NANOBIOTIX PRESENTS FIRST PROMISING
DATA FROM PHASE I/II LIVER CANCERS TRIAL OF
NBTXR3 AT THE AMERICAN SOCIETY OF CLINICAL
ONCOLOGY GASTROINTESTINAL ANNUAL
MEETING
- Very good safety profile with no AEs and SAEs related
to NBTXR3
- Complete Response achieved in 3 out of
7 patients evaluable and partial response achieved in 3 out of 7,
among 10 patients treated
- Third indication in global NBTXR3 development
confirming transferability across different cancers
Paris, France and Cambridge, Massachusetts,
USA, Monday January 22, 2018 - NANOBIOTIX (Euronext: NANO -
ISIN: FR0011341205), a late clinical-stage nanomedicine company
pioneering new approaches to the treatment of cancer, today
announces a first readout of intermediate data on the safety and
feasibility in its Phase I/II trial evaluating NBTXR3 in liver
cancers, including primary (Hepatocellular, HCC) and liver
metastasis from other tumors.
Nanobiotix Chief Medical Officer Elsa Borghi,
said: "This study successfully demonstrated the safety and the
feasibility of the treatment for two different and important
indications in liver oncology. These results open a promising
pathway for NBTXR3 in patients highly vulnerable."
Population treated Patients with either
HCC or liver metastases frequently cannot undergo surgery and have
very few or no therapeutic options available. Radiation therapy has
been shown to improve outcomes of these patients. Clinical trials
have shown a direct correlation between higher doses of radiation
therapy and increased survival, in both patient populations. The
delivery of a high radiation dose is complex and cannot be done in
an optimal way in most situations due to radiation therapy
associated toxicity. NBTXR3 aims to amplify the energy dose within
the tumor to offer better clinical results and to improve the poor
prognosis of these populations.
Nanobiotix's Phase I/II trial evaluates the
safety and preliminary efficacy of NBTXR3 nanoparticles
administrated by intra-tumoral (IT) or intra-arterial (IA)
injection and activated by high precision radiation therapy,
delivered as high dose fractions (Stereotactic Body Radiation
Therapy (SBRT)) for the treatment of liver cancers.
Results presented at ASCO GI annual
meeting (Abstract #202303)A phase I/II trial of NBTXR3
nanoparticles activated by SBRT in the treatment of liver
cancers. (Poster board ID TPS 551, Authors: Enrique Chajon,
Marc Pracht, Thierry De Baere, France Nguyen, Jean-Pierre
Bronowicki, Veronique Vendrely, Anne-Sophie Baumann, Valérie
Croisé-Laurent, Eric Deutsch; Centre Hospitalier Universitaire de
Rennes, Rennes, France; Centre Eugene MARQUIS, Rennes, France;
Department of Imaging and Therapeutic Imaging, Gustave Roussy and
Paris-Sud University, Villejuif, France; Institut Gustave Roussy,
Villejuif, France; INSERM 954, CHU de Nancy, Université de
Lorraine, Nancy, France; CHU Bordeaux, Bordeaux, France; Institut
de Cancérologie de Lorraine, Nancy, France).
Enrollment was completed for dose levels 10% (6
pts) and 15% (4 pts). The recruitment at 22% which is the third
dose level, is ongoing.
- Primary endpoints: Safety and Feasibility
The product has demonstrated a very
good safety profile, with no adverse event (serious or not)
related to NBTXR3 occurred and no dose-limiting toxicity (DLT).
Additionally, the NBTXR3 injections have been
demonstrated to be feasible with successful injections in all
cases, a good dispersion of the product and the confirmation of its
permanence within the tumor structure, from the first day until the
last day of radiotherapy treatment, with no negative effect related
to the treatment.
Importantly, NBTXR3 nanoparticles did not have
any impact on the reliability of image-guided radiation therapy
(IGRT).
- Secondary endpoint: Overall response rate to
date
Best
Overall Response data to date, presented in the table below are
based on local assessment on target lesions by mRECIST via MRI.
Out of 10 patients treated, 7 are evaluable. Out
of these 7 patients, 3 achieved a complete response and 3 a partial
response as best overall response.
These data are only first preliminary response
data which will be completed with additional data.
Data
presented are based on local assessment on target lesions by
mRECIST via MRI.
- Potential value of NBTXR3 in this
indication
The physical mode of action of NBTXR3 may
represent a breakthrough approach for the local treatment of liver
cancers, as it does not engage liver and renal functions, i.e.
nanoparticles are neither metabolized by the liver nor excreted by
the kidney, which is key and highly valuable.
- Next steps
The
trial is planned to evaluate patients at 10, 15, 22 and 33% NBTXR3
dose level. The two first levels (10 and 15%) have been completed,
and the trial is recruiting patients to be treated at 22%.
NBTXR3 is also being evaluated in: soft tissue
sarcoma (STS), head and neck cancers and prostate cancer.
Additionally, head and neck cancer and rectal cancer trials led by
Nanobiotix's Taiwanese partner, PharmaEngine, are underway in the
Asia Pacific region.
-ends-
About liver cancers
According to WHO, liver cancers are the second
most common cause of cancer death in the world with 745,000 deaths
each year, and 800,000 new liver cancer patients per year.
Liver cancers are challenging diseases to
address. Stereotactic Body Radiation Therapy (SBRT) is the safest
and most modern radiotherapy currently available for the treatment
of malignant liver tumors but SBRT has been shown to be efficient
only in specific subsets of population with small tumors. Complete
response is a rare event and local control is often compromised in
big tumors, metastases and HCC with portal vein tumor thrombosis
and short progression Free Survival and Overall survival.
About NBTXR3 trial protocol in liver
cancer
NBTXR3 is a first-in-class radio-enhancer
nanoparticle designed for direct injection into malignant tumors.
NBTXR3 has the potential to improve radiotherapy efficacy by
destroying locally advanced cancers more efficiently. It has been
engineered to increase the local absorption of the radiotherapy
dose and thereby increasing the efficacy of radiotherapy without
increasing toxicity or causing damage to surrounding healthy
tissues.
The first phase of the ongoing, multicenter
open-label, single-arm study is a dose-escalation to evaluate the
safety, feasibility and preliminary clinical activity along with
determining the recommended dose of NBTXR3 in this indication. The
second phase of the trial will be a dose-expansion phase, which
will be a cohort expansion at the recommended dose of NBTXR3.
Patients receive a single injection of NBTXR3
into the tumor or metastasis 24 hours before the beginning of the
radiotherapy treatment. The total maximum radiotherapy dose is 45
Gy, delivered as three fractions of 15 Gy each, over 5 to 7
days.
About NBTXR3
NBTXR3 is an injectable aqueous suspension of
hafnium oxide nanoparticles designed as an innovative therapeutic
agent for the treatment of solid tumors, currently in clinical
development by Nanobiotix.
Once injected intratumorally, NBTXR3 can deposit
high energy within tumors only when activated by an ionizing
radiation source, notably radiotherapy. Upon activation, the high
energy radiation is physically designed to kill the tumor cells by
triggering DNA damage and cell destruction and improve clinical
outcomes.
Promising results indicate that NBTXR3 activity
could be applicable across solid tumors triggering immunogenic cell
death, leading to an immune response, reinforcing a local and
potentially systemic effect, and contributing to transform "cold"
tumors into "hot" tumors. NBTXR3's major characteristics are
represented by a high degree of biocompatibility, one single
administration before and during the whole therapy and the ability
to fit into current standards of radiotherapy care.
NBTXR3 entered clinical development in 2011 in a
Phase I/II with patients suffering from advanced soft tissue
sarcoma of the extremities and is currently in the final stages of
its subsequent phase II/III. In parallel, it is currently being
tested in numerous Phase I/II clinical trials with patients
suffering from locally advanced squamous cell carcinoma of the oral
cavity or oropharynx (head and neck), liver cancer (hepatocellular
carcinoma and liver metastasis), locally advanced or unresectable
rectal cancer in combination with chemotherapy, head and neck
cancer in combination with concurrent chemotherapy, and prostate
adenocarcinoma.
About NANOBIOTIX:
www.nanobiotix.com
Nanobiotix (Euronext: NANO / ISIN: FR0011341205)
is a late clinical-stage nanomedicine company pioneering novel
approaches to the treatment of cancer. The Company's
first-in-class, proprietary technology, NanoXray, enhances
radiotherapy energy with a view to providing 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 is also running research programs in
immuno-oncology, with its lead product NBTXR3, which could have the
potential to bring a new dimension to cancer immunotherapies.
Nanobiotix received FDA's approval to launch a clinical study of
NBTXR3 activated by Radiotherapy in combination with anti-PD1
antibody in lung, and head and neck cancer patients in the U.S.
Nanobiotix is listed on the regulated market of
Euronext in Paris (ISIN: FR0011341205, Euronext ticker: NANO,
Bloomberg: NANO: FP). The Company's Headquarters are based in
Paris, France, with a U.S. affiliate in Cambridge, MA.
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 |
|
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 filed with the French Financial Markets
Authority (Autorité des Marchés Financiers) under number D.17-0470
on April 28, 2017 (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.
Nanobiotix (EU:NANO)
Gráfica de Acción Histórica
De Abr 2024 a May 2024
Nanobiotix (EU:NANO)
Gráfica de Acción Histórica
De May 2023 a May 2024