NANOBIOTIX (Euronext: NANO - ISIN: FR0011341205),
a late clinical-stage nanomedicine company pioneering novel
approaches for the local treatment of cancer, today announces
preclinical data demonstrating that its leading radioenhancer
nanoparticle, NBTXR3, actively stimulates the host immune system to
attack tumor cells. These data from the ongoing NBTXR3
immuno-oncology preclinical program were presented at one of the
leading global immuno-oncology conferences, the 31st Annual Meeting
of the Society for Immunotherapy of Cancer (SITC), being held
November 9-13, 2016 in National Harbor, Maryland, USA (Paris S.,
Pottier A., Levy L., and Lu B. Hafnium oxide nanoparticles, a
radiation enhancer for in situ cancer vaccine).
Laurent Levy, CEO of Nanobiotix, commented:
"These exciting data show that NBTXR3 could be a potential game
changer in Immuno-oncology combination landscape. This raises the
possibility of synergies between NBTXR3, radiotherapy and
immunotherapies. On the top of existing core developments of our
product as a single agent, this is opening new doors for industrial
collaborations."
Data presented showing the potential of
NBTXR3 in Immuno-Oncology
During the presentation, Nanobiotix scientists
and Dr. Bo Lu, MD, Director of the Molecular Radiation Biology in
the Department of Radiation Oncology at the Thomas Jefferson
University Hospital in Philadelphia, presented study results which
demonstrate that radiotherapy with NBTXR3 elicits a marked
enhancement of Immunogenic Cell Death (ICD) compared to
radiotherapy alone across different cancer cell lines, in
radioresistant or radiosensitive models.
In a second experiment, the phenomenon known as
the abscopal effect was evaluated (i.e. an effect outside the scope
of the localized treatment). Two tumors were implanted on both
sides of mice, and subsequently only one tumor was treated with
NBTXR3-radiation therapy. As a result, both tumors demonstrated
volume shrinkage. Specifically, the study showed that use of NBTXR3
in combination with radiotherapy resulted in a control on the
untreated tumor and a statistically significant increase of overall
survival. No abscopal effect was observed in control groups and
group treated with radiation therapy alone.
A third experiment has demonstrated that NBTXR3
combined with radiotherapy could be used to create a vaccine ex
vivo with a higher rate of long term vaccination success when
compared to radiotherapy alone.
Elsa Borghi, CMO of Nanobiotix commented:
"Although immunotherapies hold great promise in treating cancer,
one of the main barriers is that most of tumors do not provoke an
immune response, which renders immunotherapy ineffective in many
patients. The findings from this research indicate that NBTXR3
could have the potential to transform a tumor into an in situ
vaccine. It could convert an immunologically 'cold' tumor, which
does not provoke an immune response, to a 'hot' tumor, which
induces an immune response and therefore provokes a host immune
response to attack tumor cells."
NBTXR3 competitive positioning in
Immuno-Oncology
Radiotherapy is an established standard of care
in many solid tumor types (approximately 60% of all cancer patients
receive radiotherapy). Compared to other products used for priming
of the tumor, currently in development for Immuno-Oncology, NBTXR3
could have a number of advantages: a physical and universal mode of
action that could be used widely across oncology, one time local
injection, a good fit within existing medical practice already used
a base for cancer treatment, limited or no systemic toxicity, and a
well-established manufacturing process.
Radiotherapy is often given within the first
lines of cancer treatment, compare to most current positioning of
immuno-oncology development in a later stage treatment. A
successful approach using NBTXR3 in immuno-oncology could make it a
key player by offering treatment options in earlier stages of the
disease.
Taken together, these data indicate that
radiotherapy in combination with NBTXR3 could play a key role in
immuno- oncology and could be used in synergy with several
immuno-oncology approaches to increase patient responses across
many different types of cancer.
NBTXR3 current clinical development as a
single agent
Outside immuno-oncology field and as a single
agent, NBTXR3 is in late stage clinical development, for its
capability to enhance the dose of radiotherapy within the tumor and
more efficiently destroy cancer cells. Worldwide clinical
development is currently covering seven patient populations and a
first market approval has been filed in EU in August 2016.
---About
NBTXR3
Nanobiotix's lead product, NBTXR3, is a
first-in-class radio-enhancer nanoparticle designed for direct
injection into cancerous tumors. It has been engineered to increase
the dose and efficacy of radiotherapy without increasing toxicity
or causing damage to surrounding healthy tissues. NBTXR3 is
currently in late-stage clinical development as a single agent.
Worldwide clinical development of NBTXR3 now includes trials
across 7 patient populations:
- Soft Tissue Sarcoma (STS)
Phase
I/II trial
completed Phase
II/III "Act.in.Sarc." global trial (including EU, South Africa and
Asia-Pacific region)
Phase
I/II trial in France and Spain; NBTXR3 + Radiotherapy
alone Phase
I/II trial by PharmaEngine in Asia-Pacific; NBTXR3 + Radiotherapy
& Chemotherapy
Phase
I/II trial in the U.S
Phase
I/II Hepatocellular Cancer trial in France
Phase
I/II Liver Metastases trial in France
Phase
I/II trial by PharmaEngine in Asia-Pacific
First
market approval has been filed in the EU and could be obtained in
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.
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.
For more information, please visit
www.nanobiotix.com
Contact
Nanobiotix |
|
|
Sarah GaubertHead of Communication and
Public Affairs+33 (0)1 40 26 07 55contact@nanobiotix.com
|
|
|
Media relations |
France -
Springbok ConsultantsMarina
Rosoff+33 (0)6 71 58 00 34marina@springbok.fr |
|
EU
Outside France - Instinctif
PartnersMelanie Toyne Sewell+44 (0) 207
457 2020nanobiotix@instinctif.com |
United States -
The Ruth Group Kirsten Thomas / Chris
Hippolyte+1 508-280-6592 / +1
646-536-7023Nanobiotix@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.
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