant impact on their treatment outcome. We are now entering a pivotal stage in NBTXR3’s development to establish whether we have an effective therapy for this unmet need, in STS and in other cancer indications.”


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 4,000+ scientific posters on ePosters
  • More than 5,300+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Nanobiotix Half Year Results for the Six Months Ended 30 June 2014
Significant operational and clinical progress made.
Tuesday, September 02, 2014
NANOBIOTIX honored at the INVESTOR AWARDS 2013 in the “Young Talent” category
NANOBIOTIX announced it has been awarded the “Young Talent” Award at the INVESTOR AWARDS 2013, referring to a newly listed company.
Friday, November 08, 2013
Nanobiotix Announces €2.8 Million Grant to Develop NBTXR3
Through ETPN, Nanobiotix is driving nanomedicine in Europe and is now involved in the first nanomedicine consortium in France with the launch of NICE project.
Friday, July 05, 2013
Nanobiotix Receives Approval from ANSM to Start New Clinical Trial with NBTXR3
Second indication for NanoXray product in Head and Neck cancer patients.
Thursday, June 13, 2013
Scientific News
Big Genetics in BC: The American Society for Human Genetics 2016 Meeting
Themes at this year's meeting ranged from the verification, validation, and sharing of data, to the translation of laboratory findings into actionable clinical results.
Personality Traits, Psychiatric Disorders Linked to Specific Genomic Locations
Researchers have unearthed genetic correlations between personality traits and psychiatric disorders.
Genetics Control Regenerative Properties Of Stem Cells
Researchers define how genetic factors control regenerative properties of blood-forming stem cells.
Diabetes Missing Link Discovered
Researchers from the University of Auckland have shown that beta catenin plays a vital role in the control of insulin release from the pancreas.
Study Reveals New Role for Hippo Pathway in Suppressing Cancer Immunity
Hippo pathway signaling regulates organ size by moderating cell growth, apoptosis and stem cell renewal, but dysregulation contributes to cancer development.
Gene-Editing Improves Vision in Blind Rats
Scientists developed a targeted gene-replacement technique that can modify genes in both dividing and non-dividing cells in living animals.
Gene Editing Yields Tomatoes That Ripen Weeks Earlier
Research team develop method to make tomato plants flower and ripen fruit two weeks faster than current growth rates.
Exploring the Genome of the River Blindness Parasite
Researchers have decoded the genome of the parasite that causes the skin and eye infection known as river blindness.
Gene Therapy Maintains Clotting Factor for Hemophilia Patients
Following a single gene therapy dose, the highest levels of an essential blood clotting factor IX were observed in hemophilia B patients.
Unexpected Role for Epigenetic Enzymes in Cancer
Researchers use epigenetics to identify the role of an enzyme family as regulators of genetic message interpretation in yeast.
Skyscraper Banner

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
4,000+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,300+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!