CE
Mark filing based on current level of scientific and clinical
evidence
Phase II/III clinical trial in Soft
Tissue Sarcoma progressing well towards interim data readout with
almost 2/3 of the patients randomized
NANOBIOTIX (Euronext: NANO - ISIN: FR0011341205), a late
clinical-stage nanomedicine company pioneering novel approaches for
the local treatment of cancer, has filed for market approval (CE
Marking) in Europe for its lead product, a first-in-class
radio-enhancer, NBTXR3.
The CE Marking submission package is in
particular based on current level of evidence generated in the
Act.In.Sarc registration trial for treatment of locally-advanced
soft tissue sarcoma (STS) and other NBTXR3 clinical trials. The
submission has been made in parallel with the continuation of the
Act.In.Sarc study and the wider clinical development of NBTXR3 in
different cancer indications.
The company filed for CE mark on August 23, and
received the confirmation from Gmed (the french notified body),
that the evaluation will start this month. The latest guidance
given by the notified body for review up to potential CE marking is
at least 9 months.
Laurent Levy, CEO of Nanobiotix, commented,
"This first market approval of NBTXR3 in Europe, is a major step
for Nanobiotix, the fruit of more than 10 years of research and
development. Recruitment has been a little slower than expected in
STS clinical trial but overall we are progressing well in our
global plan. With this filing we are closer to helping patients
every day in hospitals."
Interim analysis readout of the
Act.In.Sarc study The Act.In.Sarc study is a global,
randomized Phase II/III multi-center pivotal trial evaluating
NBTXR3 in combination with radiotherapy before surgery in
comparison to the current standard of care, radiotherapy alone,
prior to surgery. 156 patients are expected to be included in the
study. To date, 116 patients have been recruited and 92 patients
randomized across 39 sites in 13 countries.
Nanobiotix plans to release the conclusion of
the interim analysis conducted by an independent committee of
experts in the coming months. The independent committee of experts
will review (i) the data related to the primary endpoint (Complete
Pathological Response Rate), ensure (ii) the safety of all patients
enrolled in the study, (iii) the quality of the data collected, and
(iv) the continued scientific validity of the study design once two
third of the patients (104 patients) have been treated. This
analysis will be performed four months after the 104th patient has
been randomized (time to complete treatment plus readout).
The Company expects to complete patient
enrollment of the Act.In.Sarc study in the 2nd quarter 2017.
About NBTXR3 in Soft Tissue Sarcoma
(STS)
STS are cancers arising in different types of
tissues such as fat cells, muscles, joint structures and small
vessels, etc. In resectable cases, surgery is the only potentially
curative treatment and constitutes the basis to achieve prolonged
survival. Patients with high risk STS have few therapeutic
options.
A considerable proportion of patients present
with locally advanced primary or relapsed tumors cannot be resected
with "clean margins". These patients with big tumors are threatened
with amputation for complete tumor removal. Progress of surgical
techniques and the use of pre-operative radiotherapy have improved
the disease outcome. However local and distant failures are
frequently observed.
There is strong evidence in scientific
literature that supports the importance of local control of tumor
in patients with locally advanced STS. Indeed, achieving local
control, cellular destruction and good surgery in these patients
presenting with locally advanced disease are determinant factors to
improve disease free survival and overall survival. Similar outcome
is observed for other cancers.
Innovative treatments aimed at optimizing cancer
cell killing and the surgical feasibility are needed.
NBTXR3, is a first-in-class nanoparticle
radio-enhancer designed for direct injection into cancerous tumors
and is engineered to increase the dose and efficacy of radiotherapy
without increasing toxicity or causing damage to surrounding
healthy tissues. NBTXR3 has the potential to improve radiotherapy
efficacy by destroying locally advanced tumors more efficiently,
improving the chance of full tumor resection.
Treatment with NBTXR3 nanoparticles and
radiotherapy in locally advanced STS aims to destroy tumors more
efficiently, to facilitate surgery and enable complete malignant
tissue extraction during surgery.
NBTXR3 is a radioenhancer. The injected
nanoparticles penetrate tumor cells and when exposed to
radiotherapy make feasible the deposition of a high energy dose
within the cancer cell, increasing tumor shrinkage, cell killing
and thus improving resectability of the tumor with wide margins and
disease outcomes.
For more information, please visit
http://www.actinsarc.com/
About the Phase II/III registration Trial of
NBTXR3 in STS
The randomized trial will measure the antitumor
activity of NBTXR3 (administered by intratumoral injection) and
radiotherapy compared with radiotherapy alone. Patients in both
treatment arms (78 in each arm) will have a regular protocol which
means five weeks of radiotherapy, followed by surgical resection of
the tumor.
Primary Outcome Measures:
- Pathological Complete Response Rate (pCRR)
Secondary Outcome Measures:
- Incidence of early and late TEAE, post-TEAE, SAE and laboratory
abnormalities (NCI CTCAE V4.0)
- Objective Response Rate (ORR) by Imaging (MRI) according to
RECIST 1.1
- Tumor volume changes (theoretical tumor volume estimated as:
Lenght x Width x Depth
- Resection Margins (R0, R1, R2)
- Limb amputation rate
For more information: https://clinicaltrials.gov/ and
http://www.actinsarc.com/ About NANOBIOTIX:
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, rectal cancer
(PharmaEngine) and liver cancers (HCC and liver metastases). 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.
For more information, please visit
www.nanobiotix.com
Contact
Nanobiotix |
|
|
Sarah Gaubert Head of Communication and Public
Affairs +33 (0)1 40 26 07 55 contact@nanobiotix.com |
|
|
Media relations |
France -
NewCap Annie-Florence Loyer +33 (0)6 88 20 35 59
afloyer@newcap.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.
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.
Press release (PDF)
http://hugin.info/157012/R/2042002/762090.pdf
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