NANOBIOTIX Provides Third Quarter Operational and Financial Update
October 20 2021 - 4:15PM
Business Wire
- Published preclinical data in Red Journal supporting the
hypothesis that NBTXR3 activated by radiotherapy in combination
with anti-PD-1 could effectively control primary and metastatic
tumors, evoke abscopal effect, and reduce the possibility of
developing distant lung metastases
- Scheduled to present first survival data from priority head and
neck cancer program at the 2021 Annual Meeting of the American
Society for Radiation Oncology (ASTRO)
- On-track to activate first clinical trial sites in pivotal
phase III global registration study, NANORAY-312, in locally
advanced head and neck squamous cell carcinoma (LA-HNSCC) in the
coming weeks
- Reported €89.8 million in cash, cash equivalents, and
short-term investments as of September 30, 2021
Regulatory News:
NANOBIOTIX (Euronext: NANO - NASDAQ: NBTX - the
‘‘Company’’), a late-clinical stage biotechnology company
pioneering physics-based approaches to expand treatment
possibilities for patients with cancer, today announced operational
progress and cash position (unaudited) for the third quarter of
2021.
Third Quarter Financial Updates
Nanobiotix reported cash, cash equivalents, and short-term
investments totaling €89.8 million as of September 30, 2021,
compared to €119.2M as of December 31, 20201.
Third Quarter Operational Highlights and Upcoming
Milestones
- Published preclinical findings with The University of Texas
MD Anderson Cancer Center (MD Anderson) in the International
Journal of Radiation Oncology, Biology, Physics (Red Journal)
supporting continued exploration of NBTXR3 as a potential
therapeutic option to induce significant tumor cell death, prime
immune response, and overcome resistance to anti-PD-1.
- Study hypothesized that NBTXR3 in combination with radiotherapy
and anti-PD-1 could transform irradiated tumors into
“self-vaccines” in anti-PD-1-sensitive and anti-PD-1-resistant
mouse models
- Data supported the hypothesis that the triple combination could
effectively control primary and metastatic tumors, evoke abscopal
effect, and reduce the possibility of developing distant lung
metastases
- Presenting two oral presentations and three poster
presentations at the 2021 ASTRO Annual Meeting being held October
24-27, 2021, including:
- First analysis of progression free survival (PFS) and overall
survival (OS) from 41 evaluable patients from Study 102 Expansion,
a phase I dose expansion study evaluating NBTXR3 as a single agent
activated by radiotherapy in LA-HNSCC
- Updated data including approximately 16 evaluable patients from
Study 1100, a phase I basket study evaluating NBTXR3 activated by
radiotherapy in combination with nivolumab or pembrolizumab in
locoregional recurrent or recurrent metastatic HNSCC, lung
metastasis from any primary tumor and/or liver metastasis from any
primary tumor
- Long-term safety data from the phase II/III Act.In.Sarc Trial
of NBTXR3 in locally advanced soft tissue sarcoma
- Preclinical data on NBTXR3 plus anti-PD-1 in lung cancer
model
- Preparing to activate first clinical trial sites for
NANORAY-312, a pivotal phase III global registration study
evaluating NBTXR3 as a single-agent activated by radiotherapy for
patients with LA-HNSCC
- First site activations in Europe expected in the coming weeks
with first patient randomized by early 2022.
- US site activation and enrollment planned for 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 physical 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 anticancer
memory. Given the physical MoA, Nanobiotix believes that NBTXR3
could be scalable across any solid tumor that can be treated with
radiotherapy and across any therapeutic combination, particularly
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; and a phase III global registrational study is planned to
launch in 2021. 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—the same population being evaluated in the planned
phase III study.
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 lung or liver
metastases from any primary cancer eligible for anti-PD-1
therapy.
Given the Company’s focus areas, and balanced against the
scalable potential of NBTXR3, Nanobiotix has engaged in a strategic
collaboration strategy with world class partners 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.
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, and Germany.
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, the development and
commercialization of NBTXR3, and the execution of the Company’s
development and commercialization strategy. 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
preclinical or early clinical result 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 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”, those set forth in the
universal registration document of Nanobiotix filed with the French
Financial Markets Authority (Autorité des marchés financiers or
“AMF”) under number D.21-0272 on April 7, 2021 (a copy of which is
available on www.nanobiotix.com), each as updated in the 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.
_____________________ 1 It being specified that the company did
not generate any revenue during the third quarter of 2021, this
following the termination of the PharmaEngine partnership.
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version on businesswire.com: https://www.businesswire.com/news/home/20211020005995/en/
Nanobiotix Nanobiotix Communications Brandon Owens VP,
Communications +1 (617) 852-4835 contact@nanobiotix.com
Nanobiotix Investor Relations Kate McNeil SVP, Investor
Relations +1 (609) 678-7388 investors@nanobiotix.com Media
Relations France - Ulysse Communication Pierre-Louis Germain
+ 33 (0) 6 64 79 97 51 plgermain@ulyssecommunication.com US -
Porter Novelli Dan Childs +1 (781) 888-5106
dan.childs@porternovelli.com
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