Nanobiotix presented new clinical and
pre-clinical data confirming NBTXR3's significant potential role in
Immuno-Oncology at SITC Annual Meeting
- NBTXR3 activated by radiotherapy induces a significant
adaptive immune pattern versus radiotherapy alone in patients with
soft tissue sarcoma
- Patients treated with NBTXR3 and radiotherapy show a
marked increase of PD1 and CD8 infiltration
- Preclinical data on different animal models confirm
broad potential of NBTXR3 as a primer of the immune
response
- Strong data to support the rational for the upcoming
clinical trial in combination with check point
inhibitors.
Paris,
France and Cambridge, Massachusetts, USA, November 13, 2017
- NANOBIOTIX (Euronext: NANO - ISIN: FR0011341205), a late
clinical-stage nanomedicine company pioneering new approaches to
the treatment of cancer, recently presented positive clinical and
preclinical data from the ongoing immuno-oncology programs. These
data were presented at the 32nd Annual Meeting of the Society for
Immunotherapy of Cancer (SITC), held from November 8 to 12, 2017 in
National Harbor, Maryland, USA.
Nanobiotix's lead product, NBTXR3, has a
universal physical mode of action which is designed for the local
destruction of tumors. In addition to the physical destruction of
cancer cells, recently published data suggested that NBTXR3
generates immunogenic cell death which could trigger a specific
immune response to attack tumors.
The new clinical data and pre-clinical data
indicate that NBTXR3 could play a key role in oncology and could
become a backbone of immuno-oncology.
The data Nanobiotix recently presented at SITC
from its immuno-oncology programs included:
"Antitumor immunity in patients with locally
soft tissue sarcoma treated with hafnium oxide nanoparticles and
radiation therapy"[1] -- P 412
In this study, tumors from the ongoing two-arm
Phase II/III clinical trial were examined both pre- and
post-treatment in patients with locally advanced soft tissue
sarcoma who had received either NBTXR3 with radiotherapy (more than
10 patients) or radiotherapy alone (more than 10 patients).
The results observed in the post-treatment
examination of patients who received both NBTXR3 and radiotherapy
showed a significant increase of CD8+ T cells and a marked increase
of CD3+, PD-1 and CD103+ immune cell infiltration. In
contrast, there was no difference observed between pre- and
post-treatment examination when patients received radiotherapy
alone.
Furthermore, a functional analysis of genes
up-regulated in NBTXR3 plus Radiotherapy arm showed an enrichment
of cytokines, immune checkpoints, T cell activation, and
dendritic/macrophages markers.
These promising data confirm that NBTXR3
induces a specific adaptive immune pattern and brings substantial
changes to the tumor immune profile in patients with soft tissue
sarcoma. As such, it may convert the tumor immunologically and be
effectively combined with immunotherapeutic agents across
oncology.
These data strengthen the relevance of using
NBTXR3 in combination with immune checkpoint inhibitors. In
September 2017, Nanobiotix announced the Company's plan to conduct
its first clinical trial with NBTXR3 in combination with immune
checkpoint inhibitors in the U.S., with a multi-arm trial targeting
a sub-population of advanced lung, and head and neck cancer
patients.
"Transforming immunologically 'cold' tumor
into 'hot' tumor with hafnium oxide nanoparticles and radiation
therapy"[2] -- P 413
These in vivo pre-clinical studies explored the
ability of NBTXR3 to bring substantial immune cell infiltrations in
colorectal cancer and breast cancer models, and convert
immunologically "cold" tumors into "hot" tumors.
In mice bearing CT26 tumors (murine colorectal
cancer cells), a marked increase of cytokine content and immune
cell infiltrates was observed with NBTXR3 and radiotherapy compared
to radiotherapy alone.
In mice inoculated with 4T1 cells (murine breast
cancer model) previously treated with NBTXR3 and radiotherapy, a
marked increase of CD8+ was observed in tumors when compared to
those in mice inoculated with 4T1 cells treated only with
radiotherapy.
Data generated from colorectal and breast
cancer tumor models suggest that NBTXR3 triggers immunogenic
conversion of the tumor microenvironment regardless of the
molecular characteristics of the tumor. These data confirm the
broad potential of NBTXR3 as a primer of the immune
response.
***
About NANOBIOTIX's immuno-oncology research
program
Many IO combination strategies focus on
'priming' the tumor, which is now becoming a prerequisite of
turning a "cold" tumor into a "hot" tumor. Compared to other
modalities that could be used for priming the tumor, NBTXR3 could
have a number of advantages: the physical and universal mode of
action that could be used widely across oncology, the one-time
local injection and good fit within existing medical practice
already used as a basis for cancer treatment, as well as a very
good chronic safety profile and well-established manufacturing
process.
After more than 18 months of development, the
Company presented preclinical proof of concept demonstrating that
NBTXR3 actively stimulates the host immune system to attack tumor
cells.
Recently, Nanobiotix presented new translational
data. Taken together, these non-clinical and preliminary clinical
results confirm that NBTXR3 plus radiotherapy could efficiently
prime an adaptive antitumor immune response, turning "cold" tumors
in "hot" tumors. Additionally, these results suggest that the
physically-induced response and subsequent immune activation
triggered by the NBTXR3 treatment could be generic.
Results suggests that NBTXR3 with radiotherapy
could transform tumors into an effective in situ vaccine, opening
up very promising perspectives in the treatment of local cancer and
metastases.
On top of the Company's core development
activities, these findings could open new collaborations for NBTXR3
through combinations with other immuno-oncology drugs.
In September 2017, Nanobiotix announced its
intention to start a new trial in the company's immuno-oncology
(IO) program. The trial is aimed at expanding the potential of
NBTXR3 to recurrent and metastatic disease.
About NANOBIOTIX:
www.nanobiotix.com
Nanobiotix (Euronext: NANO / ISIN: FR0011341205)
is a late clinical-stage nanomedicine company pioneering novel
approaches for the treatment of cancer. The Company's
first-in-class, proprietary technology, NanoXray, enhances
radiotherapy energy with a view to providing 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 filed in August 2016 for market approval (CE Marking) in
Europe for its lead product NBTXR3.
In 2016 the Company started 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's Headquarters is based in Paris,
France, with a U.S. affiliate in Cambridge, MA.
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 |
|
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.17-0470
on April 28, 2017 (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.
[1] Authors : J. Galon1, M. Laé2, J. Thariat3,
S. Carrere4, Z. Papai5, M. Delannes6, P. Rochaix6, L. Mangel7, F.
Hermitte8, Z. Sapi9, T. Tornoczky7, V. Servois2, I. Birtwisle
Peyrottes3, R. Tetreau4, M-C. Château4, S. Paris10, H. Brisse2, and
S. Bonvalot2. 1INSERM, Paris, France, 2Institut Curie, Paris,
France, 3Centre Antoine Lacassagne, Nice, France, 4Centre regional
de lutte contre le cancer, Paul Lamarque, Montpellier,
France,5Medical Centre, Hungarian Defences Forces, 6Institut
Universitaire du Cancer Toulouse - Oncopole, Toulouse, France,
7Pecs University, Pecs, Hungary, 8HalioDx, Marseille, France,
9Semmelweis University, Budapest, Hungary, 10Nanobiotix, Paris,
France.
[2] Authors : S. Paris, A. Darmon, P. Zhang, M.
Bergère and L. Levy
Nanobiotix (EU:NANO)
Historical Stock Chart
From Jun 2024 to Jul 2024
Nanobiotix (EU:NANO)
Historical Stock Chart
From Jul 2023 to Jul 2024