Nanobiotix plans to conduct its first
clinical trial with NBTXR3 in combination with immune checkpoint
inhibitors in the U.S.
- Multi-arm trial targets sub-population of advanced lung, and
head and neck cancer patients
- Medium term objective is to transform non-responders into
checkpoint inhibitor responders while improving patient
benefits
- Trial aims to evaluate the ability of NBTXR3 to generate an
abscopal effect
- Expands the potential for NBTXR3, including recurrent or
metastatic disease
- Trial should start with combining NBTXR3 with any approved
checkpoint inhibitors in head and neck squamous cell carcinoma or
non-small cell lung cancer
Paris, France and Cambridge, Massachusetts,
USA, September 28, 2017 - NANOBIOTIX
NANOBIOTIX(Euronext: NANO - ISIN: FR0011341205), a late
clinical-stage nanomedicine company pioneering new approaches to
the treatment of cancer, announced today 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.
The trial would target recurrent head and neck,
and metastatic lung cancer patients. Studies indicate that the vast
majority of oncology patients do not respond to checkpoint
inhibitors.
Nanobiotix's plan for this U.S.-based trial is
to evaluate its lead product, NBTXR3, in combination with immune
checkpoint inhibitors, with the aim of unlocking their vast
potential to convert refractory patients into responders.
Elsa Borghi, Nanobiotix's Chief Medical Officer
commented: "The immunomodulatory effects of NBTXR3 have the
potential to transform non-responders into responders. This
approach could be practice-changing, as it addresses unmet medical
needs through directed tumor in situ vaccination."
For the past decade, there has been excitement
around immuno-oncology agents' capacity to boost the immune
system's response, priming it for an active attack against tumor
cells. The response to checkpoint inhibitors in so-called "hot"
tumors, infiltrated by T-cells and characterized by an inflammatory
profile, has been striking with long-lasting clinical benefits in
many cancer patients.
However, many tumors exhibit little or no
response to therapies targeting the immune system and are
considered "cold", due to a lack of immunogenicity.
According to published data, only 15 to 20% of
non-small-cell lung cancer patients (NSCLC), and 13 to 22% of head
and neck squamous cell carcinoma patients (NHSCC) respond to
immunotherapy treatments.
Moreover, treatment using checkpoint inhibitors
is generally not effective against all tumor types ("cold" tumors
devoid of T-cell saturation, PD-1/PDL-1 blockage cannot drive an
anti-cancer response).
The physical mode of action and subsequent cell
death generated by NBTXR3 induce a different immunogenicity
compared to radiotherapy and chemotherapy. This could be the key to
significantly increasing the number of cancer patients who can
benefit from immuno-oncology strategies.
As Nanobiotix reported earlier this year at ASCO
2017, NBTXR3 activated by radiotherapy was shown to induce a
specific adaptive immune pattern that could potentially convert a
non-responder into an immune-responsive patient receptive to
treatment with checkpoint inhibitors.
On top of NBTXR3's core developments as a single
agent across seven oncology indications, Nanobiotix's
Immuno-Oncology combination program opens the door to new
developments, potential new indications, and important value
creation opportunities.
***
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 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.
The new clinical data and previous pre-clinical
data indicate that NBTXR3 could play a key role in oncology and
could become a backbone of immuno-oncology.
On top of the Company's core development
activities, these findings could open new collaborations for NBTXR3
through combinations with other immuno-oncology drugs.
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.
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