Data reported at the 2022 Annual Meeting of
the American Society for Clinical Oncology
- NBTXR3 is being developed as a product candidate with potential
to integrate across the standards of care in oncology, and these
data from collaborator-sponsored phase 1b/2 studies add support for
the radioenhancer in combination with chemoradiation and in the
preoperative setting
- Data from the phase 1b/2 head and neck cancer study in 12
evaluable patients with stage 4 disease showed that combining
NBTXR3 with concurrent chemoradiation was feasible, had a favorable
safety profile, produced a 100% disease control rate, and an
overall response rate of 58.3%
- Data from the phase 1b/2 rectal cancer study in 31 evaluable
patients with unresectable disease showed that combining NBTXR3
with concurrent chemoradiation in the preoperative setting was
feasible, had a favorable safety profile, enabled 96% of evaluable
patients to undergo R0 surgery, produced a 100% disease-control
rate, a 35.5% overall response rate, and a 20% pathological
complete response rate in 25 patients who underwent surgery
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 the
reporting of new data at the 2022 Annual Meeting of the American
Society for Clinical Oncology (ASCO) featuring potential
first-in-class radioenhancer NBTXR3 in combination with concurrent
chemoradiation for the treatment of head and neck cancer and rectal
cancer. Nanobiotix also presented a trial-in-progress poster on the
study design of the Company's ongoing pivotal phase 3 study,
NANORAY-312, evaluating NBTXR3 as a single agent activated by
radiotherapy for the treatment of elderly and frail patients with
locally advanced head and neck squamous cell carcinoma (LA-HNSCC)
who are ineligible for platinum-based chemotherapy (cisplatin).
In view of the Company's strategy for development of NBTXR3 as a
product candidate that can integrate across solid tumor indications
along with major treatment modalities within each indication,
starting with head and neck cancer, the company believes these new
data add support for the radioenhancer in combination with
chemoradiation and as a neoadjuvant (preoperative) therapy with the
potential to improve surgical outcomes. "Revolutionizing treatment
outcomes for millions of patients with cancer will require
integration of NBTXR3 across solid tumor indications, treatment
modalities, and lines of therapy where radiation is a part of the
treatment regimen—starting with head and neck cancer," said Laurent
Levy, co-founder and chairman of the executive board at Nanobiotix.
"Taken together with the clinical data we have already produced for
NBTXR3 as a single agent activated by radiotherapy and as a
combination agent with anti-PD-1, we view the new chemoradiation
data presented at ASCO as critical validation of NBTXR3's
feasibility across the standard of care. As we continue to
prioritize our ongoing pivotal phase 3 study for elderly and frail
patients with locally advanced head and neck squamous cell
carcinoma, our aim is to build a comprehensive approach to the
treatment of patients with locally advanced head and neck cancer
that will serve as a model for our radioenhancer in other
indications."
A Comprehensive Approach to Locally
Advanced Head and Neck Cancer Inclusive of
Chemoradiation
Most cisplatin-eligible patients with LA-HNSCC receive
multimodal therapy including high dose concurrent chemoradiation
(CCRT) as the standard of care. While CCRT has shown to improve
local control and extend survival, the toxicity of high dose
cisplatin creates challenges. These challenges appear both in terms
of compliance with the treatment regimen for patients undergoing
therapy that can impair efficacy, and in terms of the patients'
quality of life after treatment. Although changes to the treatment
protocol have been explored in randomized studies to reduce
toxicity and improve compliance, reduction in toxicity has also led
to reduction in efficacy.
These patients need innovative new therapeutic options that do
not create additional burden in their administration, do not add
combined toxicity to radiotherapy and chemotherapy, and have the
potential to improve survival.
A Phase 1b/2 Study Evaluating NBTXR3 in
Combination with Concurrent Chemoradiation for Patients with
Locally Advanced or Recurrent Head and Neck Squamous Cell
Carcinoma
This study, sponsored, executed, and reported by former
Nanobiotix collaborator in Asia, PharmaEngine, Inc. (PEI), sought
to evaluate the safety and feasibility of NBTXR3 intratumoral
injection when added to low-dose weekly cisplatin-containing CCRT
for patients with locally advanced or recurrent head and neck
squamous cell carcinoma. The study also aimed to establish the
recommended phase 2 dose (RP2D), however the RP2D was not
determined due to stoppage of the phase 1b part of the trial
resulting from the conclusion of the collaboration between PEI and
Nanobiotix in 2021.
Adult patients with T3-4 LA-HNSCC suitable for cisplatin were
eligible for the study and 12 such patients were enrolled. These
patients received a single intratumoral injection of NBTXR3,
followed by a low-dose weekly regimen of CCRT. All 12 patients were
deemed evaluable and all had stage 4 locally advanced disease.
Of these evaluable patients, 3, 6, and 3 patients received
NBTXR3 at the 5%, 10%, and 15% dose levels, respectively. No
serious adverse events (SAEs) inconsistent with what would normally
be expected from a low-dose CCRT regimen were observed.
Dose-limiting toxicities of grade 3 increased ALT and grade 3
increased AST were observed in one patient at the 10% dose level.
Common Grade 3 adverse events (AEs) observed across dose levels
were stomatitis, decreased WBC, decreased appetite, decreased
neutrophil count, and leukopenia. One patient experienced grade 4
hyponatremia.
Preliminary efficacy results showed a disease control rate of
100%, with an overall response rate of 58.3% according to RECIST
1.1. The study concluded that adding a single intratumoral
injection of NBTXR3 to weekly low dose cisplatin-containing CCRT
was feasible and had a favorable safety profile for patients with
LA-HNSCC.
Strengthening Support for NBTXR3 in
Combination with Chemoradiation in the Preoperative
Setting
Colorectal cancer (CRC) is the third most common cancer
indication worldwide and the second leading cause of cancer-related
death in the United States. One-third of CRCs appear in the rectum.
For patients with locally advanced rectal cancer (LARC), combined
modality therapy with neoadjuvant CCRT, followed by total
mesorectal excision (TME; surgery), followed by adjuvant
(post-operative) systemic chemotherapy is the current standard of
care. The aim of the neoadjuvant portion of the treatment regimen
is to control and downstage the disease to allow for R0 TME
(surgical removal with a negative margin in which no gross or
microscopic tumor remains in the primary tumor bed), as clinical
studies have shown a positive correlation between improved
cancer-specific survival and R0 TME. While outcomes have improved,
patients are still faced with a highly toxic treatment regimen that
can lead to a lack of compliance which may hamper efficacy, along
with deteriorated quality of life after treatment.
Innovation with the potential to improve the rate of R0
resection without adding toxicity is an urgent need for this
patient population.
A Phase 1b/2 Study Evaluating NBTXR3 in
Combination with Concurrent Chemoradiation in the Neoadjuvant
Setting for Patients with Locally Advanced or Unresectable Rectal
Cancer
This study, sponsored, executed, and presented by PEI, sought to
evaluate safety, feasibility, and early signs of efficacy for
neoadjuvant NBTXR3 combined with CCRT followed by surgery for
patients with locally advanced or unresectable rectal cancer. The
study established the recommended phase 2 dose of NBTXR3 at 22% of
gross tumor volume, however the phase 2 part of the trial was
stopped as a result of the conclusion of the collaboration between
PEI and Nanobiotix in 2021. Adult and older patients with T3-T4
locally advanced or unresectable rectal cancer suitable for
chemoradiation were eligible for the study and 32 such patients
were enrolled. These patients received a single intratumoral
injection of NBTXR3, followed by a weekly regimen of CCRT. 31 of 32
patients were deemed evaluable and none of the evaluable patients
had tumors eligible for surgery at the time of diagnosis.
Of the 31 evaluable patients, 6, 4, 3, and 18 patients received
NBTXR3 at the 5%, 10%, 15%, and 22% dose levels, respectively. No
NBTXR3-related SAEs or grade ≥ 3 AEs were observed. The most
frequently reported AEs were grade 1 or 2 decreased WBC, diarrhea,
increased CRP, UTI, and decreased lymphocyte count which were all
consistent with what would normally be expected from CCRT.
Preliminary efficacy results showed a disease control rate of
100%, with an overall response rate of 35.5% according to RECIST
1.1. Pathological tumor downstaging was observed in 14 of 31
patients after therapy, 25 patients underwent surgery, and 96% of
those patients achieved R0 surgical margins. Pathological complete
response was observed in 20% of the patients who received surgery.
The study concluded that a single intratumoral injection of NBTXR3
in combination with CCRT is feasible and has a favorable safety
profile in the neoadjuvant setting for patients with locally
advanced or unresectable rectal adenocarcinoma.
***
About NBTXR3
NBTXR3 is a novel, potentially first-in-class oncology product
composed of functionalized hafnium oxide nanoparticles 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.
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 is leveraging its proprietary nanoparticle platform,
including its lead product candidate, radiotherapy activated
NBTXR3, to develop a pipeline of therapeutic options designed to
enhance local and systemic control of solid tumors with an initial
focus on the treatment of head and neck cancers.
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 8, 2022 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 8, 2022, 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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version on businesswire.com: https://www.businesswire.com/news/home/20220605005062/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 Caitlin Hunt +1 (781) 985-5967
Caitlin.hunt@porternovelli.com
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