Nanobiotix Provides Update on Global
Developmentof Lead Product NBTXR3
Seven clinical trials across the
world
More than 2/3 of STS patients recruited
in the "act.in.sarc" Phase II/III trial
Phase I/II prostate cancer trial now
recruiting in the U.S.
Paris, France and Cambridge, Massachusetts,
USA, November 28, 2016 - NANOBIOTIX (Euronext: NANO - ISIN:
FR0011341205), a late clinical-stage nanomedicine company
pioneering novel approaches for the local treatment of cancer,
today provides an update on the global development of its lead
product, NBTXR3, across all indications.
NBTXR3 is a first-in-class radio-enhancer
nanoparticle designed for direct injection into cancerous tumors.
NBTXR3 has the potential to improve radiotherapy efficacy by
destroying locally advanced tumors more efficiently. It has been
engineered to increase the local absorption of the radiotherapy
dose and thereby increasing the efficacy of radiotherapy with the
benefit of not increasing toxicity or causing damage to surrounding
healthy tissues.
Elsa BORGHI, CMO of Nanobiotix said: "We made
significant progress this year with the global clinical development
of NBTXR3 across seven clinical trials and we are looking forward
to potentially obtain a CE mark in 2017. Our filing was based on
the scale and significance of the results already seen. The
clinical and regulatory progress sets the stage for 2017, as we are
getting closer to establishing NBTXR3 in combination with
radiotherapy as a new treatment modality for patients suffering
from solid cancers."
Global development of NBTXR3The Company
currently has seven ongoing clinical trials across the world.
Overall 15 countries with 54 clinical centers and more than 300
physicians are involved in Nanobiotix's clinical trials.
Clinical development of NBTXR3 by
indicationNBTXR3 is being evaluated in: soft tissue sarcoma
(STS), head and neck cancers, prostate cancer, and liver cancers
(primary and metastases). Additionally, head and neck cancer and
rectal cancer trials led by Nanobiotix's Taiwanese partner,
PharmaEngine, are underway in the Asia Pacific region.
Highlights of clinical news:
- 115 patients have been randomized and 153 have signed the
informed consent in the STS pivotal clinical trial. The target of
104 patients needed for the interim readout has been reached. A
total of 156 STS evaluable patients is expected in the
"act.in.sarc" Phase II/III trial (www.actinsarc.com).
- The Company expects to release the conclusion of the interim
analysis conducted by an independent committee of experts in the
coming months. This analysis will be performed four months after
the 104th patient has been randomized (time to complete treatment
plus readout).
- PharmaEngine has started a new clinical trial in Asia in
October 2016 for head and neck patient's population receiving
chemotherapy in combination with radiotherapy.
- A Phase I/II prostate cancer trial has
been initiated in the US and now recruiting at Ronald Reagan
UCLA Medical Center, Los Angeles and Thomas Jefferson University
Hospital, Philadelphia. Dana Farber Cancer Institute, Boston should
be joining the trial soon.
Status of ongoing clinical trials
INDICATION |
PHASE |
STATUS |
NEXT
STEPS |
Soft Tissue Sarcoma
(locally advanced) |
Phase II/IIIEU, Asia-Pac,
South Africa |
Recruiting 115 patients
randomized, 153 patients signed the informed consent |
Interim readoutSpring
2017 |
Head and Neck
cancer (RTx alone in elderly patients) |
Phase I/IIEU |
RecruitingSafety and
feasibility established |
Complete data to be
presented in H2 2017 |
Liver cancers (HCC
& Mets) |
Phase I/IIFrance |
Recruiting |
First data readout on
safety and feasibility on first patients treated: before end of
2016 |
Prostate
cancer |
Phase I/IIUSA |
Recruiting |
Interim readout on safety
and feasibility |
Rectum cancer
|
Phase I/IIAsia-pacific
region |
Recruiting |
First data readout on
safety and feasibility upon completion of PI portion |
Head and Neck
cancer (RTx plus Chemo) |
Phase I/IIAsia-pacific
region |
Recruiting |
First data readout on
safety and feasibility upon completion of PI portion |
NBTXR3
first market authorization filingThe company filed for
certification of NBTXR3 in August 2016 based on the current
level of clinical and scientific evidence. LNE/G-MED, the French
notified body, has given guidance that the review of results for a
potential CE mark is expected in 2017.
Expansion into immuno-oncologyIn
November, the Company presented preclinical data at the annual
meeting of the Society for Immunotherapy of Cancer (SITC),
demonstrating that NBTXR3 actively stimulates the host immune
system to attack tumor cells. Study results suggested NBTXR3's
potential to transform the tumor into an in situ vaccine.
On top of the Company's core development
activities, these findings could open new potential collaborations
for NBTXR3 through combinations with other immuno-oncology
drugs.
Latest publications
- Clinical Cancer Research - on NBTXR3 in Soft Tissue Sarcoma
Phase I/II Trial : "First human study testing a new concept of
radio enhancement using nanoparticles (NBTXR3) activated by
radiation therapy in patients with locally advanced soft tissue
sarcomas (STS)", published 6 October 2016. Sylvie Bonvalot, Cécile
Le Pechoux, Thierry Debaere, Guy Kantor, Xavier Buy, Eberhard
Stoeckle, Paul Sargos, Philippe Terrier, Jean-michel Coindre,
Nathalie Lassau, Rafik AIT SARKOUH, Mikaela Dimitriu, Elsa Borghi,
Laurent Levy, Eric Deutsch and Jean Charles Soria.
10.1158/1078-0432.CCR-16-1297
- Poster presented at SITC conference "Hafnium oxide
nanoparticles, a radiation enhancer for in situ cancer vaccine",
authored by Paris S., Pottier A., Levy L., and Lu B.
---
About NANOBIOTIX: www.nanobiotix.com
Nanobiotix (Euronext: NANO / ISIN: FR0011341205)
is a late clinical-stage nanomedicine company pioneering novel
approaches for the local treatment of cancer. The Company's
first-in-class, proprietary technology, NanoXray, enhances
radiotherapy energy with a view to provide a new, more efficient
treatment for cancer patients.
NanoXray products are compatible with current
radiotherapy treatments and are meant to treat potentially a wide
variety of solid tumors including soft tissue sarcoma, head and
neck cancers, liver cancers, prostate cancer, breast cancer,
glioblastoma, etc., via multiple routes of administration.
NBTXR3 is being evaluated in: soft tissue
sarcoma (STS), head and neck cancers, prostate cancer, and liver
cancers (primary and metastases). Additionally, head and neck
cancer and rectal cancer trials led by Nanobiotix's Taiwanese
partner, PharmaEngine, are underway in the Asia Pacific region. The
Company has filed in August 2016 for market approval (CE Marking)
in Europe for its lead product NBTXR3.
Nanobiotix is listed on the regulated market of
Euronext in Paris (ISIN: FR0011341205, Euronext ticker: NANO,
Bloomberg: NANO: FP). The Company Headquarter is based in Paris,
France. Affiliate in Cambridge, United States.
Contact
Nanobiotix |
|
|
Sarah GaubertHead of Communication and Public
Affairs+33 (0)1 40 26 07 55contact@nanobiotix.com |
|
|
Media relations |
France -
Springbok ConsultantsMarina Rosoff+33 (0)6 71 58 00
34marina@springbok.fr |
|
EU
Outside France - Instinctif PartnersMelanie Toyne
Sewell+44 (0) 207 457 2020nanobiotix@instinctif.com |
United States -
The Ruth Group Kirsten Thomas / Chris Hippolyte+1
508-280-6592 / +1 646-536-7023Nanobiotix@theruthgroup.com |
DisclaimerThis 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.16-0732
on July 22, 2016 (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.
Nanobiotix (EU:NANO)
Historical Stock Chart
From Jun 2024 to Jul 2024
Nanobiotix (EU:NANO)
Historical Stock Chart
From Jul 2023 to Jul 2024