Primary safety and feasibility
endpoints achieved
Preliminary positive signs of antitumoral
effect in all evaluable patients
Company preparing now registration
clinical plan, including EU and USA
NANOBIOTIX (Euronext: NANO - ISIN: FR0011341205), a late
clinical-stage nanomedicine company pioneering novel approaches for
the local treatment of cancer, today announced positive results
from a Phase I/II clinical trial of its lead product, NBTXR3, for
the treatment of locally advanced cancers of the oral cavity,
tongue or oropharynx (head and neck cancer, or H&N) in frail
and elderly patients. Nanobiotix's lead product, NBTXR3, is a
first-in-class nanoparticle radio-enhancer designed for direct
injection into cancerous tumors and engineered to increase the dose
and efficacy of radiotherapy without increasing toxicity or causing
damage to surrounding healthy tissues. The intended use of NBTXR3
in this head and neck cancer patient population is to improve
current radiotherapy outcomes by achieving better local control of
the tumor and improving systemic benefit as well as quality of life
(QoL). The prospective, open-label, non-randomized, multicentre,
dose escalation Phase I/II trial met its primary endpoint of safety
and tolerability of NBTXR3. Ten Head and Neck cancer patients have
been treated for the first 3 dose levels (out of 4). A Data Safety
Monitoring Board (DSMB) composed by external experts, has confirmed
the excellent safety profile, with no related serious
adverse events, the feasibility of the injection and appropriate
distribution.
The study showed promising signs of tumor
volume response in a cancer patient population with a high
unmet medical need, that cannot receive the standard of care
(radiotherapy plus chemotherapy). 7 out 7 evaluable patients had a
response with a tumor volume reduction equal or superior to 50%
(outside 2 non evaluable, patient number 10 evaluation on
going).
Based on these promising results, Nanobiotix
is currently establishing a clinical development plan, potentially
in EU and USA, which could lead to the registration of NBTXR3
for use in this indication.
Elsa Borghi, MD, CMO of Nanobiotix, commented:
"The results seen in this study are exciting. Frail and elderly
head and neck cancer patients, have few therapeutic options. Our
findings show that NBTXR3 has a very good safety profile and
promising tumor reduction, which could make a valuable difference
for these patients. We are now working to prepare the next clinical
trial."
Figure: Patient treated with NBTXR3; 3D scan reconstruction
before and after radiotherapy, showing tumor reduction and presence
of the nanoparticles in the tumor with no leakage in surrounding
healthy tissues. (In yellow Tumor. In pink NBTXR3). Laurent Levy,
CEO of Nanobiotix commented: "These results represent major
advances in the global clinical development of NBTXR3. We have now
observed homogeneity of comparable Phase I/II results between soft
tissue sarcoma and head and neck cancer, two very different
oncology indications. At this step, the behavior and effect of the
product are similar across these studies. This brings us a
significant step closer towards proving the transferability of our
approach, from one type of tumor to the other. We are enthusiastic
about the increased likelihood of being able to use NBTXR3 to treat
a large number of patients across cancer types." *** Clinical
trial: 1. Design, 2. Data and 3. Next steps for development
NBTXR3 phase I/II trial in Head & Neck cancer A
significant proportion of head and neck carcinomas in the western
world are found in the oral cavity, and the oropharynx, the
posterior continuation of the oral cavity that connects with the
nasopharynx (above) and laryngopharynx (below). These
structures play a crucial role in swallowing, breathing and
speaking. Locally advanced oropharyngeal cancers can obstruct the
airflow or infiltrate muscles or nerves, significantly disrupting
essential local functions. Response in H&N cancer patients is
related to: Age, stage, size, comorbidity, localization of the
tumor and infection by the human papilloma virus (presence versus
absence of HPV). Local control of the tumor, when possible, is
critical to preserve organ function, quality of life and has a
direct impact on the disease outcome including Progression - Free
Survival and (PFS) Overall Survival (OS).
- Design
The target population for the Phase I/II trial
are patients with locally advanced squamous cell carcinoma of the
oral cavity, tongue or oropharynx (Stage T3 and T4), who are also
classified as frail and elderly. They have a poorer prognosis as
compared to other H&N cancer patients. In this population tumor
response and local control are usually very low compare to patients
eligible for combined treatment: radiotherapy plus cisplatin.
This study has targeted patients with bulky tumors, with
significant invasion of local tissues. In order to ensure the
optimal treatment for every patient, the design of the study has
included two routes of injection of NBTXR3: intratumoral injection
and super selective intra-arterial injection. Arm 1: Intra Tumoral
(IT) injection, Dose escalation (5%, 10%, 15%, 22% of the tumor
volume). Number of patients could go up to 20 (3 to 6 patients per
dose level could be treated; 3 if no safety issues). Arm 2: Intra
Arterial (IA) injection, Dose escalation (5%, 10%, 15%, 22% of the
tumor volume). Number of patients could go up to 20 (3 to 6
patients per dose level could be treated; 3 if no safety issues).
Patients received 35 daily sessions (2GY per session) of
radiotherapy starting one day after the injection of NBTXR3 with a
total of 70Gy (standard of care). At 50Gy (71% of the total dose)
tumor volume is evaluated to assess the possibility of the patient
to continue RTx (if tumor volume shrinkage is more than 50%) and
avoid further unnecessary radiation toxicity and salvage
surgery.
2. DATA 2.1 Primary Endpoint: very
good Safety profile observed Evaluation confirm NBTXR3 has a
very good safety profile in this patient population. No Adverse
Events (AEs) related to NBTXR3 have been observed. The observed
adverse events were all related to either radiation therapy or the
disease itself. All the patients treated so far have completed
their radiation therapy, confirming very good local tolerability
profile of the product.
Numerous Adverse events have been observed in
the study, which occurrence by level and causality assessment are
presented following in table.
|
LEVEL 1
- |
LEVEL 2
- |
LEVEL 3 *- |
|
5% OF TUMOUR |
10% OF TUMOUR |
15% OF
TUMOUR |
|
VOLUME |
VOLUME |
VOLUME |
Number of patients |
3 |
3 |
4 |
AEs related to the product (NBTXR3) |
0 |
0 |
0 |
AEs related to the injection procedure |
0 |
0 |
G1 : 1 |
AEs related to radiotherapy |
G1:23 G2: 11 G3:5 |
G1:22 G2:5 G3:1 |
G1:6 G2:2 G3:1 |
AEs related to other conditions (disease,
comorbidities) |
G1:27 G2:3 G3:2 |
G1:21 G2:0 G3:1 G4:1 |
G1:8 G2:2 |
G = Grade *Treatment ongoing
Demonstrated feasibility and appropriate
distribution of the product The selection of the route of
administration is determined by the tumor size and mainly by the
topography and shape. So far, the study has demonstrated that
despite of the heterogeneity of tumors, the intratumoral injection
is feasible and very well tolerated. This is a positive finding
because the intra-tumoral injection is a shorter, simpler
procedure, than the super selective intra-arterial injection.
Moreover, it can be easily included in the medical practice. Arm 2
has not been explored as the IT injection in arm 1 has been shown
to be feasible and successful. The feasibility of NBTXR3 injection
at the first three dose levels (5%, 10% and 15% of the tumor
volume) have been validated by the Data Safety Monitoring Board
(DSMB), a safety committee of experts. Moreover, the product
appears to stay within the tumor with no leakage in the surrounding
healthy tissues from the day of injection until the end of
radiotherapy treatment. The recruitment at the fourth and last dose
level of 22% is ongoing.
Figure: Patient treated with NBTXR3; MRI
(visualization of the tumor) and CT Scan (visualization of the
nanoparticles) taken 24h after injection showing the presence of
the product within the tumor.
Figure: Patient treated with NBTXR3 (at 5% and
10%); CT Scan (visualization of the nanoparticles) showing presence
of NBTXR3 from day of injection to last day of radiotherapy
2.2 Secondary endpoint: Tumor Response
Secondary endpoints of this trial include the assessment by MRI of
the overall response, the evaluation of local progression-free
survival (LPFS) and PFS. Tumor Response has been measured during
the radiotherapy treatment after 50GY (71% of the total dose
delivered to patient) and at the end of the treatment after 70Gy
(100% of the total dose delivered to patient) by imaging using MRI.
The response is established based on tumor volume and decrease of
the longest dimension (RECIST 1.1 criteria). Promising signs of
efficacy has been reported with 7/7 patients showing tumor volume
response superior or equal to 50%. 2 patients have shown complete
or near complete tumor volume shrinkage. In the follow up of this
trial, Nanobiotix is monitoring LPFS, PFS and OS for all
patients.
Figure: Average tumor shrinkage evaluation after
5OGy and 70Gy with 5%, 10% and 15% NBTXR3 volume. 3. Next Steps
for Development A second trial has been planned that will
include NBTXR3 in combination with standard of care (SOC)
treatment, cisplatin plus radiotherapy. Currently, approximately
35-40% of patients with head and neck carcinomas receive treatment
of cisplatin with radiotherapy. Treating this group with NBTXR3
would magnify the total potential treatable population in this
indication.
Nanobiotix is currently establishing the
clinical development plan, which could lead to the registration of
NBTXR3 for use in this Head and neck patient. In addition to
H&N cancer, NBTXR3 is currently under clinical development for
soft tissue sarcoma (registration phase), prostate cancer, rectal
cancer (PharmaEngine) and liver cancers (HCC and liver metastases).
*** About NANOBIOTIX: www.nanobiotix.com
Nanobiotix (Euronext: NANO / ISIN: FR0011341205)
is a late clinical-stage nanomedicine company pioneering novel
approaches for the local treatment of cancer. The Company's
first-in-class, proprietary technology, NanoXray, enhances
radiotherapy energy with a view to provide a new, more efficient
treatment for cancer patients.
NanoXray products are compatible with current
radiotherapy treatments and are meant to treat potentially a wide
variety of solid tumors including soft tissue sarcoma, head and
neck cancers, liver cancers, prostate cancer, breast cancer,
glioblastoma, etc., via multiple routes of administration.
Nanobiotix's lead product NBTXR3, based on
NanoXray, is currently under clinical development for soft tissue
sarcoma, head and neck cancer, prostate cancer, rectal cancer
(PharmaEngine) and liver cancers (HCC and liver metastases). The
Company has partnered with PharmaEngine for clinical development
and commercialization of NBTXR3 in Asia.
Nanobiotix is listed on the regulated market of
Euronext in Paris (ISIN: FR0011341205, Euronext ticker: NANO,
Bloomberg: NANO: FP). The Company Headquarter is based in Paris,
France. Affiliate in Cambridge, United States.
For more information, please visit
www.nanobiotix.com
Contact
Nanobiotix |
|
|
Sarah Gaubert Head of Communication and Public
Affairs +33 (0)1 40 26 07 55 contact@nanobiotix.com |
|
|
Media relations |
France -
NewCap Annie-Florence Loyer +33 (0)6 88 20 35 59
afloyer@newcap.fr |
|
EU
Outside France - Instinctif Partners Melanie Toyne
Sewell +44 (0) 207 457 2020 nanobiotix@instinctif.com |
United States -
The Ruth Group Kirsten Thomas / Chris Hippolyte +1
508-280-6592 / +1 646-536-7023 Nanobiotix@theruthgroup.com |
Disclaimer
This press release contains certain
forward-looking statements concerning Nanobiotix and its business.
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 reference
document of Nanobiotix registered by the French Financial
Markets Authority (Autorité des marchés financiers) on January 12,
2016 under number R.16-001 (a copy of which is available on
www.nanobiotix.com) and to the development of economic conditions,
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forward-looking statements contained in this press release are also
subject to risks not yet known to Nanobiotix or not currently
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different from such forward-looking statements.
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