NANOBIOTIX: PROMISING DATA
FROM PHASE I/II HEAD AND NECK CANCER TRIAL WITH NBTXR3
PRESENTED AT THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY'S
ANNUAL MEETING
- Very good safety profile with no AEs and SAEs in stage
III/IV in frail patients older than 70 years old
- 7 out 9 patients had Complete
Reponse at 10% dose level or more
- Follow up shows a potential impact on long term disease
control
- Amendment filed for a dose expansion cohort of 44
additional patients
- Plan to open this study in the United
States
Paris, France and Cambridge, Massachusetts,
June 5, 2017 - NANOBIOTIX (Euronext: NANO - ISIN:
FR0011341205), a late clinical-stage nanomedicine company
pioneering new approaches to the treatment of cancer, presented the
results of the Phase I/II head and neck cancer trial with its lead
product candidate, NBTXR3, at the American Society of Clinical
Oncology (ASCO), Chicago.
Nanobiotix's Chief Medical Officer Elsa Borghi
said: "The very good level of tolerance seen so far, the absence of
Adverse Events related to the product, and the rate of Complete
Response in this population, indicates that NBTRX3 could play a key
role in the treatment of head and neck cancer. It could potentially
have a direct impact on the patients' outcome via Loco-regional
Control, Quality of Life, Safety and Overall Survival."
Illustration : 3D reconstruction of CT scan (tumor in yellow)
patient treated at a 15% dose level showing a Complete Response 7
months after the end of the treatment.
Population treatedHead and neck cancers
represent a group of aggressive cancers that appear in the mouth,
nose, sinuses and at the top of the aerodigestive tract. This
disease is a major public health concern in USA, Europe and
Asia.
Nanobiotix's Phase I/II head and neck trial
targets frail and elderly patients (more than 70 years) who have
advanced stage III/IV cancer with very limited therapeutic options.
The only available treatment for these patients is radiotherapy, as
their condition does not allow them to receive a combination of
radiotherapy and chemotherapy, which offers a better survival
outcome. These patients with radiotherapy treatment alone have a
poorer outcome with lower Response Rate, and shorter Overall
Survival. Uncontrolled tumor growth in such population will
significantly decrease patients' Quality of Life because basic
functions such as swallowing, breathing, speaking and eating are
impaired.
The use of Nanobiotix's NBTXR3 in this
population aims to provide better local and systemic desease
control and prolongs survival with the improvement of
Quality of Life.
Results presented at ASCO annual meeting
(Abstract #6080)
A phase I trial
of NBTXR3 nanoparticles activated by intensity-modulated
radiation therapy (IMRT) in the treatment of advanced-stage head
and neck squamous cell carcinoma (HNSCC). (Poster board #68,
Authors: Christophe Le Tourneau, MD, PhD, Valentin Calugaru, Thomas
Jouffroy, Jose Rodriguez, Caroline Hoffmann, Bernard Dodger, Victor
Moreno, Emiliano Calvo; Institut Curie, Paris, France; START
Madrid, FJD, Madrid, Spain; Centro Integral Oncológico Clara
Campal, Madrid, Spain).
- Primary endpoints: Safety and Feasibility
NBTXR3 has demonstrated an excellent safety
profile, with no Adverse Events (serious or not) related to the
product.The radiotherapy safety observed in the trial has been
strictly the same to the IMRT well-known toxicity. This is an
important finding, given the elderly and frail population treated
in this trial.
Additionally, the injection was demonstrated to
be feasible and appropriate as the product remained in the tumor
from the first day until the last day of radiotherapy. Marginal
passage in the blood circulation has been observed during injection
time. No leakage in the surrounding tissues have been observed. The
highest dose (22%) continues to be evaluated.
- Exploratory endpoints: efficacy and patient
outcome (follow up and duration of Response)
The Overall Response Rate (Partial Response plus
Complete Response) was evaluated as per RECIST 1.1.The first data
showed promising signs of antitumor activity. The Overall Response
Rate is 91% (10 out of 11 patients evaluable) and 7 out 9 patients
(78%) had Complete Reponse at 10% dose level or more. In
addition, the tumor response suggests a dose dependent effect
(see figure below: waterfall plot).
So far, all of the patients treated at higher
dose levels (15% and 22%) have shown a prolongated Response with no
loco-regional or distant relapse, with a medium follow up of 12
months.
Best Response obtained for patients at
different dose levels (*patient one non evaluable)
Additional findingsThe trial also showed
that most of the Complete Responses occurred between 3 and 10
months after the end of the treatment, during the follow-up period
when patients were not receiving any oncology treatments.
Interestingly late appearance of tumor Complete Response as well as
an unusual case of Pseudo Disease Progression followed by tumor
Complete Response have been observed in the study.
Given the existing pre-clinical data and recent
clinical data in Soft Tissue Sarcoma patients (abstract ASCO 2017
number e14615 http://bit.ly/2rsNi2M) showing the abiltity of NBTXR3
to trigger a specific adaptative immune pattern, Nanobiotix
will include an immulogical biomarkers analysis in this study.
Potential Value of NBTXR3 in this
indicationIn oncology, finding ways to impact overall survival
rate and quality of life with good safety is the ultimate
goal. The preliminary findings seem to show that NBTXR3 has
the potential to do this.
The excellent safety profile demonstrated thus
far in this elderly and frail population, indicates that NBTXR3
would represent a valuable option to preserve and improve
Quality of Life compared to other treatments. This safety profile
also opens up opportunities for combinations with different types
of treatment.
These encouraging results point towards a
positive improvement of loco-regional Control, impacting Overall
Survival.
Next stepsNanobiotix is filing a protocol
amendment of this study to include 44 additional patients in an
expansion to demonstrate the efficacy of NBTXR3. Nanobiotix is
opening 12-15 additional sites in Europe to expand the development
of this indication. The company plans to expand this study in the
US.
***
About NBTXR3 phase I/II trial in Head &
Neck cancerA 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). DesignThe
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 Head
and Neck 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). Arm 2 has not been
explored as the IT injection in arm 1 has been shown to be feasible
and successful.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.
About NANOBIOTIX: www.nanobiotix.com
Nanobiotix (Euronext: NANO / ISIN: FR0011341205)
is a late clinical-stage nanomedicine company pioneering novel
approaches for the 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.
NBTXR3 is being evaluated in: soft tissue
sarcoma (STS), head and neck cancers, prostate cancer, and liver
cancers (primary and metastases). Additionally, head and neck
cancer and rectal cancer trials led by Nanobiotix's Taiwanese
partner, PharmaEngine, are underway in the Asia Pacific region. The
Company has filed in August 2016 for market approval (CE Marking)
in Europe for its lead product NBTXR3.
The Company started in 2016 a new preclinical
research program in Immuno-oncology with its lead product NBTXR3,
which could have the potential to bring a new dimension to cancer
immunotherapies.
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.
Contact
Nanobiotix |
Sarah GaubertDirector, Communications & Public
Affairs+33 (0)1 40 26 07 55sarah.gaubert@nanobiotix.com
/contact@nanobiotix.com |
Noël Kurdi Director, Investor
Relations +1 (646) 241-4400 noel.kurdi@nanobiotix.com /
investors@nanobiotix.com |
Media relations |
France -
Springbok ConsultantsMarina Rosoff+33 (0)6 71 58 00
34marina@springbok.fr |
|
United States -
RooneyPartners Marion Janic +1 (212)
223-4017mjanic@rooneyco.com |
|
DisclaimerThis 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 update of the
reference document of Nanobiotix filed with the French Financial
Markets Authority (Autorité des Marchés Financiers) under number
D.16-0732-A01 on December 27, 2016 (a copy of which is available on
www.nanobiotix.com) and to the development of economic conditions,
financial markets and the markets in which Nanobiotix operates. The
forward-looking statements contained in this press release are also
subject to risks not yet known to Nanobiotix or not currently
considered material by Nanobiotix. The occurrence of all or part of
such risks could cause actual results, financial conditions,
performance or achievements of Nanobiotix to be materially
different from such forward-looking statements.
This press release and the information that it
contains do not constitute an offer to sell or subscribe for, or a
solicitation of an offer to purchase or subscribe for, Nanobiotix
shares in any country. At the moment NBTXR3 does not bear a CE mark
and is not permitted to be placed on the market or put into service
until NBTXR3 has obtained a CE mark.
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