Nanobiotix reports positive Phase I/II
preliminary data on feasibility and safety of NBTXR3 in liver
cancers trial
Good safety and feasibility of the
treatment at 10% dose level
Third indication in global development
confirming transferability across different cancers
Paris, France and Cambridge, Massachusetts,
USA, December 14, 2016 - NANOBIOTIX (Euronext: NANO - ISIN:
FR0011341205), a late clinical-stage nanomedicine company
pioneering novel approaches for the local treatment of cancer,
today announces a positive readout of initial data on the safety
and feasibility from the first patients treated in its Phase I/II
trial evaluating NBTXR3 in liver cancers, including primary
(Hepatocellular, HCC) and metastatic tumors.
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 toxicity. NBTXR3 aims to amplify the
energy dose within the tumor to offer better clinical results and
more therapeutic options 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.
Elsa Borghi, CMO of Nanobiotix: "At this stage,
the safety and feasibility data of NBTXR3 in liver cancers are
excellent. Observations are similar to the results of our more
advanced trials: Soft Tissue Sarcoma and Head and Neck cancers.
This is significant because these trials cover very different
patient and disease profiles. Based on the information gathered to
date, we anticipate that by the end of this phase, we will have
identified the appropriate conditions to use NBTXR3 in these
patients populations. Once again, all transferability data show the
potential of broad applicability of NBTXR3 for use with
radiotherapy in the treatment of solid tumors."
Preliminary data results:
- Good safety profile with no serious adverse events
recorded
Two sub-groups of patients have been treated at
10% dose of NBTXR3, with Intra Tumoral injections (IT), using
either 24 Gy or 45 Gy total radiation dose, based on patients
dosimetric constrains.
Intra-arterial injection has not been explored
so far because the Intra Tumoral (IT) injection has been shown to
be feasible and successful.
Good safety has been demonstrated within these
patients as well. To date, all treated patients have completed
their radiation therapy course, confirming good local tolerability
and no changes in liver hepatic functions (MELD Score
evaluation).
- Treatment feasibility and appropriate
distribution demonstrated
The data validate the feasibility of the
injection with a volume level equivalent to 10% of the baseline
tumor volume in both patient populations: primary cancer (HCC) and
liver metastasis.
The product appears to stay within the tumors
with no leakage in the surrounding healthy tissues from the day of
injection until end of radiotherapy treatment (illustration 1 &
2). It confirms and supports the findings reported from the
clinical trials in Soft Tissue Sarcoma or Head and Neck cancers
patients.
- 10% volume level secured, further levels
under evaluation
The 10% dose level was successfully evaluated in
HCC and metastatic patients. The 10% dose level is the recommended
NBTXR3 volume for the treatment of soft tissue sarcoma (STS) in the
act.in.sarc study (www.actinsarc.com), the most advanced indication
developed by Nanobiotix (Phase II/III).
The trial is now recruiting next dose levels to
evaluate safety and feasibility at higher doses along with
exploratory efficacy endpoints (complete Response Rate, Progression
Free Survival and Overall Survival).
-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 right 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
administration of NBTXR3 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 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.
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.
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 GaubertHead of Communication and Public
Affairs+33 (0)1 40 26 07 55contact@nanobiotix.com |
|
|
Media relations |
France -
Springbok ConsultantsMarina Rosoff+33 (0)6 71 58 00
34marina@springbok.fr |
|
EU
Outside France - Instinctif PartnersMelanie Toyne
Sewell+44 (0) 207 457 2020nanobiotix@instinctif.com |
United States -
The Ruth Group Kirsten Thomas / Chris Hippolyte+1
508-280-6592 / +1 646-536-7023Nanobiotix@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 filed with the French Financial Markets
Authority (Autorité des Marchés Financiers) under number D.16-0732
on July 22, 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
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considered material by Nanobiotix. The occurrence of all or part of
such risks could cause actual results, financial conditions,
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different from such forward-looking statements.
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