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
USAGE |
INDICATION |
PHASE |
STATUS |
NEXT
STEP |
Single Agent |
Head and Neck
Cancer (Radiotherapy alone in elderly patients) |
Phase I/IIEU |
RecruitingSafety and
feasibility established |
Interim update on
expansion cohort - mid-2018 |
Liver Cancers (HCC
& Metastasis) |
Phase I/IIFrance |
Recruiting |
First set of trial data
(primary & Liver Mets) - January 2018 |
Soft Tissue Sarcoma
(locally advanced) |
Phase II/IIIEU,
Asia-Pacific, South Africa |
End of recruitment |
Presentation of results -
H1 2018 |
Rectum Cancer
|
Phase I/IIAsia-Pacific
region |
Recruiting
|
PharmaEngine calendar |
Prostate
Cancer |
Phase I/IIUS |
Recruiting |
2018 |
Other
Indications |
Preclinical |
|
2018 |
Combinations |
Head and Neck
Cancer (Radiotherapy + Chemotherapy) |
Phase
I/IIAsia-Pacific |
Recruiting |
PharmaEngine calendar |
Head and Neck &
Lung Cancers + checkpoint inhibitors |
Phase IUS |
IND application in
process |
IND approval - H1
2018 |
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
Nanobiotix |
Sarah GaubertDirector, Communications & Public
Affairs+33 (0)1 40 26 07 55sarah.gaubert@nanobiotix.com
/contact@nanobiotix.com |
Noël Kurdi Director, Investor
Relations +1 (646) 241-4400 noel.kurdi@nanobiotix.com /
investors@nanobiotix.com |
Media relations |
France -
Springbok ConsultantsMarina Rosoff+33 (0)6 71 58 00
34marina@springbok.fr |
|
United States -
RooneyPartners Marion Janic +1 (212)
223-4017mjanic@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.
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