Nanobiotix announces its clinical registration plan in Head and Neck cancers for the United States following FDA feedback
26 Mars 2019 - 8:00AM
- Moving forward with Overall Survival (OS)-based,
randomized, event-driven clinical trial for the United
States
- Pre-IND feedback from US Food and Drug Administration
(FDA) provides clarity to Nanobiotix on US regulatory pathway to
approval
- Clinical trial authorization process to begin in 2H2019
with FDA filing
‘‘We are happy to announce our plan for the
registration pathway in Head and Neck cancers in the US. This is a
key milestone for the Company and our shareholders, and we look
forward to critical next steps toward US development,’’ commented
Laurent Levy, Nanobiotix’s CEO.
Paris, France; Cambridge, Massachusetts
(USA); March 26, 2019 - NANOBIOTIX
(Euronext: NANO – ISIN: FR0011341205 – the
‘‘Company’’), a clinical-stage
nanomedicine company pioneering new approaches to the treatment of
cancer, today announced that the Company has clarity on its
regulatory pathway in the treatment of Head and Neck cancers for
first-in-class radioenhancer NBTXR3. The announcement follows
pre-IND feedback from the US FDA received on March 18,
2019.
Stage III and IV Head and Neck cancers include
large primary tumors which may invade underlying structures and/or
spread to regional nodes. Treatment of these locally advanced
forms of the disease—which makes up more than 50% of all Head and
Neck cancers—requires aggressive, concerted measures that often
remain a clinical challenge with an estimated 5-year survival rate
of 50% with the current standard of care.
Within the Stage III and IV Head and Neck
cancers patient population, the Company targets a subpopulation of
patients, who have a higher risk of recurrence, or a poorer
prognosis as they have an inability to receive cisplatin, the
frontline chemotherapy drug for advanced Head and Neck cancers.
Additionally, the localization of the tumor focuses on oropharynx,
hypopharynx, and oral cavity – representing the majority of Head
and Neck cancers.
Based on US FDA feedback, the Company plans to
design an Overall Survival (OS)-based, randomized, event-driven
Phase II/III clinical trial. 50% of patients will receive standard
of care radiotherapy combined with NBTXR3 while the other 50% will
receive radiotherapy in combination with cetuximab. The expected
total number of patients to participate in this global clinical
trial is approximately 600, and an efficacy interim analysis is
planned.
Notably, the US FDA has not objected to the use
of the data from the dose-escalation phase of the Company’s
European Phase I clinical trial in elderly and frail patients with
locally advanced Head and Neck cancers as well as the Company’s
current CMC (chemical, manufacturing and control) development
plan.The Company plans to initiate its global clinical trial
authorization process with US FDA in 2H2019.
-Ends-
About NBTXR3
NBTXR3 is a first-in-class product candidate
designed to destroy tumors and metastasis when activated by
radiotherapy.
NBTXR3 has a high degree of biocompatibility and
requires one single administration before the whole radiotherapy
treatment. Nanobiotix believes NBTXR3 has the ability to fit into
current worldwide standards of radiation care.
Nanobiotix’s broad clinical program includes 7
clinical trials. In June 2018, Nanobiotix established human proof
of concept for this first-in-class product candidate in its Soft
Tissue Sarcoma (STS) Phase III clinical trial.
NBTXR3 is actively being studied in head and
neck cancer with locally advanced squamous cell carcinoma of the
oral cavity or oropharynx in elderly and frail patients who are
unable to receive chemotherapy or cetuximab and have very limited
therapeutic options. Promising results from these clinical studies
have been observed from the ongoing Phase I/II trial regarding the
local control of tumors.
Nanobiotix is also running an Immuno-Oncology
development program. In the United States, Nanobiotix has received
approval from the US FDA 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 trials 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 STS indication.
About
NANOBIOTIX: www.nanobiotix.com
Incorporated in 2003, Nanobiotix is a leading,
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 rooted in designing
pioneering, physical-based approaches to bring highly effective and
generalized solutions to address unmet medical needs and
challenges.
Nanobiotix’s first-in-class, proprietary lead
technology, NBTXR3, aims to expand radiotherapy benefits for
millions of cancer patients. 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 in Paris, France, with a
U.S. affiliate in Cambridge, MA, and European affiliates in Spain
and Germany.
Contacts
Nanobiotix |
|
Communications Department+33 (0)1 40 26 07 55+1
(617) 852-4835contact@nanobiotix.com |
Investor Relations
Department +33 (0)1 79 97 29 99+1 (646) 241-4400
investors@nanobiotix.com |
|
Media Relations |
|
France -
Springbok ConsultantsMarina
Rosoff+33 (0)6 71 58 00 34marina@springbok.fr |
|
US –
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
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.
- 2019_Nanobiotix_HN_clinical_registration_plan_US_26032019
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