Bli medlem
Bli medlem

Du är här

2017-01-31

NANOBIOTIX : 2016 review and 2017 anticipated milestones

----
| |
| |
----
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.

1 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 anin-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 paymentfrom 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.

* € 2MGrant fromBpifrance

In September, Bpifrance has awarded the Company an interest-free loan of €2M
for Innovation (Prêt à Taux Zéro pour l'Innovation - PTZI).

1 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/

1 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 Gaubert Noël Kurdi |
| |
|Head of Communication and Public Affairs Director, Investor Relations |
|+33 (0)1 40 26 07 55 +1 (646) 241-4400 |
|sarah.gaubert@nanobiotix.com/ noel.kurdi@nanobiotix.com/investors@nanobiotix.com |
| |
|contact@nanobiotix.com |
| Media relations ...

Författare Hugin

Tala om vad ni tycker

Tala om vad ni tycker

Ni är just nu inne på en betaversion av nya aktiespararna. Lämna gärna feedback på vad ni tycker i formuläret nedan.