FDA APPROVES NANOBIOTIX'S FIRST
IMMUNO-ONCOLOGY TRIAL:A PHASE I/II STUDY OF NBTXR3 ACTIVATED
BY RADIATION THERAPY (SABR) FOR PATIENTS WITH NON-SMALL CELL
LUNG CANCER OR HEAD AND NECK SQUAMOUS CELL CARCINOMA CANCER
TREATED WITH AN ANTI-PD1 ANTIBODY (NIVOLUMAB OR
PEMBROLIZUMAB)
- First Nanobiotix immuno-oncology trial will be conducted in
the U.S.
- Multi-arm trial targets sub-population of advanced and
metastatic lung (NSCLC), and head and neck cancer patients
(HNSCC).
- Evaluation of NBTXR3's potential to turn anti-PD1 inhibitor
(nivolumab or pembrolizumad) non-responders at 12 weeks into
responders
- Trial will also include Head & Neck (HNSCC) cancer
patients that are anti-PD1 inhibitor naïve
- Expands the potential for NBTXR3 to help locoregionally
recurrent or metastatic disease patients through reirradiation or
treatment in a single lung or liver metastase
Paris,
France and Cambridge, Massachusetts, USA, December 26, 2017
- NANOBIOTIX NANOBIOTIX(Euronext: NANO - ISIN: FR0011341205), a
late clinical-stage nanomedicine company pioneering new approaches
to the treatment of cancer, today announced the U.S. Food and Drug
Administration (FDA) has approved its Investigational New Drug
(IND) Application for NBTXR3, a first-in-class nanoparticle
designed for direct injection into cancerous tumors, activated by
stereotactic ablative radiotherapy (SABR) and administered in
combination with an anti-PD1 antibody (nivolumab or
pembrolizumab).
Laurent Levy, CEO of Nanobiotix, stated: "The
FDA's approval of Nanobiotix's IND application for this trial is a
major milestone for our Company.We're ready and excited to launch
our first immuno-oncology clinical trial in the U.S. combining
NBTXR3 with a checkpoint inhibitor. Advancing our demonstration of
NBTXR3's potential to turn checkpoint inhibitor non-responders into
responders could be game-changing, and the approach could address
the unmet medical needs of a significant number of patients. Based
on existing pre-clinical and clinical data, NBTXR3
could become a backbone in immuno-oncology."
The IND approval enables Nanobiotix to initiate
NBTXR3-1100, a Phase I/II prospective, multi-center, open-label,
and non-randomized clinical trial evaluating the efficacy and
safety of NBTXR3 activated by SABR combined with checkpoint
inhibitors (nivolumab or pembrolizumab). NBTXR3-1100 includes three
cohorts of patients with recurrent and/or metastatic head and neck
squamous cell carcinoma (HNSCC), or with metastatic non-small
cell lung cancer (NSCLC). The study will be conducted in two
consecutive phases. The first of these will be dose escalation,
followed by a dose expansion phase. The study will seek to enroll
between 36 to 72 patients in Phase I and 40
patients in Phase II.
NBTXR3-1100's dose escalation phase is based on
a classical 3+3 Phase I study and planned as a 3-level program to
identify the appropriate dose of NBTXR3 injected into the tumor as
well as the activation dose of SABR. While NBTXR3 and Radiotherapy
doses will be escalated, the anti-PD1 antibody dose will remain
constant. One approved anti-PD1 antibody for the dose expansion
phase will be selected based on the preliminary risk-benefit ratio
assessment observed in Phase I portion of the trial.
Primary and secondary endpoints will evaluate
efficacy and safety, while exploratory endpoints further
characterize the treatment-induced genomic alterations previously
reported, including enriched cytokine activity and markers of
adaptive immune response and T-cell receptor signaling
pathways.
The NBTXR3-1100 trial will be led by
coordinating investigator Tanguy Seiwert, M.D., of The University
of Chicago Medical Center, and principal investigator Jared Weiss,
M.D., of The University of North Carolina - Chapel Hill.
The potential for immuno-oncology agents to
boost immune system response by priming it for active attack
against tumor cells has long been a source of excitement.
While 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 some cancer patients, most patients exhibit
little or no response to existing treatments.
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
current immunotherapy treatments.
The physical mode of action by which NBTXR3
works induces a different immunogenicity and could be the key to
significantly increasing the number of cancer patients who can
benefit from immuno-oncology therapies.
As presented earlier this year at ASCO &
SITC 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 available 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.
The first patient first visit in the potentially
paradigm changing trial is expected in Q2 2018 with with first
expected results in the summer of 2019.
***
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 promising 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 activated by 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 suggest that NBTXR3 activated by radiotherapy could
transform tumors into an effective in situ vaccine, opening up very
promising perspectives in the treatment of local cancer and
metastases.
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 NBTXR3
NBTXR3 is an injectable aqueous suspension of
hafnium oxide nanoparticles designed as an innovative therapeutic
agent for the treatment of solid tumors, currently in clinical
development by Nanobiotix.
Once injected intratumorally, NBTXR3 can deposit
high energy within tumors only when activated by an ionizing
radiation source, notably radiotherapy. Upon activation, the high
energy radiation is physically designed to kill the tumor cells by
triggering DNA damage and cell destruction and improve clinical
outcomes.
Promising results indicate that NBTXR3 activity
could be applicable across solid tumors triggering immunogenic cell
death, leading to an immune response, reinforcing a local and
potentially systemic effect, and contributing to transform "cold"
tumors into "hot" tumors. NBTXR3's major characteristics are
represented by a high degree of biocompatibility, one single
administration before and during the whole therapy and the ability
to fit into current standards of radiotherapy care.
NBTXR3 entered clinical development in 2011 in a
Phase I/II with patients suffering from advanced soft tissue
sarcoma of the extremities and is currently in the final stages of
its subsequent phase II/III. In parallel, it is currently being
tested in numerous Phase I/II clinical trials with patients
suffering from locally advanced squamous cell carcinoma of the oral
cavity or oropharynx (head and neck), liver cancer (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
Nanobiotix (Euronext: NANO / ISIN: FR0011341205)
is a late clinical-stage nanomedicine company pioneering novel
approaches to 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 is also running research programs 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 are 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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