NANOBIOTIX ANNOUNCES FIRST
POSITIVE HUMAN DATA SHOWING THAT NBTXR3 COULD BECOME A BACKBONE IN
IMMUNO-ONCOLOGY
- Biomarker two-arm study in 26 Soft Tissue Sarcoma
patients
- Data shows a specific, adaptive immune pattern
triggered by NBTXR3 treatment
- Potential synergies with Immuno-oncology drugs
including checkpoint inhibitors
Paris, France and Cambridge, Massachusetts,
(USA) May 18, 2017 - NANOBIOTIX (Euronext: NANO - ISIN:
FR0011341205), a late clinical-stage nanomedicine company
pioneering new approaches to the treatment of cancer, today
announced its first set of clinical data from its immuno-oncology
(IO) program, showing the potential ability of NBTXR3 to transform
"cold" tumors into "hot" tumors.
Laurent Levy, CEO of Nanobiotix said, "Being
able to transform cold tumors into hot tumors is one of the most
challenging and promising topics in oncology. This preliminary
clinical data indicates that NBTXR3 could play a key role in
unlocking this potential. Given NBTXR3's universal type mode of
action and good safety profile, NBTXR3 could change the treatment
landscape in numerous solid tumor cancers."
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 increase the number of patients who can
engage their immune system to fight their cancer.
To undertake this research, Nanobiotix used the
available patient samples from its more advanced indication of soft
tissue sarcoma -- a typical "cold" tumor. These findings
demontrated that NBTXR3 plus radiotherapy induces a specific
adaptive immune pattern, which could potentially contribute to
converting a "cold" tumor into a "hot" tumor. In this study,
radiotherapy alone did not show any impact on triggering adaptive
immune response.
Key Results
Specific adaptive immune pattern induced by NBTXR3 when
exposed to radiation therapy in Soft Tissue Sarcoma (STS)
patients (#e14615)Jérôme Galon, Marick Laé,
Zsuzsanna Papai, Philippe Rochaix, Laszlo Csaba Mangel,
Bernhard Mlecnik, Fabienne Hermitte, Zoltan Sapi, Martine Delannes,
Tamas Tornoczky, Anne Vincent-Salomon, Sylvie Bonvalot;
INSERM, Paris, France; Institut Curie, Paris, France; Magyar
Honvedseg Egeszsegugyi Kozpont, Budapest, Hungary; Institut
Universitaire du Cancer Toulouse Oncopole, Toulouse, France; Pecs
University, Pecs, Hungary; HalioDX, Marseille, France; Semmelweis
University, Budapest, Hungary.
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 (14
patients) or radiotherapy alone (12 patients).
The results observed in the post-treatment
examination of patients who received both NBTXR3 and radiotherapy,
showed a significant increase of immune cell infiltration (CD3+,
CD8+). In contrast, there were no differences observed between pre-
and post-treatment examination where patients received radiotherapy
alone.Similarly, patients who received NBTXR3 plus radiotherapy
were found to have an increased immunoscore post-treatment,
compared to those who received radiotherapy alone.
The upregulation of pan-immune gene expression
and specifically, the expression of adaptive immunity genes between
pre- and post-treatment, was pronounced in the post-treatment
results of patients who received NBTXR3 plus radiotherapy compared
to those who received radiotherapy alone.
Furthermore, a functional analysis of
upregulated genes in NBTXR3 plus radiotherapy showed a specific
enrichment of cytokine activity (IL7, IFNA, IL16, IL11, IFNG),
adaptive immunity (RAG1, GZMA, TAP1, TAP2, TBX21, STAT4, IFNG, LCK,
LTK, CD37, CD22) and T-cell receptor signaling pathway (CD28,
CTLA4, CD274, BTLA, TIGIT, CD40LG, CD5, CD3E, ZAP70).
The initial data suggests NBTXR3's potential as
an IO agent that could, on its own, trigger a specific immune
response against the tumor. A number of upregulated genes
correspond to existing or promising IO targets, enabling potential
combination of NBTXR3 with therapeutic approaches, like products
targeting PD1, PDL1, CTLA4, etc. This data requires confirmation in
additional studies.
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 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.
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 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 completedPhase 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
alonePhase 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.*
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 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.
Nanobiotix (EU:NANO)
Historical Stock Chart
From May 2024 to Jun 2024
Nanobiotix (EU:NANO)
Historical Stock Chart
From Jun 2023 to Jun 2024