Data presented by Professor Christophe Le
Tourneau at the 2021 Annual Meeting of the American Society for
Radiation Oncology
- First survival data from Phase I Dose Expansion in
tough-to-treat elderly and frail LA-HNSCC patients ineligible for
cisplatin and intolerant to cetuximab:
- Median Overall Survival of 18.1 months in evaluable patients
(n=41) and median Progression Free Survival of 10.6 months
- Best observed target lesion objective response rate of 85.4%
and best observed target lesion complete response rate of
63.4%1
- NBTXR3 administration was feasible and well tolerated in
population with significant burden of disease and comorbidity
- Phase I dose expansion data support and inform the design of
upcoming phase III global registration trial in a larger HNSCC
population with lower comorbidities overall
Regulatory News:
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Figure 1: Best Observed Target Lesion
Response by RECIST 1.1 as per Investigator Assessment (Graphic:
Business Wire)
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 first ever
survival data from its priority head and neck cancer development
program at the 2021 Annual Meeting of the American Society for
Radiation Oncology (ASTRO).
As specified by the ASTRO Annual Meeting embargo policy,
“information beyond what is included in the abstract, such as
updated or additional results, is embargoed until the date and time
of scientific presentation or presentation at an ASTRO news
briefing, whichever occurs first.” However, Nanobiotix has become
aware that ASTRO made a late decision to release the posters at the
same time as the abstracts and did not sufficiently update the
embargo policy. As a result, the Company is releasing this data in
advance of its intended embargo date.
New Data from Locally Advanced Head and Neck Squamous Cell
Carcinoma (LA-HNSCC) Program
Data show a median Overall Survival (mOS) of 18.1 months and a
median Progression Free survival of (mPFS) of 10.6 months in the
evaluable population (n=41) from the dose expansion part of its
phase I, multicenter, open-label, non-randomized dose escalation
and dose expansion study evaluating NBTXR3 as a single-agent
activated by radiotherapy in tough-to-treat elderly and frail
LA-HNSCC patients ineligible for cisplatin and intolerant to
cetuximab (Study 102 Expansion). In the full population (all
evaluable and non-evaluable patients treated; n=54), data showed a
14.1-month mOS and a 9.4-month mPFS. The data suggest that lower
mOS and mPFS observed in the full population versus the evaluable
population in the study could be related to early death associated
with high burden of comorbidity in the non-evaluable
population.
Evaluability in Study 102 Expansion was determined based on the
patient receiving at least 80% of the intended intratumoral dose of
NBTXR3, at least 60 Gy of radiotherapy, and the required imaging to
assess the target lesion at baseline and at least once post
treatment.
Response rates remained consistent with previously reported
results from the dose escalation and dose expansion study, showing
a best observed target lesion objective response rate (ORR) of
85.4% and a best observed target lesion complete response rate
(CRR) of 63.4%2.
“I have held the belief that NBTXR3 could have a real impact for
patients with solid tumors since reviewing the proof-of-concept
data from the phase II/III in soft tissue sarcoma and throughout my
participation in Study 102 Expansion,” said study principal
investigator Professor Christophe Le Tourneau, senior medical
oncologist and head of the Department of Drug Development and
Innovation (D3i) at Institut Curie. “This first look at survival
data has added to my confidence that NBTXR3 could provide a
promising new therapeutic option for the practice. I look forward
to leading the upcoming phase III global registration study, and to
have the opportunity to evaluate the promise of this innovation in
a larger patient population.”
Of the 21 evaluable patients with a best observed overall
response of complete response (CR) with a mean follow-up of 16.1
months, 6 patients died for non-oncologic reasons and only one died
from disease progression.
NBTXR3 administration was feasible and well-tolerated overall. A
total of 8 Grade 3-4 NBTXR3-related adverse events (AEs) were
observed in 8 patients, representing 1.3% of all observed AEs. Of
these AEs related to NBTXR3, 5 serious adverse events (SAEs) were
observed including dysphagia, sepsis, soft tissue necrosis,
stomatitis, and tumor hemorrhage. Of the SAEs, one death from
sepsis assessed by the investigator as possibly related to NBTXR3,
radiotherapy, and cancer was observed.
While the incidence of LA-HNSCC has continued to rise, patients
in the elderly and frail LA-HNSCC population have significant unmet
needs. Many are not eligible to receive concurrent chemoradiation
due to frailty associated with comorbidities. The modified Charlson
Comorbidity Index (mCCI) is a measure of comorbidity burden on a
patient-by-patient basis, and high mCCI (i.e., mCCI ≥ 4) is
correlated with higher risk of death relative to the broader
population. In this study, 63% of all patients treated had high
mCCI, which is two to three times the prevalence of comorbidity in
the overall LA-HNSCC population3.
Despite the prevalence of high mCCI in Study 102 Expansion,
these preliminary data support further evaluation of NBTXR3
activated by radiotherapy as a therapeutic option that may
translate to a survival benefit for elderly and frail LA-HNSCC
patients. The data also suggest that the potential benefits of the
therapy could improve in a population with a lower burden of
comorbidity.
“Bringing innovation to the patients that need it most has
always been the backbone of our development strategy for NBTXR3,”
said Laurent Levy, co-founder and chief executive officer of
Nanobiotix. “We started with soft tissue sarcoma—a disease
indication notoriously resistant to radiotherapy. After proving we
could provide a therapeutic benefit versus radiotherapy alone for
patients with locally advanced disease and achieving European
market approval, we pivoted to patients with locally advanced head
and neck cancer that have substantially limited treatment options.
The new survival data we are seeing from Study 102 Expansion
bolster our confidence in the promise of NBTXR3 as we near the
launch of our pivotal phase III study in head and neck cancer. We
have designed this study with the benefit of our learnings from the
phase I and look forward to the opportunity to prove that our
product candidate can expand treatment possibilities for patients
with cancer around the world.”
***
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 anti-cancer
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 the launch of a phase III global registrational study
is planned. 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. 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.
_________________________________
1 Calculations include one patient marked
** in Figure 1 assessed as Complete Response by principal
investigator per eCRF
2 Calculations include one patient marked
** in Figure 1 assessed as Complete Response by principal
investigator per eCRF
3 Zumsteg ZS, et al., Cancer
2017;123:1345-53
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version on businesswire.com: https://www.businesswire.com/news/home/20211024005038/en/
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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