NANOBIOTIX provides update on the global development of its lead product NBTXR3
(Thomson Reuters ONE) -
Nanobiotix provides update on the global development of its lead product NBTXR3
* Nanobiotix will give two immuno-oncology presentations at the Society for
Immunotherapy of Cancer (SITC) conference this month
* Tolerability, safety and first tumor response data in liver cancer will be
presented at the ASCO GI conference in January 2018
* IND application in process of being filed in the U.S. for a combination
trial with checkpoint inhibitors
Paris, France and Cambridge, Massachusetts, USA, November 9, 2017 -
NANOBIOTIX (Euronext: NANO - ISIN: FR0011341205), a late clinical-stage
nanomedicine company pioneering new approaches to the treatment of cancer, today
provides an update on the global development of its lead product, NBTXR3.
Nanobiotix's lead product, NBTXR3, has a universal physical mode of action which
is designed for the local destruction of tumors. In addition to the physical
destruction of cancer cells, recently published data suggests that NBTXR3
generates immunogenic cell death that could trigger a specific immune response
to attack tumors. In this regard, Nanobiotix is developing several programs in
Immuno-Oncology on top of its core developments.
The global development of NBTXR3 is progressing well, following the Company's
expectations.
Status of ongoing clinical trials
NBTXR3 INDICATION PHASE STATUS NEXT STEP
USAGE
Head and Neck Phase I/II Recruiting Interim update
Cancer EU Safety and on expansion
(Radiotherapy feasibility cohort - mid-
alone in elderly established 2018
patients)
Liver Cancers Phase I/II Recruiting First set of
(HCC & France trial data
Metastasis) (primary &
Liver Mets) -
January 2018
Single Agent Soft Tissue Phase II/III End of Presentation of
Sarcoma EU, Asia- recruitment results - H1
(locally Pacific, South 2018
advanced) Africa
Rectum Cancer Phase I/II Recruiting PharmaEngine
Asia-Pacific calendar
region
Prostate Cancer Phase I/II Recruiting 2018
US
Other Preclinical 2018
Indications
Head and Neck Phase I/II Recruiting PharmaEngine
Cancer Asia-Pacific calendar
(Radiotherapy +
Chemotherapy)
Combinations
Head and Neck & Phase I IND IND approval -
Lung Cancers + US application in H1 2018
checkpoint process
inhibitors
NBTXR3 in Head and Neck Cancer, Phase I/II trial, in elderly patients (Europe)
Prof. Christophe Le Tourneau, the trial's Principal Investigator, presented an
update during the Trends in Head and Neck Oncology conference (THNO) earlier
this month. This update included a median follow up of 14.2 months, confirming
the potential impact of NBTXR3 on the long-term response of the treatment.
Following the very positive results obtained, Nanobiotix filed a protocol
amendment of this study to include 44 additional patients - an expansion which
aims to demonstrate the efficacy of NBTXR3. Nanobiotix is also opening 12-15
additional sites in Europe to expand the development of this indication.
NBTXR3 Immuno-Oncology clinical and preclinical programs
The Society for Immunotherapy of Cancer (SITC) conference has invited Nanobiotix
to present an update of its Immuno-Oncology program on Soft Tissue Sarcoma (STS)
patient data on November 11, 2017. During this conference, the Company will also
provide preclinical Immuno-Oncological data on November 12, 2017.
NBTXR3 in Liver Cancers, Phase I/II trial (France)
Nanobiotix has been selected to present at the ASCO GI conference, the world's
leading gastrointestinal oncology symposium, on January 18-20, 2018. The Company
plans to present the safety and tolerability results and the first tumor
response of patients treated at the first dose levels, and detail the next steps
of the trial.
NBTXR3 in Combination with Checkpoint Inhibitors in Lung and Head and Neck
Cancer patients (U.S.) - Immuno-Oncology program
Nanobiotix plans to conduct its first clinical trial with NBTXR3 in combination
with immune checkpoint inhibitors in the U.S., with a multi-arm trial targeting
a sub-population of advanced lung, and head and neck cancer patients. The
medium-term objective is to transform non-responders into checkpoint inhibitor
responders while improving patient benefits. The trial aims to evaluate the
ability of NBTXR3 to generate an abscopal effect.
This trial also aims to expand the potential of NBTXR3, including using it to
treat recurrent or metastatic disease.
The trial would begin by combining NBTXR3 with any approved checkpoint
inhibitors in head and neck squamous cell carcinoma or non-small cell lung
cancer.
The IND application for this trial is ongoing.
NBTXR3 - CE Marking
Nanobiotix is working closely with the notified body in order to prepare for the
CE Marking. The process is progressing according to plan and the Company's
original time horizon remains unchanged.
***
About NANOBIOTIX: www.nanobiotix.com
Nanobiotix (Euronext: NANO / ISIN: FR0011341205) is a late clinical-stage
nanomedicine company pioneering novel approaches for the treatment of cancer.
The Company's first-in-class, proprietary technology, NanoXray, enhances
radiotherapy energy with a view to providing 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 filed in
August 2016 for market approval (CE Marking) in Europe for its lead product
NBTXR3.
In 2016 the Company started a new preclinical research program in Immuno-
oncology with its lead product NBTXR3, which could have the potential to bring a
new dimension to cancer immunotherapies.
Nanobiotix is listed on the regulated market of Euronext in Paris (ISIN:
FR0011341205, Euronext ticker: NANO, Bloomberg: NANO: FP). The Company's
Headquarters is based in Paris, France, with a U.S. affiliate in Cambridge, MA.
Contact
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Nanobiotix
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Sarah Gaubert Noël Kurdi
Director, Communications & Public Director, Investor Relations
Affairs +1 (646) 241-4400
+33 (0)1 40 26 07 55 noel.kurdi(at)nanobiotix.com /
sarah.gaubert(at)nanobiotix.com / investors(at)nanobiotix.com
contact(at)nanobiotix.com
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Media relations
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France - Springbok Consultants United States -
Marina Rosoff RooneyPartners
+33 (0)6 71 58 00 34 Marion Janic
marina(at)springbok.fr +1 (212) 223-4017
mjanic(at)rooneyco.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.17-
0470 on April 28, 2017 (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. 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.
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: 09.11.2017 - 20:14 Uhr
Sprache: Deutsch
News-ID 567586
Anzahl Zeichen: 11639
contact information:
Town:
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Kategorie:
Business News
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