Data published in Clinical and Translational
Radiation Oncology
- Peer-reviewed clinical case study reported preliminary data
on the first-in-human administration of NBTXR3 for the treatment of
pancreatic cancer not eligible for surgery, demonstrating
feasibility with no treatment-related toxicity
- Case study provides the first demonstration of local
endoscopic delivery of NBTXR3 to a deep visceral tumor, and adds to
a growing body of clinical data suggesting injection feasibility in
pancreatic cancer, head and neck cancer, lung cancer, liver cancer,
colorectal cancer, esophageal cancer, prostate cancer and soft
tissue sarcoma
Regulatory News:
NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the
‘‘Company’’), a late-stage clinical biotechnology
company pioneering physics-based approaches to expand treatment
possibilities for patients with cancer, today announced the
publication of a peer-reviewed case study by researchers at The
University of Texas MD Anderson Cancer Center in Clinical and
Translational Radiation Oncology. The case study reports on the
first patient experience of treatment with potential first-in-class
radioenhancer, NBTXR3, in pancreatic ductal adenocarcinoma (PDAC;
pancreatic cancer).
Given the nature of NBTXR3 as a therapeutic candidate with
potentially broad applicability across solid tumor indications and
therapeutic combinations, Nanobiotix and MD Anderson are
collaborating to expand development of NBTXR3 beyond the Company’s
priority pathways in locally advanced head and neck squamous cell
carcinoma and immunotherapy. This ongoing phase I pancreatic cancer
study is one of five active phase I or phase II studies currently
being conducted as part of the collaboration.
The phase I clinical trial is designed to determine the safety
profile of NBTXR3 activated by radiotherapy (RT) for patients with
locally advanced or borderline resectable PDAC, and the recommended
phase II dose (RP2D) for future efficacy evaluation. The case study
in Clinical and Translational Radiation Oncology reports on the
first patient ever to receive local endoscopic delivery of NBTXR3
to a deep visceral tumor. The patient is a 66-year-old male with
unresectable, locally advanced PDAC who received local endoscopic
delivery of NBTXR3 followed by intensity modulated RT. CT imaging
demonstrated no visible leakage of the radioenhancer outside of the
injected tumor. At initial follow-up evaluation, the lesion
remained radiographically-stable, the patient did not demonstrate
treatment-related toxicity, and the report concluded that the
treatment was feasible.
PDAC is one of the leading causes of cancer-related death in the
world today. For patients with PDAC who are not eligible for
surgery, RT has been shown to improve local disease control.
However, safely delivering therapeutic doses of radiation remains
challenging due to off-target toxicities in surrounding healthy
tissues. While systemic radiosensitizers have been evaluated in
this indication, these agents increase the sensitivity of both
tumor tissues and healthy tissues. In contrast, due to the
potential of NBTXR3 to increase the dose of RT within the tumor
without increasing the dose in surrounding healthy tissues, the
radioenhancer is being evaluated as a new option to address this
urgent unmet need.
“There is a critical need to develop an effective therapy to
improve treatment outcomes while mitigating off-target toxicities
for patients with locally advanced pancreatic cancer,” said Eugene
Koay, MD, PhD, associate professor of Radiation Oncology at MD
Anderson. “The initial feasibility for NBTXR3 injection outlined in
this case study provides an important step forward as we determine
the recommended phase II dose and the potential for the
radioenhancer to help patients with this challenging disease.”
Nanobiotix expects to establish the recommended phase II dose
for NBTXR3 in pancreatic cancer in 2022.
***
About NBTXR3 NBTXR3 is a novel, potentially
first-in-class oncology product, composed of functionalized hafnium
oxide nanoparticles that is administered via one-time intratumoral
injection and activated by radiotherapy. The product candidate’s
physics-based mechanism of action (MoA) is designed to induce
significant tumor cell death in the injected tumor when activated
by radiotherapy, subsequently triggering adaptive immune response
and long-term anti-cancer memory. Given the MoA, Nanobiotix
believes that NBTXR3 could be scalable across any solid tumor that
can be treated with radiotherapy and across any therapeutic
combination, particularly, with immune checkpoint inhibitors.
NBTXR3 is being evaluated in locally advanced head and neck
squamous cell carcinoma (HNSCC) as the primary development pathway.
The company-sponsored phase I dose escalation and dose expansion
study has produced favorable safety data and early signs of
efficacy. In February 2020, the United States Food and Drug
Administration granted 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 HNSCC who are not eligible for platinum-based
chemotherapy.
Nanobiotix has also prioritized an Immuno-Oncology development
program—beginning with a Company sponsored phase I clinical study,
evaluating NBTXR3 activated by radiotherapy in combination with
anti-PD-1 checkpoint inhibitors for patients with locoregional
recurrent or recurrent/metastatic HNSCC and for patients with lung
or liver metastases from any primary cancer eligible for anti-PD-1
therapy, either naïve or resistant to prior PD-1 (either primary or
secondary as per SITC criteria).
Given the Company’s focus areas, and balanced against the
scalable potential of NBTXR3, Nanobiotix has engaged in strategic
collaborations to expand development of the product candidate in
parallel with its priority development pathways. Pursuant to this
strategy, in 2019 Nanobiotix entered into a broad, comprehensive
clinical research collaboration with The University of Texas MD
Anderson Cancer Center to sponsor several phase I and phase II
studies to evaluate NBTXR3 across tumor types and therapeutic
combinations. In 2021, the Company entered into an additional
strategic collaboration agreement with LianBio to support its
global phase III study in Asia along with four future
registrational studies.
About NANOBIOTIX Nanobiotix is a late-stage clinical
biotechnology company pioneering disruptive, physics-based
therapeutic approaches to revolutionize treatment outcomes for
millions of patients; supported by people committed to making a
difference for humanity. The company’s philosophy is rooted in the
concept of pushing past the boundaries of what is known to expand
possibilities for human life.
Incorporated in 2003, Nanobiotix is headquartered in Paris,
France. The company also has subsidiaries in Cambridge,
Massachusetts (United States), France, Spain, Germany and
Switzerland. Nanobiotix has been listed on the regulated market of
Euronext in Paris since 2012 and on the Nasdaq Global Select Market
in New York City since December 2020.
Nanobiotix is the owner of more than 30 umbrella patents
associated with three (3) nanotechnology platforms with
applications in 1) oncology; 2) bioavailability and
biodistribution; and 3) disorders of the central nervous system.
The company's resources are primarily devoted to the development of
its lead product candidate– NBTXR3 —which is the product of its
proprietary oncology platform and has already achieved market
authorization in Europe for the treatment of patients with soft
tissue sarcoma under the brand name Hensify®.
For more information about Nanobiotix, visit us at
www.nanobiotix.com or follow us on LinkedIn and Twitter.
Disclaimer
This press release contains certain “forward-looking” statements
within the meaning of applicable securities laws, including the
Private Securities Litigation Reform Act of 1995. Forward-looking
statements may be identified by words such as “at this time,”
“anticipate,” “believe,” “expect,” “intend,” “on track,” “plan,”
“scheduled,” and “will,” or the negative of these and similar
expressions. These forward-looking statements, which are based on
our management’s current expectations and assumptions and on
information currently available to management, include statements
about the timing and progress of clinical trials, the timing of our
presentation of data, the results of our preclinical and clinical
studies and their potential implications. Such forward-looking
statements are made in light of information currently available to
us and based on assumptions that Nanobiotix considers to be
reasonable. However, these forward-looking statements are subject
to numerous risks and uncertainties, including with respect to the
risk that subsequent studies and ongoing or future clinical trials
may not generate favorable data notwithstanding positive early
clinical results and the risks associated with the evolving nature
of the duration and severity of the COVID-19 pandemic and
governmental and regulatory measures implemented in response to it.
Furthermore, many other important factors, including those
described in our Annual Report on Form 20-F filed with the U.S.
Securities and Exchange Commission (the SEC) on April 7, 2021 under
“Item 3.D. Risk Factors” and those set forth in the universal
registration document of Nanobiotix filed with the French Financial
Markets Authority (Autorité des Marchés Financiers – the AMF) on
April 7, 2021, each as updated in our Half-Year Financial Report
filed with the AMF and the SEC on September 8, 2021 (a copy of
which is available on www.nanobiotix.com), as well as other known
and unknown risks and uncertainties may adversely affect such
forward-looking statements and cause our actual results,
performance or achievements to be materially different from those
expressed or implied by the forward-looking statements. Except as
required by law, we assume no obligation to update these
forward-looking statements publicly, or to update the reasons why
actual results could differ materially from those anticipated in
the forward-looking statements, even if new information becomes
available in the future.
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Nanobiotix
Communications Department Brandon Owens VP,
Communications +1 (617) 852-4835 contact@nanobiotix.com
Investor Relations Department Kate McNeil SVP, Investor
Relations +1 (609) 678-7388 investors@nanobiotix.com
Media Relations
FR – Ulysse Communication Pierre-Louis Germain + 33 (0) 6
64 79 97 51 plgermain@ulysse-communication.com
US – Porter Novelli Dan Childs +1 (781) 888-5106
Dan.childs@porternovelli.com
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