NANOBIOTIX : Nanobiotix expands its clinical development in Head and Neck cancer and Immuno-Oncology ; new clinical data to b...
April 04 2017 - 2:37AM
NANOBIOTIX EXPANDS ITS CLINICAL
DEVELOPMENT IN HEAD AND NECK CANCER AND
IMMUNO-ONCOLOGYNEW CLINICAL DATA TO BE PRESENTED
AT ASCO
Paris, France and Cambridge, Massachusetts,
April 4, 2017 - NANOBIOTIX (Euronext: NANO - ISIN:
FR0011341205), a late clinical-stage nanomedicine company
pioneering new approaches to the treatment of cancer, today
announced the expansion and acceleration of its clinical
development activities. These include:
- Acceleration of the head and neck cancer program. Phase I/II
data will be presented at ASCO in June
- Expansion of Nanobiotix's Immuno-Oncology program into patients
focused on the objective of turning cold tumors into hot tumors.
Nanobiotix will present the first clinical data from this program
mid year
NBTXR3: New programs and upcoming data
Presentation of the Phase I/II data of
Nanobiotix's European head and neck trial with NBTXR3 at the
American Society of Clinical Oncology (ASCO) Annual Meeting in
June. Nanobiotix is preparing the next clinical trials of the
head and neck cancer program. Based on the value of the data to be
presented in June, the Company will determine the fastest pathway
to the U.S. and European markets.
Presentation of the first clinical data from
Nanobiotix's new clinical program in Immuno-Oncology mid year.
Based on the preclinical proof of concept presented in November
2016 at the Society for Immunotherapy of Cancer (SITC), Nanobiotix
initiated an exploratory clinical biomarkers study in soft tissue
sarcoma patients (data from Nanobiotix's phase II/III trial in soft
tissues sarcoma). This trial investigates whether NBTXR3 could play
a role in Immuno-Oncology by turning cold tumors into hot tumors
(compared with radiotherapy alone).
Ongoing activities
Continuation of the Phase II/III trial in
soft tissue sarcoma with NBTXR3, recommended by an Independent
Data Monitoring Committee (IDMC), which evaluated the safety and
efficacy data of two thirds of the patients in the "Act.in.Sarc"
study. As planned and communicated, the completion of the patient
recruitment process for this trial is expected by the end of Q2
2017, with data, except for long-term follow-up, expected by the
end of 2017.
Nanobiotix will continue to develop NBTXR3 in
other indications: These include prostate cancer (Phase I/II),
liver cancers (Hepatocellular Phase I/II and liver cancer
metastases Phase I/II), rectum cancer (Phase I/II - by
PharmaEngine) and head and neck cancers in patients receiving
chemotherapy (Phase I/II - by PharmaEngine). In H2 2017, the
prostate cancer indication should deliver preliminary safety and
feasibility data. Additionally, before the end of 2017, Nanobiotix
aims to complete patient recruitment for the Phase I part in liver
cancers, and may proceed to select the patient population for the
dose-expansion part of the trial (Phase II).
In parallel, Nanobiotix is accelerating its
market preparations for NBTXR3's launch on the European market.
The first approval (CE marking) in Europe is expected in H2
2017. ***
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.
The Company started in 2016 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 Headquarter is based in Paris,
France. Affiliate in Cambridge, United States.
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 |
|
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 update of the
reference document of Nanobiotix filed with the French Financial
Markets Authority (Autorité des Marchés Financiers) under number
D.16-0732-A01 on December 27, 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. 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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