Small but heading for the big time
Nanobiotix establishes promising
preclinical proof-of-concept in Immuno Oncology
PARIS and CAMBRIDGE, Mass., May 31, 2016 (GLOBE NEWSWIRE)
-- NANOBIOTIX (Euronext: NANO - ISIN: FR0011341205), a
late clinical-stage nanomedicine company pioneering novel
approaches for the local treatment of cancer, announces today that
the Company has established preliminary preclinical
proof-of-concept (POC) with the lead product NBTXR3 for its new
program in Immuno Oncology (IO).
- Delivering first promising data with its Immuno Oncology
preclinical program, showing the potential to turn the tumor itself
into a vaccine using NBTXR3
- Creating a potential new usage and new market for NBTXR3 in
parallel to its mainstream clinical development
- Providing new opportunities by combining NBTXR3 with other
Immuno Oncology drugs with a unique competitive advantage
Immuno-oncology works by boosting patients' immune systems to
recognise and attack tumours and therefore, kill the cancer. The
approach is very efficient for a limited number of patients whose
tumors have the ability to provoke an immune response i.e. they
have a natural and sufficient immunogenicity, and are referred to
as 'hot' tumors. However, in many patients, the tumours are 'cold'
and the therapeutic approach has little response.
To be able to expand the number of patients that can respond to
IO, thereby exploiting its full potential, immunogenicity needs to
be increased at the tumor level. Nanobiotix's approach to achieve
this is to trigger Immunogenic Cell Death (ICD) at the tumor level,
transforming "cold tumors" into "hot tumors".
Preliminary in vitro and in vivo preclinical data suggest that
Nanobiotix's radioenhancer NBTXR3 might be used, not only to
destroy tumors (as it is currently being clinically developed), but
also to enhance the power of radiotherapy to create intratumoral
vaccines for IO, and convert 'cold' tumours to 'hot'.
NBTXR3 current clinical development to destroy tumors and
provide better local control of cancer
NBTXR3 is a radio-enhancer, using a physical mode of action to
destroy cancer cells in any solid tumors, in combination with
radiotherapy.
Nanobiotix is running a global clinical development program with
its lead product NBTXR3, in six indications across Europe, the US
and the Asia-Pacific Region: a registration trial in soft tissue
sarcoma, and Phase I/II trials in liver cancers (HCC and liver
metastases), prostate cancer, head and neck cancer and rectal
cancer (in Asia by Nanobiotix's partner PharmaEngine).
New usage of NBTXR3 for in situ (intratumoral) vaccination
opening new potential prospects in Immuno Oncology: preliminary
preclinical proof of concept
NBTXR3 nanoparticles' activation by radiation enhances the
energy deposited where they are injected, improving cancer cell
death and the efficacy of radiotherapy. This technology is based on
physics and can potentially be applied across all radiotherapy
indications. All preclinical model (in vitro and in vivo) have
shown a systematic superiority of cell killing, when using NBTXR3
with radiotherapy, compared to radiotherapy alone.
In vitro POC: Immunogenic Cell Death
(ICD)
The ability to generate ICD can be seen through the generation
of Damage-Associated Molecular Pattern (DAMPs) such as HMGB1, ATP,
Calreticulin. HMGB1 among other DAMPs have also been shown to be
relevant as biomarkers that can be translated into the clinical
setting.
Release of such DAMPs have been tested in different human
resistant or sensitive cancer cell lines (including glioblastoma,
colorectal and pancreatic cancers).
NBTXR3 in combination with radiotherapy has shown superiority
versus radiation alone in the generation of DAMPs: HMGB1 (from 25%
up to 47% increase) and ATP (around 30%).
In vivo POC: vaccination assays on Immuno competent
mice
Classical vaccination assays have been performed to demonstrate
that in vitro generation of ICD could stimulate the immune response
and provide bases for long term vaccination. Vaccination experiment
have shown superiority in combining NBTXR3 with radiotherapy versus
radiotherapy alone.
CT26 cells (murine colorectal cancer cells) were irradiated in
the presence of NBTXR3 and without, and injected subcutaneously
(s.c.) into one flank of the mice (vaccination phase). One week
later, living CT26 cells were injected s.c. in the opposite flank
of the same animals (challenge phase). The host immune response
against these cells was evaluated by the apparition of at least one
tumor (vaccination and/or challenge site). The percentage of tumor
free mice (see figure below) with 6Gy+NBTXR3 is 66%, compared to
33% for 6Gy alone and 17% for the control group. This suggests a
better immune response against CT26 cells for animals vaccinated
with cells treated with NBTXR3 and irradiation, compared to
irradiation alone. These results strongly suggest that combination
of NBTXR3 with radiation therapy could significantly increase the
immune response against cancer cells compared to irradiation
alone.
Laurent Levy, Chief Executive Officer of Nanobiotix commented:
"Radiotherapy is a standard of care in oncology. Today it is also
being widely explored for its potential to transform 'cold' tumors
into 'hot' tumors, which could lead to expand the number of
patients eligible to Immuno Oncology across oncology.
"These promising preliminary proof-of-concept results show that
NBTXR3 may have the power to not only destroy cancer cells more
effectively than by radiotherapy alone, but also to enhance the
immunogenicity of the tumor. This new program could potentially
broaden the use of our product NBTXR3 beyond its current
development plan and, if successful, increase the effectiveness of
IO in more patients."
NBTXR3 could offer a unique competitive positioning in IO, and
potentially increase the number of cancer patients eligible for
treatment
More and more preclinical and clinical evidence are showing that
radiotherapy could play a key role in Immuno oncology especially in
combination. Compared to chemo or biologics, radiotherapy (RTx)
could be used in many more clinical situations across oncology.
Moreover, radiotherapy is the only approach that is well
established as a standard of care and having limited or no systemic
toxicity.
Increasing the ICD induced by radiotherapy at the tumor level
across oncology with a patented NBTXR3 product, could provide a
unique medical and competitive advantage to many IO drugs.
Nanobiotix core business remains focused on the development of
NBTXR3 to be use as a single agent in combination with
radiotherapy. This program is expected to deliver important
clinical data in several indications for the coming months and
years, with a first market approval in Europe anticipated for the
end of the year 2016.
Given this additional potential on this new field, Nanobiotix
will reinforce its R&D effort in Immuno Oncology. The company
could also further explore the potential synergies with current
advanced approaches in the field such as Immune checkpoint targeted
mabs or drugs, Adoptive T-cell therapy, Oncolytic viruses,
Vaccines, etc.
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, rectal cancer (PharmaEngine) and
liver cancers (HCC and liver metastases). 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.
Contact
Nanobiotix |
|
Sarah Gaubert Head of Communication and Public
Affairs +33 (0)1 40 26 07 55 contact@nanobiotix.com |
|
Media relations |
France -
NewCap Annie-Florence Loyer +33 (0)6 88 20 35 59
afloyer@newcap.fr |
|
Outside France -
Instinctif Partners Melanie Toyne Sewell +44 (0) 207
457 2020 nanobiotix@instinctif.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 registered by the
French Financial Markets Authority (Autorité des marchés
financiers) on January 12, 2016 under number R.16-001 (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.
Press release (PDF)
http://hugin.info/157012/R/2016642/748015.pdf
HUG#2016642
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