Nanobiotix: 2017 review and 2018 expected
milestones
Paris, France and Cambridge, Massachusetts,
USA, December 26, 2017 - NANOBIOTIX (Euronext: NANO - ISIN:
FR0011341205), a late clinical-stage nanomedicine company
pioneering novel approaches for the local treatment of cancer,
today provides a recap of its activities and achievements in 2017
and an overview of its anticipated 2018 milestones.
- Strong news flow anticipated for 2018
- Acceleration and expansion of clinical development
- First data showing strong potential of NBTXR3 lead product in
high risk elderly H&N patients
- Progress in first European market approval but notified body
requests more time to finalize technical evaluation
- Completion of recruitment of Soft Tissue Sarcoma PII/III
- Structuration of company to become a fully integrated pharma
company
- €52M raised with two private placements
- From first data in new immuno-oncology program to FDA approval
to start a first clinical trial combining NBTXR3 and anti-PD1
antibody
I - 2017 Review
Regulatory and premarket activities
- CE mark progress, December update
Nanobiotix,
in accordance with the notified body for medical devices
(LNE/G-MED), has followed a pathway for CE marking that involves
two steps within Annex II: The conformity of the full quality
assurance system and the product technical file.
As part of the Annex II process, LNE/G-MED
audited Nanobiotix in October 2017 regarding the design,
development, manufacturing and commercialization of the product. No
major findings were identified by the auditors, which presumably
puts the Company in a good position to obtain Annex II.
Regarding the technical file, LNE/G-MED recently
informed us they would need a few more months to finalize the
evaluation required for CE marking.
- Medical Affairs activities
Nanobiotix
establihed in the second half of 2017 a strong international team
of experienced medical science liaison officers to support the
dissemination of knowledge and the use of NBTXR3 within the
international medical community prior to approval. To support these
developments, Nanobiotix recently opened two new affiliates in
Europe, in Germany and in Spain.
- Nanobiotix opens new manufacturing facility
In
November 2017, Nanobiotix expanded its manufacturing capabilities
to increase its production capacities for the commercial launch and
clinical trials needs. This new facility is located in the
Villejuif BioPark, a scientific research and innovation center just
outside of Paris, France. The new facility will supplement the
existing capacities.
NBTXR3's development
- Soft Tissue Sarcoma (STS) Phase II/III, "Act.In.Sarc"
pivotal trial (www.actinsarc.com)
March 2017, positive interim analysis:
pre-planned interim analysis was based on the results of two-thirds
of the patients included - 104 out of a total of 156 patients were
analyzed. Based on the available safety and efficacy data, the
Independent Data Monitoring Committee recommended the continuation
of the ongoing Phase II/III trial of NBTXR3 in soft tissue
sarcoma.
October 2017: Nanobiotix completed
patient inclusion for the Phase II/III trial. The Company expects
to present the results of this trial in Q2 2018.
- Phase I/II head and neck trial in high risk elderly
patients
June 2017: Nanobiotix presented first
results from its Phase I/II head and neck cancer trial with NBTXR3
at the American Society of Clinical Oncology's (ASCO) annual
meeting.
Good safety and promising signs of efficacy
and long-term control: The results showed a very good safety
profile for NBTXR3 with no Adverse Events (AEs) and no Serious
Adverse Events (SAEs) in frail elderly patients with stage III/IV
cancer, seven out of nine patients achieved a Complete Response at
a 10% dose level or more. Patient follow-up showed a potential
impact on long-term disease control.
July 2017, in light of the promising
results, Nanobiotix filed a protocol amendment to include 44
additional patients. Up to 15 additional sites in Europe would be
added for this expansion phase.
November 2017 Prof. Christophe Le
Tourneau, the trial's Principal Investigator, presented an update
during the Trends in Head and Neck Oncology conference (THNO), with
a patient median follow up of 14.2 months, confirming the potential
impact of NBTXR3 on the long-term response of the
treatment.
Preclinical data presented at three major
international conferences in 2017 demonstrating that
NBTXR3 activated by radiotherapy could generate an adaptive
antitumor immune response, turning "cold" tumors in "hot"
tumors:
- American Association for Cancer Research (AACR) Annual Meeting
2017, Washington D.C
- "Immunotherapy workshop - Incorporating Radiation Oncology into
Immunotherapy" co-sponsored by the American Society of Radiation
Oncology (ASTRO), the National Cancer Institute (NCI) and the
Society for Immunotherapy of Cancer (SITC), Bethesda
- Society for Immunotherapy of Cancer (SITC) Annual Meeting,
National Harbor
November 2017, first human data presented at
SITC showing that NBTXR3 could transform a cold tumor into a
hot tumor in Soft Tissue Sarcoma. In November, Nanobiotix
presented new clinical data confirming NBTXR3's significant
potential role in immuno-oncology at the Society for Immunotherapy
of Cancer (SITC) Annual Meeting.
These data showed the potential of NBTXR3 to
transform "cold" tumors into "hot" tumors. They showed that NBTXR3
activated by radiotherapy induces a different and significant
adaptive immune pattern versus radiotherapy in patients with soft
tissue sarcoma.
These clinical and preclinical data indicate
that NBTXR3 could play a key role in immuno-oncology.
- December 2017: FDA approved Nanobiotix' IND application for
a study of NBTXR3 activated by Radiotherapy in combination with
anti-PD1 antibody in lung, and head and neck cancer
patients
Nanobiotix will start in Q2 2018 a new phase
I/II clinical trial with NBTXR3 activated by radiotherapy in
combination with anti-PD1 antibody in the U.S. The multi-arm trial
will include locoregional recurrent and/or metastatic lung, and
head and neck cancer patients that are either anti-PD1 naïve or non
responders at 12 weeks. The phase II portion of the trial will
investigate the potential of NBTXR3 to transform anti-PD1
non-responders into responders and increase responses of anti-PD1
antibody in locoregional recurrent HNSCC amenable to
re-irradiation.
Corporate and financial events
- Nanobiotix appointed senior executive from pharmaceutical
industry, as Chief Operating Officer
At the beginning of 2017, Nanobiotix appointed
Alain Dostie, an oncology industry veteran from the pharmaceutical
industry, as Chief Operating Officer to oversee NBTXR3 product
development and commercialization.
- €52M raised with two private placements
Nanobiotix
realized two private placements in order to support the
acceleration and the expansion of the development and
commercialization plan and to expend its financial visibility.
These operations opened the opportunity for Nanobiotix to welcome
new European and U.S. qualified biotech investors. The cumulated
amount of money raised is about €52.3 M.
II - 2018 Forthcoming news flow: selected
milestones
2018 should be another year of growth for
Nanobiotix with multiple new and ongoing projects!
- First presentation of liver Phase I/II trial data (primary
and metastasis) to be presented at ASCO-GI
- First patient recruitment in Phase I/II clinical trial in
the US looking at the potential of NBTXR3 to transform anti-PD1 non
responders into responders. The multi-arm trial will include
recurrent and/or metastatic lung, and head & neck cancer
patients
- Presentation of the results of Phase II/III STS, after last
patient has been treated and the analysis is complete
- First market approval in Europe, CE marking
- Interim update from Phase I/II head and neck cancer trial
with high risk elderly patients
- Additional news on other clinical trials and
programs
***
About NBTXR3
NBTXR3 is an injectable aqueous suspension of
hafnium oxide nanoparticles designed as an innovative therapeutic
agent for the treatment of solid tumors, currently in clinical
development by Nanobiotix.
Once injected intratumorally, NBTXR3 can deposit
high energy within tumors only when activated by an ionizing
radiation source, notably radiotherapy. Upon activation, the high
energy radiation is physically designed to kill the tumor cells by
triggering DNA damage and cell destruction and improve clinical
outcomes.
Promising results indicate that NBTXR3 activity
could be applicable across solid tumors triggering immunogenic cell
death, leading to an immune response, reinforcing a local and
potentially systemic effect, and contributing to transform "cold"
tumors into "hot" tumors. NBTXR3's major characteristics are
represented by a high degree of biocompatibility, one single
administration before and during the whole therapy and the ability
to fit into current standards of radiotherapy care.
NBTXR3 entered clinical development in 2011 in a
Phase I/II with patients suffering from advanced soft tissue
sarcoma of the extremities and is currently in the final stages of
its subsequent phase II/III. In parallel, it is currently being
tested in numerous Phase I/II clinical trials with patients
suffering from locally advanced squamous cell carcinoma of the oral
cavity or oropharynx (head and neck), liver cancer (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.
About NANOBIOTIX: www.nanobiotix.com
Nanobiotix (Euronext: NANO / ISIN: FR0011341205)
is a late clinical-stage nanomedicine company pioneering novel
approaches to the treatment of cancer. The Company's
first-in-class, proprietary technology, NanoXray, enhances
radiotherapy energy with a view to providing 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 is also running research programs in
immuno-oncology, with its lead product NBTXR3, which could have the
potential to bring a new dimension to cancer immunotherapies.
Nanobiotix is listed on the regulated market of
Euronext in Paris (ISIN: FR0011341205, Euronext ticker: NANO,
Bloomberg: NANO: FP). The Company's Headquarters are based in
Paris, France, with a U.S. affiliate in Cambridge, MA.
Contact
Nanobiotix |
Sarah GaubertDirector, Communications & 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 |
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 |
|
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 update of the
reference document of Nanobiotix filed with the French Financial
Markets Authority (Autorité des Marchés Financiers) under number
D.16-0732-A01 on December 27, 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
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.
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