Nanobiotix: 2016 review and 2017
anticipated milestones
Paris, France and Cambridge, Massachusetts,
USA, January 31, 2017 - NANOBIOTIX (Euronext: NANO - ISIN:
FR0011341205), a late clinical-stage nanomedicine company
pioneering novel approaches for the local treatment of cancer,
today provides its activities and achievements during 2016 and an
overview of anticipated 2017 milestones.
- 2016 Review
2016: NBTXR3 clinical development
- The Soft Tissue Sarcoma (STS) PII/III trial has progressed well
(one trial through Europe and Asia)
This indication is the most advanced in
Nanobiotix's pipeline. The "Act.In.Sarc" pivotal trial
(www.actinsarc.com), is currently ongoing in 13 countries through
Europe and Asia (via PharmaEngine).
In November, Nanobiotix announced that the
target of 104 patients (2/3 of patients) needed for the interim
readout was reached, with 115 patients randomized and 153 having
signed the inform consent out of the total of 156 STS evaluable
patients expected in this trial.
- Head and Neck cancer positive interim results in European PI/II
trial and launch of a new PI/II trial in Asia
The Company reported preliminary positive
results from phase I/II trial (treated with radiotherapy alone plus
NBTXR3) in July. Safety and feasibility have been achieved at the
first 3 dose levels and data has shown preliminary positive signs
of antitumoral effect in all evaluable patients.
PharmaEngine, Nanobiotix's partner for the
Asia-Pacific area, has launched a new clinical trial in October in
head and neck cancer patients treated with radiotherapy and NBTXR3
plus chemotherapy. This is the seventh clinical trial with
NBTXR3.
- Prostate cancer trial launch in the U.S.
Nanobiotix announced that the US Food and Drug
Administration (FDA) has approved the first Company's
Investigational New Drug (IND) application, allowing the Company to
launch its first Phase I/II prostate cancer trial in the US.
The recruitment of patients has started at
Ronald Reagan UCLA Medical Center, Los Angeles CA. Two other
centers are involved: Thomas Jefferson University Hospital PA,
Philadelphia and Dana Farber Cancer Institute, Boston MA.
- Liver cancers (HCC & met) PI/II trial in Europe, positive
preliminary results
In December Nanobiotix released positive results
from phase I/II trial. Preliminary data shown feasibility and good
safety of treatment with NBTXR3 in liver cancers at 10% dose
level.
2016: NBTXR3 first filing for market
authorization in
Europe According
to plan, the Company filed for certification of NBTXR3 in August
2016 based on the level of clinical and scientific evidence
available at that time. LNE/G-MED, the French notified body, has
given guidance that the review of results for a potential CE mark
could be expected in 2017.
2016: Opening a new application in
immuno-oncology for lead product NBTXR3
Expansion into immuno-oncology, preclinical
results: Proof of Concept (POC)After 11 months of development, the
Company presented preclinical data at the annual meeting of the
Society for Immunotherapy of Cancer (SITC), demonstrating that
NBTXR3 actively stimulates the host immune system to attack tumor
cells. Study results suggest NBTXR3's potential to transform the
tumor into an in-situ vaccine.
On top of the Company's core development
activities, these findings could open new collaborations for NBTXR3
through combinations with other immuno-oncology drugs.
2016: Corporate & financial
events
- U.S. reinforcement of the management
Nanobiotix strengthened its U.S. leadership team
with the appointments of Dr. Mihail Obrocea as the Head of U.S.
Clinical Development and Noel Kurdi as the Director of Investor
Relations. These additions contribute to the strengthening of the
Company's clinical development and leverage U.S. investors'
potential, to continue the growth of the Company.
- € 21.3M private placement
Completion of a private placement of EUR 21.3
million. The investor base consisted primarily of life sciences
specialists, the majority of which were from the United States.
- US $1M milestone payment from Taiwan-based partner
PharmaEngine
The USD 1m payment from PharmaEngine has been
triggered by the injection of the first patient undergoing
treatment in Nanobiotix' Soft Tissue Sarcoma (STS) pivotal phase in
Asia.
- € 2M Grant from Bpifrance
In September, Bpifrance has awarded the Company
an interest-free loan of €2M for Innovation (Prêt à Taux Zéro pour
l'Innovation - PTZI).
- 2017 Forthcoming news flow: pivotal
milestones
This
year the Company could receive its first market approval with
NBTXR3 (CE Mark), which would open access to the product for cancer
patients.
In parallel, the ongoing clinical trials with
NBTXR3 in seven indications will deliver several read-outs this
year.
The Company is also expanding its exciting
developments in Immuno - Oncology (IO), broadening the potential
value of NBTXR3 with new applications for the product.
2017 should be full of remarkable events,
enhancing Nanobiotix medical and scientific value and bringing
Nanobiotix to the next level.
NBTXR3 to market
- Interim readout STS PII/III trial and commercialization
plan
Nanobiotix is expecting the analysis by an
independent committee of interim STS Phase II/III results, to
determine whether if the continuation of the trial is possible.
Nanobiotix plans to release the conclusion of this analysis around
spring 2017.
The independent committee of experts, will (i)
review the data related to the primary endpoint (Complete
Pathological Response Rate), (ii) ensure the safety of all patients
enrolled in the study, (iii) evaluate the quality of the data
collected, and (iv) assess the continued scientific validity of the
study design. This analysis will be performed on two third of the
treated patients (104 patients).
Assuming positive outcomes from the interim
Phase II/III data readout, the Company will thereafter communicate
its overall plan for the European commercialization of NBTXR3.
- 1st European market authorization expected in 2017
Nanobiotix anticipate that it may receive its
first market authorization in 2017. This approval would allow
Nanobiotix to start diffusing its product in European market.
Following the CE marking and availability of the complete data of
the Phase II/III (act.in.sarc study), the Company will commence
negotiations in different countries to seek product
reimbursement.
NBTXR3 clinical expansion
Nanobiotix continues its clinical expansion and
expects to release data this year, increasing NBTXR3's value.
- Head and Neck cancer, PI/II data presentation and plan for next
steps
In the second half of 2017 the Company aims to
present complete data from the Phase I/II trial.
This indication holds great potential, and the
Company will issue this year the clinical development plan of this
indication, that could potentially take place in EU and in the
U.S.
- Prostate cancer, preliminary PI/II data
The first trial launched in the U.S. in 2016
should deliver this year (H2 2017) preliminary PI/II data on safety
and feasibility.
- Liver metastasis and primary liver cancer: completion of Phase
I recruitment, population selection for Phase II
By the end of 2017, Nanobiotix should complete
patients' recruitment of the phase I part, and may proceed to the
selection of patient population for the dose-expansion part of the
trial.
Immuno Oncology (IO) developments
In parallel to its core developments, Nanobiotix
will continue developing its Immuno-Oncology program and present
new results in 2017.
This program could lead at medium term to new
potential collaborations with pharma companies developing
immuno-oncology drugs.
The abovementioned information are detailed in
the press releases previously issued by the Company and available
on its website: http://www.nanobiotix.com/_en/news/
- 2017 Financial calendar
Nanobiotix will announce its financial and
operating results according to the following indicative
calendar:
- February 28, 2017 - Revenue for Q4 2016
- April 28, 2017 - 2016 Annual results
- May 15, 2017 - Revenue for Q1
- June 14, 2017 - Annual General Meeting Paris, France
- July 12, 2017 - Revenue for Q2
- August 31, 2017 - Half year results
- November 15, 2017 - Revenue for Q3
...
About NANOBIOTIX: www.nanobiotix.com
Nanobiotix (Euronext: NANO / ISIN: FR0011341205)
is a late clinical-stage nanomedicine company pioneering novel
approaches for the local treatment of cancer. The Company's
first-in-class, proprietary technology, NanoXray, enhances
radiotherapy energy with a view to provide 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 has filed in August 2016 for market approval (CE Marking)
in Europe for its lead product NBTXR3.
Nanobiotix is listed on the regulated market of
Euronext in Paris (ISIN: FR0011341205, Euronext ticker: NANO,
Bloomberg: NANO: FP). The Company Headquarter is based in Paris,
France. Affiliate in Cambridge, United States.
Contact
Nanobiotix |
Sarah GaubertHead of Communication and 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 -
The Ruth Group Kirsten Thomas +1 508-280-6592
Nanobiotix@theruthgroup.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 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.
NBTXR3 is currently under development in
clinical studies with the purpose of obtaining a CE mark in the
future. 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.
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