Study of biomarkers in 26 patients with Soft Tissue Sarcoma (study arm comparator)
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Data showing an antitumor immune response adaptive triggered by the treatment with NBTXR3
Opening of potential synergies with the approaches to Immuno-Oncology, including checkpoint
Paris, France, and Cambridge, Massachusetts (USA) may 18, 2017 NANOBIOTIX (Euronext : NANO ISIN: FR0011341205), a French company pioneer in nanomedicine in developing new therapeutic approaches for the treatment of cancer, today announced the first in a series of clinical data from its program in Immuno-Oncology (IO), showing that the product NBTXR3 could potentially transform the tumors “cold” tumors ” hot “.
Laurent Levy, CEO of Nanobiotix, commented: “The ability to transform tumors cold in tumors hot is one of the most important issues of oncology. Our early clinical data suggest that NBTXR3 could play a major role in the world of Immuno-Oncology. Given its mode of action physical universal and its good safety profile in the long term, NBTXR3, may change in the treatment of many cancers.”
Many tumours respond to little or no therapies, to generate an antitumor immune response and are thus considered to be ” cold “. This lack of response is mainly due to the low immunogenicity of these tumors. The ability of NBTXR3 to induce cell death to be immunogenic (DCI) to the level of intratumoral could be the key to stimulate specifically the patients ‘ immune system and thus help to fight against their cancer.
To generate these results, Nanobiotix has analyzed samples of patients from its clinical trial of the most advanced led in the soft-tissue sarcoma, tumors typically ” cold “. The first results show that the product NBTXR3 in combination with radiation therapy would induce an antitumor immune response contributing to convert tumors “cold” tumors ” hot “. In this study, no response of this type has been observed with radiotherapy alone.
Key results
Specific adaptive immune pattern induced by NBTXR3 when exposed to radiation therapy in Soft Tissue Sarcoma (STS) patients (#e14615).
Jérôme Galon, Marick Laé, Zsuzsanna Papai, Philippe Rochaix, Laszlo Csaba Mangel, Bernhard Mlecnik, Fabienne Hermitte, Zoltan Sapi, Martine Delannes, Tamas Tornoczky, Anne Vincent-Salomon, Sylvie Bonvalot; INSERM, Paris, France; Institut Curie, Paris, France; Magyar Honvedseg Egeszsegugyi Kozpont, Budapest, Hungary; Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, France; Pecs University, Pecs, Hungary; HalioDX, Marseille, France; Semmelweis University, Budapest, Hungary.
In this study, tumor tissues from the trial of phase II/III were examined upstream and downstream of the treatment in patients with soft tissue sarcoma locally advanced. These samples were collected from patients who received either the product NBTXR3 by intratumoral injection combined with radiotherapy (14 patients), or treatment by radiation therapy alone (12 patients).
The results observed in the analysis of post-treatment patients treated with NBTXR3 and radiation therapy, have shown a significant increase in the infiltration of immune cells (CD3, CD8). In contrast, no difference was observed between the analysis of pre-and post-treatment patients treated with radiotherapy alone.
Similarly, patients who received NBTXR3 and radiation therapy showed an increase in their “immunoscore” post-treatment compared to those treated by radiotherapy alone.
A comparison of the expression levels of hundreds of genes on tumor samples obtained before and after radiotherapy treatment, with and without NBTXR3 has been carried out. An increase in the expression of genes involved in the response of the immune adaptive was measured post-treatment in patients treated with NBTXR3 and radiation therapy, which was not observed in patients treated with radiotherapy alone.
Among these genes, the study shows the overexpression of cytokines (IL7, IFNA, IL16, IL11, IFNG), of the adaptive immune response (RAG1, GZMA, TAP1, TAP2, TBX21, STAT4, IFNG, LCK, LTK, CD37, CD22) and the signaling pathways of receptors lymphocyte T (CD28, CTLA4, CD274, BTLA, TIGIT, CD40LG, CD5+, CD3Ε, ZAP70).
These first data suggest that NBTXR3 could be, in combination with radiotherapy, an agent of Immuno-Oncology that can trigger an antitumor immune response specific. These results also open potential combinations, since several of the upregulated genes represent therapeutic targets that already exist or are promising in Immuno-Oncology, such as products targeting PD1, PDL1, CTLA4, etc. – These first data will be the subject of further studies for confirmation.
Competitive positioning of NBTXR3 in IO
Many of the strategies of combination of IO focus on the priming of anti-tumor (” priming “), a necessary step to transform a tumor “cold” tumor ” hot “.
In this perspective, NBTXR3 could have many benefits, compared to products that can be used for priming anti-tumor : a mode of physical action and universal which could be widely used in oncology ; requiring only a single local injection ; which easily fits in a medical practice the basis for the treatment of cancer ; and finally, that presents a very good profile of chronic safety, and production process of already well-established.
These new clinical data, along with preclinical data already obtained, indicate that NBTXR3 could play a key role in oncology, and could become a pillar of the Immuno-Oncology.
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About NBTXR3
NBTXR3 is a ” radio-enhancer “, the first of a new class of products, designed to be injected directly into tumours in order to increase the dose and efficacy of radiotherapy without increasing toxicity or damage to the surrounding healthy tissue. NBTXR3 is currently in advanced stages of clinical development.
The global clinical development include clinical trials in 7 populations of patients :
Soft Tissue sarcoma (MCS)
A phase I/II ended
A phase II/III ” Act.in.sarc ” in Europe, South Africa and Asia-Pacific
Cancers of the Head and Neck
A phase I/II in France and Spain ; NBTXR3 + rt alone
A phase I/II conducted by PharmaEngine in Asia-Pacific ; NBTXR3 + radiation therapy and chemotherapy
Prostate Cancers
A phase I/II in the United States
Cancer of the Liver
A phase I/II when the cancer is hepatocellular in France
A phase I/II for liver metastases in France
Cancers of the Rectum
A phase I/II conducted by PharmaEngine in Asia-Pacific
The Company has filed the first application for authorisation of the placing on the market in Europe (CE Marking).
About NANOBIOTIX www.nanobiotix.com/fr
Nanobiotix, a spin-off of the University of Buffalo, SUNY, was created in 2003. Company a pioneer and leader in nanomedicine has developed a revolutionary approach in the treatment of cancer. The Company focuses its effort on the development of its portfolio of products fully patented NanoXray, innovation based on the mode of physical action of the nanoparticles which, under the action of radiation, in order to maximize the absorption of X-rays to the interior of cancer cells in order to destroy them more effectively.
Products NanoXray are compatible with the treatments of radiation standards and are designed to potentially handle a wide variety of solid cancers (including Soft Tissue Sarcomas, cancers of the Head and Neck, Liver cancers, Prostate cancers, Breast cancers, Glioblastoma…) and by multiple routes of administration.
NBTXR3 is currently tested in several clinical studies in patients with Soft Tissue Sarcoma, cancers of the Head and Neck, cancers of the Prostate, and Liver cancers (HCC and liver metastases) and conducted by PharmaEngine, partner of Nanobiotix in the Asia-Pacific region : cancer of the head and neck and rectum. The Company has filed in August 2016 the application of the CE marking to the product, NBTXR3.
The Company has launched in 2016 in a new research program in Immuno-Oncology with its lead product NBTXR3, which could potentially bring a new dimension to the immunotherapy in oncology.
Nanobiotix ipo in October 2012. The Company is listed on the regulated market of Euronext in Paris (ISIN Code : FR0011341205, code mnemonic Euronext: NANO, Bloomberg code: NANO:FP). The registered office of the Company is located in Paris, France. The Company has a subsidiary in Cambridge, United States.
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