NANOBIOTIX ANNOUNCES PUBLICATION OF PHASE
III SOFT TISSUE SARCOMA DATA FOR FIRST-IN-CLASS NBTXR3 IN THE
LANCET ONCOLOGY
- Previously reported data from the registration study
(Act.In.Sarc) in advanced Soft Tissue Sarcoma (STS) patients
demonstrated a significant advantage in both pathological complete
response (pCR) and rate of margin-negative resection (R0) for those
treated with NBTXR3 activated by standard of care radiation therapy
(RT) versus RT alone
- Data showed that an increase in efficacy was achieved
with the addition of NBTXR3 without a significant difference in the
safety profile compared to RT alone
- The trial validates the clinical application of the
mode of action of this new class of treatment, which supports
further investigation in a larger field of
indications
“Act.In.Sarc results published in The Lancet
Oncology show clear superiority of NBTXR3 activated by radiation
therapy versus radiation alone as evidenced by the significant
increase in complete response. As I have stated previously, NBTXR3
is an innovation that could bring real benefits to patients and
change the standard of care. It is an honor to have this potential
recognized by our scientific peers.” – Pr. Sylvie Bonvalot, MD,
PhD, Head of Sarcoma and Complex Tumor Surgery at the Curie
Institute and Global Principal Investigator of the Act.In.Sarc
Study.
“The data published in The Lancet Oncology
represent another important moment for our company, our partners,
and our patients. As members of the global scientific community we
have a responsibility to make positive and substantial
contributions to our field. Achievement of first European market
approval provided validation for our contribution from a regulatory
perspective, but recognition from our peers is especially
rewarding.” – Edwina Baskin-Bey, MD, Chief Medical Officer of
Nanobiotix.
Paris, France and Cambridge,
Massachusetts, USA, July 9, 2019 –
NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a clinical-stage
nanomedicine company pioneering new approaches to the treatment of
cancer, today announced that the previously reported results from
the Phase II/III Act.In.Sarc trial evaluating NBTXR3 in patients
with advanced STS have been published online in The Lancet
Oncology.
The registration study met its primary (pCR) and
secondary (R0 rate) endpoints. The increased proportion of patients
with pCR among those given NBTXR3 as a single injection prior to
standard of care RT when compared to RT alone (approximately twice
as many), provides robust justification for the efficacy of
nanoparticle-enhanced tumor cell death. The overall safety profile
of NBTXR3 activated by RT was similar to RT alone, with manageable
and reversible transient immune reactions observed in those treated
with NBTXR3 and RT. More detail on the results can be found
here.
The data from the Act.In Sarc trial were the
basis for first European market approval (CE marking) of NBTXR3 in
advanced STS of the extremity and chest wall, under the brand name
Hensify®. With STS results validating the efficacy and safety
profile of the product, the company will continue its development
strategy to evaluate NBTXR3 in multiple global (US, EU and APAC)
clinical trials with a focus including but not limited to: head and
neck, liver, lung and prostate cancer, as well as tumors that may
benefit from NBTXR3 in combination with immune-oncology agents.
-Ends-
About Phase II/III Act.In.Sarc
Study
Nanobiotix and its partner, PharmaEngine treated
179 patients in 32 sites across 11 countries in Europe and Asia.
The Global Principal Investigator is Pr. Sylvie Bonvalot, MD, PhD
(Institut Curie, Paris, France).
Primary Endpoint
Pathological Complete Response Rate (pCR): A
pathological complete response is defined as the presence of less
than 5% of residual malignant viable cells in the surgically
removed tissue. The primary endpoint compared the proportion of
patients with pCR between the two randomized arms. This was
determined by an independent pathological central review according
to Wardelmann et al., 2016.
Key Secondary Endpoint
Resection Margin Status: The resection margin
status is evaluating the quality of surgery. Surgery remains the
mainstay of care for advanced soft tissue sarcoma. The primary
surgical objective is the complete removal of the tumor with
negative resection margins (R0). Several retrospective studies
suggest that surgical margin status predicts the risk of local and
distant recurrence. In particular, negative surgical margins are
significantly correlated to increased patients’ survival.
About NBTXR3NBTXR3 is a
first-in-class product designed to destroy tumors through physical
cell death when activated by radiotherapy.
NBTXR3 has a high degree of biocompatibility,
requires one single administration before the first radiotherapy
treatmentsession, and has the ability to fit into current worldwide
standards of radiation care. The physical mode of action of
NBTXR3makes 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 ororopharynx 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 tobegin the clinical trial authorization process in the
second half of 2019 and commence a phase II/III clinical trial in
locallyadvanced head and neck cancers.
Nanobiotix is also running an Immuno-Oncology
development program. In the United States, the Company received
approvalfrom the Food and Drug Administration to launch a clinical
trial of NBTXR3 activated by radiotherapy in combination with
antiPD-1 antibodies in lung, and head and neck cancer patients
(head and neck squamous cell carcinoma and non-small cell
lungcancer).
The other ongoing NBTXR3 trials are treating
patients with liver cancers (hepatocellular carcinoma and liver
metastasis), locallyadvanced or unresectable rectal cancer in
combination with chemotherapy, head and neck cancer in combination
withconcurrent chemotherapy, and prostate adenocarcinoma.Further,
the company has a large-scale, comprehensive clinical research
collaboration with The University of Texas MDAnderson 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)
241-4400investors@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,
including its prospects and product candidate development. 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
registered with the French Financial Markets Authority (Autorité
des Marchés Financiers) under number R.19-018 on April 30, 2019 (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.
- 20190709_TheLancetOncologypublication
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