Nanobiotix's partner, PharmaEngine, has launched a new NBTXR3 clinical trial in head and neck cancers in Asia
October 20 2016 - 3:51PM
NANOBIOTIX (Euronext: NANO - ISIN: FR0011341205), a late
clinical-stage nanomedicine company pioneering novel approaches for
the local treatment of cancer, today announced that its
Asia-Pacific partner, PharmaEngine, has dosed its first patient in
a new Phase I/II trial in patients with head and neck cancers
patient receiving radiotherapy plus chemotherapy, this October. The
trial is evaluating the optimal dose, safety and preliminary
efficacy of Nanobiotix's lead product.
PharmaEngine has broadened its development plan
for NBTXR3 by launching this new trial in Asia targeting a new and
larger head and neck cancer patient population. This follows the
successful results from the European Phase I/II trial in patients
with head and neck cancers presented in July 2016 by Nanobiotix
demonstrating promising signs of tumor volume response and
excellent signs of safety.
NBTXR3 is now addressing a wide range of head
and neck cancers patients. The study in Asia by PharmaEngine
addresses patients receiving chemotherapy (cisplatin) plus
radiotherapy whereas the study in Europe by Nanobiotix covers
patients which are not eligible for chemotherapy plus radiotherapy
and only receive radiotherapy.
Head and neck cancers include cancers of the
oral cavity, tongue and oropharynx. These cancers are a major
concern for public health, with a high worldwide prevalence,
particularly in Asia, where the patient population is
expanding.
This joint approach by Nanobiotix and
PharmaEngine supports the preparation of a development plan for
head and neck cancers registration studies with NBTXR3 potentially
in Europe, in the US and in Asia. Nanobiotix will provide this next
year.
Laurent Levy, CEO of Nanobiotix commented: "This
seventh trial opens significant potential market opportunities for
NBTRX3 by broadening the potential treatable population of head and
neck cancer patients for whom NBTXR3 may significantly improve
quality of life."
About the PharmaEngine Head and Neck Phase
I/II Trial in Asia
This new trial is an open-label, single arm,
non-randomized study for patients with head and neck cancers. The
primary objectives of the study are to determine the optimal dose,
safety and preliminary efficacy of NBTXR3 through intra-tumor
injection in combination with concurrent chemoradiotherapy (CCRT).
The first patient was injected with NBTXR3 in October 2016 and the
maximum number of patients that will be enrolled in the study is
42.
About Nanobiotix and PharmaEngine
Partnership
PharmaEngine has a licensing agreement with
Nanobiotix for the development and commercialization of
Nanobiotix's lead product, NBTXR3, in Asia-Pacific. As part of this
agreement, Nanobiotix has already received upfront payments and
milestone payments.
The Company is eligible to receive further
development and commercialization milestone payments. Collectively,
these payments may amount to a total of US$56 million plus tiered,
up to double-digit royalties on all net product sales in the
Asian-Pacific region.
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.
Nanobiotix's lead product NBTXR3, based on
NanoXray, is currently under clinical development for soft tissue
sarcoma, head and neck cancer, prostate cancer, and liver cancers
(HCC and liver metastases) as well as head and neck and rectal
cancers under trial by PharmaEngine. The Company has filed in
August 2016 for market approval (CE Marking) in Europe for its lead
product NBTXR3. The Company has partnered with PharmaEngine
for clinical development and commercialization of NBTXR3 in
Asia.
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@nanobiotix.com |
|
|
Media relations |
France -
Springbok Marina Rosoff +33 (0)6 11 58 00 34
marina@springbok.fr |
|
EU
Outside France - Instinctif Partners Melanie Toyne
Sewell +44 (0) 207 457 2020 nanobiotix@instinctif.com |
United States -
The Ruth Group Kirsten Thomas / Chris Hippolyte +1
508-280-6592 / +1 646-536-7023 Nanobiotix@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.
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