Nanobiotix provides update on the global development of its lead product NBTXR3
- Nanobiotix will give two immuno-oncology presentations at the Society for Immunotherapy of Cancer (SITC) conference this month
- Tolerability, safety and first tumor response data in liver cancer will be presented at the ASCO GI conference in January 2018
- IND application in process of being filed in the U.S. for a combination trial with checkpoint inhibitors
Paris, France and Cambridge, Massachusetts, USA, November 9, 2017 - NANOBIOTIX (Euronext: NANO - ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, today provides an update on the global development of its lead product, NBTXR3.
Nanobiotix's lead product, NBTXR3, has a universal physical mode of action which is designed for the local destruction of tumors. In addition to the physical destruction of cancer cells, recently published data suggests that NBTXR3 generates immunogenic cell death that could trigger a specific immune response to attack tumors. In this regard, Nanobiotix is developing several programs in Immuno-Oncology on top of its core developments.
The global development of NBTXR3 is progressing well, following the Company's expectations.
Status of ongoing clinical trials
|NBTXR3 USAGE||INDICATION||PHASE||STATUS||NEXT STEP|
|Single Agent||Head and Neck Cancer |
(Radiotherapy alone in elderly patients)
| Phase I/II |
| Recruiting |
Safety and feasibility established
|Interim update on expansion cohort - mid-2018|
|Liver Cancers |
(HCC & Metastasis)
| Phase I/II |
| Recruiting ||First set of trial data (primary & Liver Mets) - January 2018|
|Soft Tissue Sarcoma |
| Phase II/III |
EU, Asia-Pacific, South Africa
| End of recruitment ||Presentation of results - H1 2018|
|Rectum Cancer || Phase I/II |
| Recruiting ||PharmaEngine calendar|
|Prostate Cancer|| Phase I/II |
| Recruiting ||2018|
|Combinations||Head and Neck Cancer |
(Radiotherapy + Chemotherapy)
| Phase I/II |
| Recruiting ||PharmaEngine calendar|
|Head and Neck & Lung Cancers + checkpoint inhibitors|| Phase I |
|IND application in process||IND approval - H1 2018|
NBTXR3 in Head and Neck Cancer, Phase I/II trial, in elderly patients (Europe)
Prof. Christophe Le Tourneau, the trial's Principal Investigator, presented an update during the Trends in Head and Neck Oncology conference (THNO) earlier this month. This update included a median follow up of 14.2 months, confirming the potential impact of NBTXR3 on the long-term response of the treatment.
Following the very positive results obtained, Nanobiotix filed a protocol amendment of this study to include 44 additional patients - an expansion which aims to demonstrate the efficacy of NBTXR3. Nanobiotix is also opening 12-15 additional sites in Europe to expand the development of this indication.
NBTXR3 Immuno-Oncology clinical and preclinical programs
The Society for Immunotherapy of Cancer (SITC) conference has invited Nanobiotix to present an update of its Immuno-Oncology program on Soft Tissue Sarcoma (STS) patient data on November 11, 2017. During this conference, the Company will also provide preclinical Immuno-Oncological data on November 12, 2017.
NBTXR3 in Liver Cancers, Phase I/II trial (France)
Nanobiotix has been selected to present at the ASCO GI conference, the world's leading gastrointestinal oncology symposium, on January 18-20, 2018. The Company plans to present the safety and tolerability results and the first tumor response of patients treated at the first dose levels, and detail the next steps of the trial.
NBTXR3 in Combination with Checkpoint Inhibitors in Lung and Head and Neck Cancer patients (U.S.) - Immuno-Oncology program
Nanobiotix plans to conduct its first clinical trial with NBTXR3 in combination with immune checkpoint inhibitors in the U.S., with a multi-arm trial targeting a sub-population of advanced lung, and head and neck cancer patients. The medium-term objective is to transform non-responders into checkpoint inhibitor responders while improving patient benefits. The trial aims to evaluate the ability of NBTXR3 to generate an abscopal effect.
This trial also aims to expand the potential of NBTXR3, including using it to treat recurrent or metastatic disease.
The trial would begin by combining NBTXR3 with any approved checkpoint inhibitors in head and neck squamous cell carcinoma or non-small cell lung cancer.
The IND application for this trial is ongoing.
NBTXR3 - CE Marking
Nanobiotix is working closely with the notified body in order to prepare for the CE Marking. The process is progressing according to plan and the Company's original time horizon remains unchanged.
About NANOBIOTIX: www.nanobiotix.com
Nanobiotix (Euronext: NANO / ISIN: FR0011341205) is a late clinical-stage nanomedicine company pioneering novel approaches for 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 filed in August 2016 for market approval (CE Marking) in Europe for its lead product NBTXR3.
In 2016 the Company started a new preclinical research program 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 is based in Paris, France, with a U.S. affiliate in Cambridge, MA.
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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 reference document of Nanobiotix filed with the French Financial Markets Authority (Autorité des Marchés Financiers) under number D.17-0470 on April 28, 2017 (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. 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.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: NANOBIOTIX via Globenewswire