NANOBIOTIX ANNOUNCES FIRST EVER
RADIOENHANCER TO RECEIVE EUROPEAN MARKET APPROVAL
- Hensify®(NBTXR3) received European market approval (CE mark)
enabling commercialization in 27 European Union countries for the
treatment of locally advanced soft tissue sarcoma
- Hensify®--a first-in-class radioenhancer--offers cancer
patients an innovative treatment with a broadly applicable
mechanism of action
- After positive phase II/III data, this approval represents
significant step forward in establishing NBTXR3 as a major oncology
treatment
Laurent Levy, CEO of Nanobiotix, commented, “We
could not be more proud to receive market approval in Europe for
Hensify®. This approval validates more than 15 years of hard work,
cutting edge science, and a fierce commitment to changing the lives
of patients. This is a significant achievement and represents just
one more step in our mission to improve life for millions of people
around the world.”
Paris, France, and Cambridge,
Massachusetts (USA) April 4, 2019 – NANOBIOTIX
(Euronext : NANO – ISIN : FR0011341205), a clinical-stage
nanomedicine company pioneering new approaches in the treatment of
cancer, announced today that Hensify® (NBTXR3) has obtained a CE
mark for the treatment of locally-advanced soft tissue sarcoma
(“STS”). Hensify® is the brand name for NBTXR3 as approved
for the treatment of locally-advanced STS.
Hensify® is a first-in-class product introducing
a new, physical mechanism of action. This innovative product was
designed by Nanobiotix to physically destroy tumors and activate
the immune system for both local control and systemic disease
treatment when combined with radiation therapy. In addition to
Hensify®, NBTXR3 is currently under evaluation in various other
indications such as lung cancer, head and neck cancers, liver
cancer, and prostate cancer.
Hensify® is an aqueous suspension of crystalline
hafnium oxide (HfO2) nanoparticles designed for injection directly
into a tumor prior to a patient’s first standard radiotherapy
treatment. When exposed to ionizing radiation, Hensify® amplifies
the localized, intratumor killing effect of that radiation. The
dose of X-ray delivered to the tumor is magnified, whilst the dose
passing through healthy tissues remains unchanged. Hensify®
requires a single administration and will fit into current
worldwide standards of radiation care.
STSs are rare cancers that develop in different
types of soft tissues including fat, muscles, joint structures and
blood vessels. Radiotherapy followed by surgery is part of the
typical treatment regimen for STS patients in Europe. The
Act.In.Sarc phase II/III trial was a prospective, randomized (1:1),
multinational, open label and active controlled two armed trial of
180 adult patients with locally advanced STS of the extremity or
trunk wall. The objective of the trial was to evaluate the
pre-operative efficacy and the safety of Hensify® activated by
radiotherapy compared to the standard of care (radiotherapy
alone).
The positive Act.In.Sarc study results were
presented at the 2018 ASTRO and ESMO Annual Congresses. The trial
achieved its primary endpoint with a pathological complete response
(<5% viable cancer cells) rate of 16.1% in the Hensify® arm
compared to 7.9% in the control arm (p=0.0448). In addition, in the
subgroup of patients with a more aggressive disease (histologic
grade 2 and 3), a pathological complete response was achieved in
four times as many patients in the Hensify® arm as in the control
arm (17.1% compared 3.9%).
Similar safety profiles were observed in the
Hensify® arm and the radiation therapy alone control arm. Hensify®
did not impair the patients’ ability to receive the planned dose of
radiotherapy and the radiotherapy safety profile was similar in
both arms, including the rate of postsurgical wound complications.
Hensify® was associated with grade 3-4 acute immune reactions which
were manageable and of short duration. Further, Hensify® showed a
good local tolerance in the trial and did not have any impact on
the severity or incidence of radiotherapy-related adverse
events.
Post-approval trials are planned across Europe
and discussions on next steps regarding potential further
development are ongoing.
***
About Hensify® (NBTXR3)
NBTXR3 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 first radiotherapy treatment
session, and has the ability to fit into current worldwide
standards of radiation care. The physical mode of action of
NBTXR3 makes it applicable across solid tumors such as lung,
prostate, liver, glioblastoma, and breast cancers.
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 unable to receive
chemotherapy or cetuximab with very limited therapeutic options.
Promising results have been observed in the phase I/II trial
regarding the local control of the tumors. In the United States,
based on the discussions with the Food and Drug Administration that
occurred in the first half of 2019, the Company plans to begin the
clinical trial authorization process in the second half of 2019 and
commence a phase II/III clinical trial in locally advanced head and
neck cancers.
Nanobiotix is also running an Immuno-Oncology development
program. In the United States, the Company received approval from
the Food and Drug Administration to launch a clinical trial of
NBTXR3 activated by radiotherapy in combination with anti-PD-1
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.
Further, the company has a large-scale, comprehensive clinical
research collaboration with The University of Texas MD Anderson
Cancer Center (9 new phase I/II clinical trials in the United
States) to evaluate NBTXR3 across head and neck, pancreatic,
thoracic, lung, gastrointestinal and genitourinary cancers.
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, including the development and commercialization
of Hensify®. 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.
- PR_Nanobiotix_marquage_CE_V04042019_VF
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