Nanobiotix’s Partner, PharmaEngine, Has Launched a New NBTXR3 Clinical Trial in Head and Neck Cancers in Asia
October 21 2016 - 07:00AM
Business Wire
Seventh clinical trial with NBTXR3 in a new
population of patients with head and neck cancers treated with
radiotherapy plus chemotherapy
Regulatory News:
NANOBIOTIX (Paris:NANO) (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.”
-Ends-
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.
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.
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NanobiotixSarah Gaubert, +33 (0)1 40 26 07 55Head of
Communication and Public Affairscontact@nanobiotix.comorMedia
relationsFrance - SpringbokMarina Rosoff, +33 (0)6 11
58 00 34marina@springbok.frorEU Outside
France - Instinctif PartnersMelanie Toyne Sewell, +44
(0) 207 457 2020nanobiotix@instinctif.comorUnited States – The
Ruth GroupKirsten Thomas / Chris Hippolyte+1
508-280-6592 / +1 646-536-7023Nanobiotix@theruthgroup.com
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