NANOBIOTIX: NEW TRANSLATIONAL DATA
PRESENTED AT ASTRO, NCI AND SITC'S IMMUNOTHERAPY
WORKSHOP
- Translational data showing tumor immune activity and
positive Tumor Infiltrating Lymphocytes (TILs) in human and mouse
model
- Confirmation of the ability to transform "cold" tumors
into "hot" tumors and that NBTXR3 treatment may have an impact on
the tumor microenvironment
- Opening up of the potential for NBTXR3 to treat
metastases
Paris, France and Cambridge, Massachusetts
(USA), June 15, 2017 - NANOBIOTIX (Euronext: NANO - ISIN:
FR0011341205), a late clinical-stage nanomedicine company
pioneering new approaches to the treatment of cancer, today
presented new translational data at the "Immunotherapy workshop -
Incorporating Radiation Oncology into Immunotherapy" co-sponsored
by the American Society of Radiation Oncology (ASTRO), the National
Cancer Institute (NCI) and the Society for Immunotherapy of Cancer
(SITC), that takes place from June 15 to 16, 2017 in Bethesda,
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 suggests that NBTXR3
generates immunogenic cell death which could trigger a specific
immune response to attack the tumor.
Many tumors exhibit little or no response to
therapies targeting the immune system and are considered "cold".
The explanation for the lack of response in its simplest form, is a
lack of immunogenicity. The ability of NBTXR3 to generate
intratumoral immunogenic cell death (ICD) could be a key to
significantly increasing the number of patients who can benefit
from the help of their immune system to fight their cancer.
Today, Nanobiotix presented new translational
data from its immuno-oncology program.
"Hafnium oxide nanoparticle, a potent
radiation enhancer for in situ cancer vaccine" (June 15,
2017)J. Galon1, M. Laé2, Z. Papai3, P. Rochaix4, L.C. Mangel5,
F. Hermitte6, Z. Sapi7, M. Delannes4, T. Tornoczky5 , A.
Vincent-Salomon2, V. Servois2, H. Brisse2, S. Paris8, A. Pottier8,
and S. Bonvalot21INSERM, Paris, France, 2Institut Curie, Paris,
France, 3Magyar Honvedseg Egeszsegugyi Kozpont, Budapest, Hungary,
4Institut Universitaire du Cancer, Toulouse, France, 5Pecs
University, Pecs, Hungary, 6HalioDx, Marseille, France, 7Semmelweis
University, Budapest, Hungary, 8Nanobiotix, Paris, France.
- Human Soft Tissue Sarcoma (STS) patients data
In tumors of STS patients, a significant
increase of T cells (CD3+, CD8+) and a marked increase of dendritic
cell (CD103+) infiltrates in post- versus pre-treatment were
observed for NBTXR3 plus radiotherapy arm, while no differences
were seen in the use of radiotherapy alone. These findings
demonstrate the ability of NBTXR3 to transform cold tumors (as Soft
Tissue Sarcoma) in hot tumors.
Large hemorrhagic zones have been found in tumor
tissues treated with NBTXR3, whereas tumors treated with
radiotherapy alone did not show such patterns. This finding shows
that NBTXR3 could affect the tumor microenvironment and potentially
allow better infiltration of activated T Cells.
The upregulation of adaptive immunity gene
expression between pre- and post-treatment was pronounced for
NBTXR3 plus radiotherapy - 72 genes only up-regulated with the
NBTXR3 treatment, showing enrichment of cytokine activity and of
the T cell receptor signaling pathway.
A number of upregulated genes correspond to
existing or promising IO targets, enabling a potential combination
of NBTXR3 with therapeutic approaches, like products targeting PD1,
PDL1, CTLA4, etc. This data requires confirmation in additional
studies.
Asymmetrical volcano plot shows a trend toward
the upregulation of panimmune genes in post-treated tumors
of Soft Tissue Sarcoma patients. The two charts compare
the results of patients treated with radiotherapy alone (left),
with patients treated with radiotherapy plus NBTXR3
(right).
- Mice model (CT26) data
In mice, the abscopal effect (i.e. an effect
outside the scope of the localized treatment) was evaluated. A
tumor was implanted on each side of each mouse; one of the tumors
was treated with either NBTXR3 and radiotherapy, or radiotherapy
alone; while the other remained untreated. The treated tumors, both
those that received NBTXR3 and radiotherapy and those that received
radiotherapy alone, demonstrated volume shrinkage.
However, the study showed that only the use of
NBTXR3 with radiotherapy resulted in a control on the untreated
tumors (abscopal effect). No effect was observed in control groups
and groups treated with radiation therapy alone.
In this model, NBTXR3 plus radiotherapy induces
a noticeable increase of CD8+ and macrophages infiltrates in both
tumors (treated and untreated). At the same time, no effect was
observed in cases where radiotherapy was used alone, when compared
to control groups (that received no irradiation). This demonstrates
that NBTXR3 plus radiotherapy can induce a marked systemic
antitumor immune response on distant and untreated tumors where
radiotherapy alone couldn't.
- Conclusion
Taken together, these non-clinical and
preliminary clinical results confirm that NBTXR3 plus radiotherapy
could efficiently prime the 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.
NBTXR3 with radiotherapy could transform these tumors into an
effective in situ vaccine, opening up very promising perspectives
in the treatment of local cancer and metastases.
Tumor Immune Cell Infiltrates (TILs)
NBTXR3 competitive positioning in IO
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 widely
applied 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.
The new clinical data and previous pre-clinical
data indicate that NBTXR3 could play a key role in oncology and
could become a backbone in immuno-oncology.
***
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 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.
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 has filed in August 2016 for market approval (CE Marking)
in Europe for its lead product NBTXR3.
The Company started in 2016 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 Headquarter is based in Paris,
France. Affiliate in Cambridge, United States.
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 |
|
DisclaimerThis 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 update of the
reference document of Nanobiotix filed with the French Financial
Markets Authority (Autorité des Marchés Financiers) under number
D.16-0732-A01 on December 27, 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. 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.
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