Nanobiotix: Update on Head and Neck Phase I/II Trial with NBTXR3 and Other program data presented at ImmunoRad 2018
20 Septembre 2018 - 4:04AM
Nanobiotix: Update on Head and Neck Phase
I/II Trial with NBTXR3 and Other program data presented at
ImmunoRad 2018
- Strengthening of NBTXR3 data showing the potential
impact on survival in elderly and frail patients with locally
advanced head and neck cancers
- Biomarker analysis from soft tissue sarcoma clinical
trial and new preclinical data supporting NBTXR3 mechanism of
action in immune-oncology and its use in combination with immune
checkpoint inhibitors
Paris, France and Cambridge,
Massachusetts, USA, September 20, 2018 –
NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a late
clinical-stage nanomedicine company pioneering new approaches to
the treatment of cancer, today announces it will present an update
on and data from its NBTXR3 development program at the
International Conference on Immunotherapy Radiotherapy Combinations
that will take place from September 20 to 22, 2018 in Paris,
France.
Follow-up of Phase I/II in advanced Head
and Neck cancers in elderly and frail patients ineligible for
cisplatin or intolerant to cetuximabIn the Phase I part of
this trial, which is conducted to determinate the recommended dose,
18 patients have been injected with NBTXR3. Follow-up of patients
that received highest doses of NBTXR3 (15% and 22% dose levels)
shows that every patient alive at the 12-month cut-off date was
still alive after 23 months or more. At 26 months, one of the
patients treated at the 15% dose level had died. These data suggest
the potential of NBTXR3 to impact survival for this advanced cancer
patient population.
Immuno biomarker study in randomized
phase II/III soft tissue sarcoma clinical
trialImmunohistochemistry analyses revealed that, compared
to radiation therapy alone (29 patients), NBTXR3 activated by
radiation therapy (23 patients) increased the density of CD8+ T
cell lymphocyte, and decreased FOXP3+ (Treg) into the tumors, while
macrophage number remained relatively constant. These data indicate
that NBTXR3 activated by radiation therapy could modulate the
antitumor immune response.
In vivo investigation
of NBTXR3 mode of action inducing distant immune response on CT26
tumoral modelDepletion experiment of CD8+ T cells
(NBTXR3+3x4Gy+anti-CD8) induces a partial loss of tumor growth
control of treated tumors, and a complete abolition of the abscopal
effect (distal tumors). This result indicates that the abscopal
effect was driven by CD8+ T cells. Interestingly, depletion of CD4+
T cells (NBTXR3+3x4Gy+anti-CD4) increases the efficacy of NBTXR3 +
radiation therapy at both sites (treated and distal tumors). As
anti-CD4 treatment lead to Treg depletion (known to have a
protumoral role), Treg depletion might have improved NBTXR3
radiation therapy treatment. These observations continue to support
the rationale for the use of NBTXR3 activated by radiation therapy
to seek to transform tumors into an in situ cancer vaccine and its
potential use in combination with immunotherapeutic agents.
International Conference on
Immunotherapy Radiotherapy Combinations September 20 to
22, 2018 - Paris,
Francehttp://www.radio-immuno.siricsocrate.fr/en/.
●●●
About NBTXR3NBTXR3 is a
first-in-class product designed to destroy, when activated by
radiotherapy:
- tumors through physical cell death
- metastasis due to immunogenic cell death leading to activation
of the immune system
NBTXR3 has a high degree of biocompatibility,
requires one single administration before the whole radiotherapy
treatment and Nanobiotix believes has the ability to fit into
current worldwide standards of radiation care.
Nanobiotix’s broad clinical program includes 10
patient population evaluated in 7 clinical trials.In June 2018,
Nanobiotix established human proof of concept for this
first-in-class product in its Soft tissue Sarcoma Phase III
clinical trial.
NBTXR3 is actively being evaluated in head and
neck cancer with locally advanced squamous cell carcinoma of the
oral cavity or oropharynx in elderly and frail patients that are
unable to receive chemotherapy or cetuximab with very limited
therapeutic options. The Phase I/II trial has already delivered
very promising results regarding the local control of the
tumors.
Nanobiotix is running an Immuno-Oncology
development program . In the United States., Nanobiotix has
received the FDA’s approval to launch a clinical study of NBTXR3
activated by radiotherapy in combination with anti-PD1 antibodies
in lung, and head and neck cancer patients (head and neck squamous
cell carcinoma and non-small cell lung cancer).
The other ongoing NBTXR3 studies are treating
patients with liver cancers (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.
The first market authorization process (CE
Marking) is ongoing in Europe in the soft tissue sarcoma
indication.
About
NANOBIOTIX: www.nanobiotix.com
Incorporated in 2003, Nanobiotix is a leading, late clinical-stage
nanomedicine company pioneering new approaches to significantly
change patient outcomes by bringing nanophysics to the heart of the
cell.
The Nanobiotix philosophy is one rooted in
designing pioneer physical based approaches to bring highly
effective and generalized solutions to address high unmet medical
needs and challenges.
Nanobiotix’s first-in-class, proprietary lead
technology, NanoXray, aims to expand radiotherapy benefits for
millions of cancer patients. Furthermore, Nanobiotix’s
Immuno-Oncology program has the potential to bring a new dimension
to cancer immunotherapies.
Nanobiotix is listed on the regulated market of
Euronext in Paris (Euronext: NANO / ISIN: FR0011341205; Bloomberg:
NANO: FP). The Company’s Headquarters are based in Paris, France,
with a U.S. affiliate in Cambridge, MA, and european affiliates in
Spain and Germany.
Contact
Nanobiotix |
Sarah GaubertDirector,
Communication & 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 |
Ricky Bhajun
Investor Relations Europe +33 (0)1 79 97 29 99
ricky.bhajun@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 as well as in its 2017 annual financial report
filed with the French Financial Markets Authority on March 29, 2018
(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.
Forward-looking statements speak only as of the date of this
release, and Nanobiotix undertakes no obligation to update or
revise these statements, except as may be required by law.
- NBTX-PR_ImmunoRad_VF_20092018
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