- Two new studies have received ‘Safe to Proceed’
notifications from the United States Food and Drug Administrations
and are pending activation:
- A phase II study of NBTXR3 activated by radiation and
combined with pembrolizumab for patients with recurrent or
metastatic head and neck squamous cell carcinoma with limited PD-L1
expression or refractory to PD-1 blockade
- A phase II study of reirradiation with NBTXR3 in patients
with inoperable locoregional recurrent head and neck squamous cell
carcinoma
- Following the release of positive first results from the
Company’s phase I immunotherapy trial, these trials highlight the
continued expansion of the development plan for NBTXR3 in
combination with checkpoint inhibitors and could present additional
opportunities to accelerate the pipeline
“Overcoming low response rates in cancer immunotherapy is a
major opportunity for advancement in our field. Combined with the
fact that many patients have no other options if immunotherapy does
not work, addressing this unmet medical need is critical to our
mission of treating as many patients as possible with NBTXR3. With
recent positive results from our phase I I/O trial, the pending
activation of two phases II trials evaluating NBTXR3 with
checkpoint inhibitors highlights the momentum of NBTXR3
development.” – Laurent Levy, CEO of Nanobiotix
Regulatory News:
NANOBIOTIX (Euronext: NANO - ISIN: FR0011341205 – the
“Company”) (Paris:NANO), a clinical-stage nanomedicine
company pioneering new approaches to the treatment of cancer, today
announced that the United States Food and Drug Administration (FDA)
has provided ‘Safe to Proceed’ notifications for two additional
trials in its ongoing clinical collaboration with The University of
Texas MD Anderson Cancer Center (MD Anderson). These trials were
co-developed with Nanobiotix and MD Anderson is the sponsor and
executor.
Significant Unmet Needs and Opportunity in Cancer
Immunotherapy
Cancer immunotherapies such as immune checkpoint inhibitors
(ICIs) have shown promising clinical outcomes over the past two
decades; and are often used for patients with advanced cancers once
other therapies have reached the end of their effectiveness.
However, the vast majority of patients only receive a temporary
benefit or no benefit from ICIs, as they either develop resistance
to the treatment during the course of therapy or are non-responsive
to the treatment altogether (only 15%-20% of patients respond,
according to published data). These barriers present a significant
unmet need to improve the efficacy ICIs and expand their
potentially curative benefits to more patients with advanced
cancers.
Combining ICIs with radiation therapy is emerging as a valuable
strategy to “prime” an immune response and thereby increase the
response rate, however the efficacy of radiation therapy is limited
by toxicities related to the exposure of healthy tissues.
NBTXR3 is injected one time, directly into solid tumors. The
product candidate is designed to increase the energy deposit from
radiation therapy within the target tumor and subsequently increase
the tumor-killing effect without increasing toxicity in surrounding
healthy tissue. Pre-clinical and clinical data also suggest that
NBTXR3 activated by radiation therapy can prime the immune system,
creating an anti-tumor immune response that produces both local and
systemic effects.
A Phase II Study of NBTXR3 Activated by Radiation and
Combined with Pembrolizumab for Patients with Recurrent or
Metastatic Head and Neck Squamous Cell Carcinoma with Limited PD-L1
Expression or Refractory to PD-1 Blockade
This MD Anderson trial is an open label, two cohort,
non-randomized phase II study. The primary objective of the study
is to evaluate tumor response of NBTXR3 activated by radiation
therapy in combination with pembrolizumab in patients with
recurrent or metastatic (R/M) head and neck squamous cell carcinoma
(HNSCC).
The population includes patients with inoperable R/M HNSCC of
the oropharynx, oral cavity, hypopharynx, larynx or neck. Patients
could be anti-PD-1/L1 naïve or refractory. Up to 60 patients may be
treated, with up to 40 in the first cohort and up to 20 in the
second cohort. The first cohort will include anti-PD-1/L1 naïve
patients with a combined positive score (CPS) between greater than
or equal to 1% and less than 20%. The second cohort will include
anti-PD-1/L1 refractory patients irrespective of PD-L1
expression.
A Phase II Study of Reirradiation with NBTXR3 in Patients
with Inoperable Locoregional Recurrent Head and Neck Squamous Cell
Carcinoma
This MD Anderson trial is an open label, two cohort,
non-randomized phase II study. The primary objectives of the study
are: (i) to estimate progression-free survival (PFS) and the early
clinical benefit in patients treated with NBTXR3 activated by SBRT
re-irradiation, with concurrent pembrolizumab; (ii) to assess the
safety profile and estimate the early clinical benefit of NBTXR3
activated by a reduced dose of IMRT or IMPT re-irradiation with
concurrent pembrolizumab.
The population includes patients with inoperable, locoregional
recurrent head and neck squamous cell carcinoma (HNSCC) or second
primary HNSCC, previously treated with definitive radiation therapy
and without radiographic evidence of metastases. Patients could be
anti-PD-1/L1 naïve or non-responders. Up to 80 patients may be
treated, with up to 60 in the SBRT cohort and up to 20 in the
IMRT/IMPT cohort.
***
About NBTXR3 NBTXR3 is a novel, potentially
first-in-class radioenhancer composed of functionalized hafnium
oxide nanoparticles that is administered via one-time intra-tumoral
injection and activated by radiation therapy. The primary mode of
action (MoA) of NBTXR3 is designed to generate increased cellular
destruction when activated by radiation therapy without increasing
damage to healthy tissues. Subsequently, this cellular destruction
also triggers an adaptive immune response.
NBTXR3 is being evaluated in locally advanced head and neck
squamous cell carcinoma (HNSCC) of the oral cavity or oropharynx in
elderly patients unable to receive chemotherapy or cetuximab with
limited therapeutic options. Promising results have been observed
in the phase I trial regarding local control. In the United States,
the Company has started the regulatory process to commence a phase
III clinical trial in locally advanced head and neck cancers. In
February 2020, the United States Food and Drug Administration
granted the regulatory Fast Track designation for the investigation
of NBTXR3 activated by radiation therapy, with or without
cetuximab, for the treatment of patients with locally advanced head
and neck squamous cell cancer who are not eligible for
platinum-based chemotherapy.
Nanobiotix is also running an Immuno-Oncology development
program. The Company has launched a Phase I clinical trial of
NBTXR3 activated by radiotherapy in combination with anti-PD-1
checkpoint inhibitors in locoregional recurrent (LRR) or recurrent
and metastatic (R/M) HNSCC amenable to re-irradiation of the HN and
lung or liver metastases (mets) from any primary cancer eligible
for anti-PD-1 therapy.
Other ongoing NBTXR3 trials are treating patients with
hepatocellular carcinoma (HCC) or liver metastases, locally
advanced or unresectable rectal cancer in combination with
chemotherapy, head and neck cancer in combination with concurrent
chemotherapy, and pancreatic cancer. The Company is also engaged in
a broad, comprehensive clinical research collaboration with The
University of Texas MD Anderson Cancer Center to further expand the
NBTXR3 development program.
About NANOBIOTIX: www.nanobiotix.com Incorporated in
2003, Nanobiotix is a leading, clinical-stage nanomedicine company
pioneering new approaches to significantly change patient outcomes
by bringing nanophysics to the heart of the cell.
The Nanobiotix philosophy is rooted in designing pioneering,
physical-based approaches to bring highly effective and generalized
solutions to address unmet medical needs and challenges.
Nanobiotix’s novel, proprietary lead technology, NBTXR3, aims to
expand radiotherapy benefits for millions of cancer patients.
Nanobiotix’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 in Paris, France, with a US
affiliate in Cambridge, MA, and European affiliates in France,
Spain and Germany.
Disclaimer This press release contains certain
forward-looking statements concerning Nanobiotix and its business,
including its prospects and product candidate development. 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 universal registration document of
Nanobiotix registered with the French Financial Markets Authority
(Autorité des Marchés Financiers) under number R.20-010 on May 12,
2020 (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.
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version on businesswire.com: https://www.businesswire.com/news/home/20201116005910/en/
Nanobiotix
Communications Department Brandon Owens VP,
Communications +1 (617) 852-4835 contact@nanobiotix.com
Investor Relations Department Ricky Bhajun Senior
Manager, Investor Relations +33 (0)1 79 97 29 99
investors@nanobiotix.com
Media Relations
France – Ulysse Communication Pierre-Louis Germain + 33
(0)6 64 79 97 51 plgermain@ulysse-communication.com
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