THE UNIVERSITY OF TEXAS MD ANDERSON
CANCER CENTER AND NANOBIOTIX HAVE AN AGREEMENT TO RUN
IMMUNOTHERAPEUTIC PRE-CLINICAL RESEARCH IN LUNG CANCER COMBINING
NBTXR3 AND NIVOLUMAB
Paris, France and Cambridge, Massachusetts,
USA, April 10, 2018 - NANOBIOTIX (Euronext: NANO - ISIN:
FR0011341205), a late clinical-stage nanomedicine company
pioneering new approaches to the treatment of cancer, today
announced that it will cooperate with The University of Texas MD
Anderson Cancer Center, Houston TX, to work on NBTXR3, Nanobiotix's
lead product. NBTXR3 is a first-in-class product designed to
destroy, when activated by radiotherapy, tumors and metastasis
through physical cell death and to induce immunogenic cell death
leading to specific activation of the immune system.
This project with MD Anderson, one of the
world's leading oncological research centers, will provide an
unparalleled ability to develop pre-clinical data using NBTXR3
activated by radiotherapy plus anti-PD1 Nivolumab (murine version
of Opdivo(TM)).
Dr. Elsa Borghi, CMO, said: "The main objective
of this collaboration is to analyze the micro environment of the
tumors treated with NBTXR3 activated by radiotherapy, in order to
increase and optimize the immune response."
Dr. James Welsh, MD, Associate Professor,
Department of Radiation Oncology, will be the Principal
Investigator and lead the research program. The project between MD
Anderson and Nanobiotix will take place over the course of two
years and will evaluate the use of NBTXR3 activated by radiotherapy
plus anti-PD1 Nivolumab (murine version of Opdivo(TM)), provided by
Bristol-Myers Squibb (BMS) in lung cancer models (in vitro and in
vivo). Lung cancer is one of the most common cancer worldwide,
accounting for 1.69 million deaths annually (WHO 2015).
The joint program will focus on 3 aims, leading
to the maximization of NBTXR3 potential benefits in triggering an
immune response:
- Evaluate the abscopal response through the combination of
NBTXR3 plus an anti-PD1 antibody and radiation therapy in specific
and resistent murine lung cancer models, in order to measure
NBTXR3's potential to control metastatic disease.
- Evaluate if NBTXR3 can further improve T cell activation for
standard radiotherapy fractions compared to SBRT, notably by
determining the STING activation in vitro in cancer cells with and
without NBTXR3.
- Continue the characterization of the different mechanisms and
types of cell death induced by NBTXR3 activated by radiation.
The joint program will also further explore the
potential future use of NBTXR3 in immuno-oncology with checkpoint
inhibitors, as well as its potential to control metastatic
disease.
As announced in December 26, 2017, the Company
has received from the Food and Drug Administration the approval of
its Investigational New Drug (IND) application and should launch
its first clinical trial combining NBTXR3 with immune checkpoint
inhibitors in the U.S. in Q2 2018. This will be a multi-arm trial
targeting a sub-population of advanced lung cancer patients and
head and neck cancer patients.
NBTXR3 positioning in IOMany 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, a 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.
Published preclinical and clinical data indicate
that NBTXR3 could play a key role in oncology and could become a
backbone in immuno-oncology.
Nanobiotix's immuno-oncology combination program
opens the door to new developments, potential new indications, and
important value creation opportunities.
***
About NBTXR3
NBTXR3 is a first-in-class product designed to
destroy, when activated by radiotherapy, tumors and metastasis
through physical cell death and to immunogenic cell death leading
to specific activation of the immune system.
NBTXR3 has a high degree of biocompatibility,
requires one single administration before the whole radiotherapy
treatment and has the ability to fit into current worldwide
standards of radiation care.
NBTXR3 is being evaluated in head and neck
cancer (locally advanced squamous cell carcinoma of the oral cavity
or oropharynx), and the trial targets frail and elderly patients
who have advanced cancer with very limited therapeutic options. The
Phase I/II trial has already delivered very promising results
regarding the local control of the tumors and a potential
metastatic control through in situ vaccination.
Nanobiotix is running an Immuno-Oncology program
with NBTXR3 that includes several studies. In the U.S., the Company
received the FDA's approval to launch a clinical study of NBTXR3
activated by radiotherapy in combination with anti-PD1 antibodies
in lung, and head and neck cancer patients (head and neck squamous
cell carcinoma and non-small cell lung cancer). This trial aims to
expand the potential of NBTXR3, including using it to treat
recurrent or metastatic disease.
The first market authorization process (CE
Marking) is ongoing in Europe in the soft tissue sarcoma
indication.
The other ongoing studies are treating patients
with liver cancers (hepatocellular carcinoma and liver metastasis),
locally advanced or unresectable rectal cancer in combination with
chemotherapy, head and neck cancer in combination with concurrent
chemotherapy, and prostate adenocarcinoma.
About NANOBIOTIX:
www.nanobiotix.com
Incorporated in 2003, Nanobiotix is a leading,
late clinical-stage nanomedicine company pioneering new approches
to significantly change patient outcomes by bringing nanophysics to
the heart of the cell.
The Nanobiotix philosophy is one rooted in
designing pioneer physical based approaches to bring highly
effective and generalized solutions to address high unmet medical
needs and challenges.
The Company's first-in-class, proprietary lead
technology, NanoXray, aims to expand radiotherapy benefits for
millions of cancer patients. Furthermore, the Company's
Immuno-Oncology program has the potential to bring a new dimension
to cancer immunotherapies.
Nanobiotix is listed on the regulated market of
Euronext in Paris (Euronext: NANO / ISIN: FR0011341205; Bloomberg:
NANO: FP). The Company's Headquarters are based in Paris, France,
with a U.S. affiliate in Cambridge, MA, and european affiliates in
Spain and Germany.
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 as well as in its 2017 annual financial report
filed with the French Financial Markets Authority on March 29, 2018
(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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