NANOBIOTIX Provides Update on Global Development of Lead Product NBTXR3
(Thomson Reuters ONE) -
Nanobiotix Provides Update on Global Development
of 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 NBTXR3
The 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 indication
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.
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 Phase II/III Recruiting Interim readout
(locally advanced) EU, Asia-Pac, 115 patients Spring 2017
South Africa randomized, 153
patients signed the
informed consent
Head and Neck Phase I/II Recruiting Complete data to be
cancer EU Safety and presented in H2 2017
(RTx alone in feasibility
elderly patients) established
Liver cancers Phase I/II Recruiting First data readout
(HCC & Mets) France on safety and
feasibility on first
patients treated:
before end of 2016
Prostate cancer Phase I/II Recruiting Interim readout on
USA safety and
feasibility
Rectum cancer Phase I/II Recruiting First data readout
Asia-pacific on safety and
region feasibility upon
completion of PI
portion
Head and Neck Phase I/II Recruiting First data readout
cancer (RTx plus Asia-pacific on safety and
Chemo) region feasibility upon
completion of PI
portion
NBTXR3 first market authorization filing
The 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-oncology
In 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 Gaubert
Head of Communication
and Public Affairs
+33 (0)1 40 26 07 55
contact(at)nanobiotix.com
------------------------ -----------------------------------------------------
Media relations
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Consultants Instinctif Partners Group
Marina Rosoff Melanie Toyne Sewell Kirsten Thomas / Chris
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marina(at)springbok.fr nanobiotix(at)instinctif.com +1 508-280-6592 /
+1 646-536-7023
Nanobiotix(at)theruthgroup.com
Disclaimer
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.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.
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: NANOBIOTIX via GlobeNewswire
Datum: 28.11.2016 - 19:59 Uhr
Sprache: Deutsch
News-ID 509511
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