PharmaEngine Inc.

Taipei, Taiwan

PharmaEngine Inc.

Taipei, Taiwan
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NANOBIOTIX ANNOUNCES FIRST POSITIVE HUMAN DATA SHOWING THAT NBTXR3 COULD BECOME A BACKBONE IN IMMUNO-ONCOLOGY Paris, France and Cambridge, Massachusetts, (USA) May 18, 2017 - NANOBIOTIX (Euronext: NANO - ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, today announced its first set of clinical data from its immuno-oncology (IO) program, showing the potential ability of NBTXR3 to transform "cold" tumors into "hot" tumors. Laurent Levy, CEO of Nanobiotix said, "Being able to transform cold tumors into hot tumors is one of the most challenging and promising topics in oncology. This preliminary clinical data indicates that NBTXR3 could play a key role in unlocking this potential. Given NBTXR3's universal type mode of action and good safety profile, NBTXR3 could change the treatment landscape in numerous solid tumor cancers." Many tumors exhibit little or no response to therapies targeting the immune system and are considered "cold".  The explanation for the lack of response in its simplest form is a lack of immunogenicity.  The ability of NBTXR3 to generate intratumoral immunogenic cell death (ICD) could be a key to significantly increase the number of patients who can engage their immune system to fight their cancer. To undertake this research, Nanobiotix used the available patient samples from its more advanced indication of soft tissue sarcoma -- a typical "cold" tumor. These findings demontrated that NBTXR3 plus radiotherapy induces a specific adaptive immune pattern, which could potentially contribute to converting a "cold" tumor into a "hot" tumor. In this study, radiotherapy alone did not show any impact on triggering adaptive immune response. 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, tumors from the ongoing two-arm Phase II/III clinical trial were examined both pre- and post-treatment in patients with locally advanced soft tissue sarcoma who had received either NBTXR3 with radiotherapy (14 patients) or radiotherapy alone (12 patients). The results observed in the post-treatment examination of patients who received both NBTXR3 and radiotherapy, showed a significant increase of immune cell infiltration (CD3+, CD8+). In contrast, there were no differences observed between pre- and post-treatment examination where patients received radiotherapy alone. Similarly, patients who received NBTXR3 plus radiotherapy were found to have an increased immunoscore post-treatment, compared to those who received radiotherapy alone. The upregulation of pan-immune gene expression and specifically, the expression of adaptive immunity genes between pre- and post-treatment, was pronounced in the post-treatment results of patients who received NBTXR3 plus radiotherapy compared to those who received radiotherapy alone. Furthermore, a functional analysis of upregulated genes in NBTXR3 plus radiotherapy showed a specific enrichment of cytokine activity (IL7, IFNA, IL16, IL11, IFNG), adaptive immunity (RAG1, GZMA, TAP1, TAP2, TBX21, STAT4, IFNG, LCK, LTK, CD37, CD22) and T-cell receptor signaling pathway (CD28, CTLA4, CD274, BTLA, TIGIT, CD40LG, CD5, CD3E, ZAP70). The initial data suggests NBTXR3's potential as an IO agent that could, on its own, trigger a specific immune response against the tumor. A number of upregulated genes correspond to existing or promising IO targets, enabling potential combination of NBTXR3 with therapeutic approaches, like products targeting PD1, PDL1, CTLA4, etc. This data requires confirmation in additional studies. Many IO combination strategies focus on 'priming' the tumor, which is now becoming a prerequisite of turning a "cold" tumor into a "hot" tumor. Compared to other modalities that could be used for priming the tumor, NBTXR3 could have a number of advantages: the physical and universal mode of action that could be used widely across oncology,  the one-time local injection and good fit within existing medical practice already used as a basis for cancer treatment, as well as  a  very good chronic safety profile and well-established manufacturing process. The new clinical data and previous pre-clinical data indicate that NBTXR3 could play a key role in oncology and could become a backbone in immuno-oncology. About NBTXR3 Nanobiotix's lead product, NBTXR3, is a first-in-class radio-enhancer nanoparticle designed for direct injection into cancerous tumors. It has been engineered to increase the dose and efficacy of radiotherapy without increasing toxicity or causing damage to surrounding healthy tissues. NBTXR3 is currently in late-stage clinical development as a single agent. Worldwide clinical development of NBTXR3 now includes trials across 7 patient populations: Phase I/II trial in France and Spain; NBTXR3 + Radiotherapy alone Phase I/II trial by PharmaEngine in Asia-Pacific; NBTXR3 + Radiotherapy & Chemotherapy Phase I/II trial in the U.S First market approval has been filed in the EU. * 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 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. The Company started in 2016 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 Headquarter is based in Paris, France. Affiliate in Cambridge, United States. 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 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.


News Article | April 28, 2017
Site: www.acnnewswire.com

NANOBIOTIX (Euronext: NANO - ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, today announces its audited consolidated results for the fiscal year ended December 31, 2016: - Expansion of Nanobiotix clinical development program - six clinical trials running in seven indications-activities in relation to the market access of NBTX3, Nanobiotix' lead product, have impacted operating expenses as planned - Increase of revenues with a $1M milestone payment from PharmaEngine - Consolidation of the cash available at EUR 21.1M strengthened by the completion of a private placement executed in March 2016 Income statement 2016 2015 ---------------------------------------------------------------------- Total revenue EUR 5,421,613 4,015,229 ---------------------------------------------------------------------- Sales 1,558,101 265,543 License 1,075,372 183,893 Other sales 99,450 66,179 Services 383,279 15,471 ---------------------------------------------------------------------- Other revenue 3,863,512 3,749,686 Subsidies 98,095 199,838 Research Tax Credit 3,703,278 3,546,035 Other 62,139 3,814 Cost of sales -- -- R&D costs (16,915,243) (13,901,898) Selling, General and Administrative (SG&A) (8,370,208) (5,963,488) (Market Access, BD & other corporate costs) Costs associated with payments in shares (1,990,855) (1,291,491) ---------------------------------------------------------------------- Core operating loss (21,854,693) (17,141,647) ---------------------------------------------------------------------- Net Interest Income (*) 64,607 138,562 ---------------------------------------------------------------------- Core pre-tax loss (21,790,086) (17,003,084) ---------------------------------------------------------------------- Tax (90,425) -- ---------------------------------------------------------------------- Net Profit & Loss (21,880,511) (17,003,084) ---------------------------------------------------------------------- * Interest Income minus Interest Expenses Financial Review Total Revenue in 2016 amounts to EUR 5.4M vs. EUR 4.0M in 2015 mainly due to: - Sales revenue from PharmaEngine amount to EUR 1,558K (vs. EUR 265,5K in 2015), with (1) EUR 184K coming from the upfront payment received in 2012 and linearized on an annual basis (2) EUR 890K (US$ 1M) coming from a milestone payment triggered by the injection of the first patient in Nanobiotix' Soft Tissue Sarcoma (STS) pivotal phase, and (3) EUR 483K for re-invoicing of services and material; and - Other revenue of EUR 3,863.5K (vs. EUR 3,749.7K in 2015) mainly generated by the Research Tax Credit (CIR) and evolving in correlation with the level of R&D activities. Total Operating expenses reach EUR 27.3M in 2016 vs. EUR 21.2M in 2015: - R&D expenses at EUR 16.9M (+EUR 3M) to support the acceleration of clinical programs (EUR 7.2M), the manufacturing activities (EUR 3.5M) and the preclinical research developments (EUR 3.9M) - SG&A costs reached EUR 8.4M (+EUR 2.4M) mainly due to the ongoing support in market access and launch readiness (EUR 2.5M), Business Development activities (EUR 1,3M) and other corporate costs, in accordance with the group development plan - Cost associated with share based payment reached EUR 2.0M in 2016 (vs. EUR 1.3M in 2015) which proceeds to an accounting evaluation (non-cash expenses). Total consolidated Headcount reached 67 FTEs in 2016 vs. 60 FTEs in 2015 in line with the development of the company. Total loss after tax amounts to EUR -21,9M (vs. EUR -17,0M FYE 2015) in line with planned operations. FYE 2016 cash available amounts to EUR 21.1M as per expectations. In April 2017 the Company has completed a private placement of EUR 25.1M providing additional resources to support the group development. This operation has been the opportunity for Nanobiotix institutional shareholders to reinforce their position and to welcome new shareholders from US and EU. Post year-end events Recommendation to continue the Phase II/III study in Soft Tissue Sarcoma- In March 2017, Nanobiotix announced that the Independent Data Monitoring Committee (IDMC) recommended the continuation of the ongoing phase II/III trial of NBTXR3 in Soft Tissue Sarcoma (Act.in.sarc study), based on the safety and efficacy data. The interim evaluation was based on an analysis of the results of two-thirds of the patients included in the Phase II/III study - 104 patients were analyzed out of a total of 156. The completion of recruitment is planned by the end of Q2 2017 and the full data is expected by the end of 2017. Presentation of NBTXR3 preclinical data- Nanobiotix announced in March 2017, the presentation of NBTXR3 preclinical studies demonstrating 1) the antitumor efficacy of NBTXR3 in five different in vivo human cancer models and 2) the antitumor efficacy of NBTXR3 in combination with chemotherapy, in both in vitro and in vivo studies. These data have been presented at the American Association for Cancer Research (AACR) Annual Meeting 2017 in Washington, D.C (April 1-5, 2017). Presentation of NBTXR3 clinical data- Nanobiotix announced in April 2017 the presentation of the Phase I/II data of Nanobiotix's European head and neck trial with NBTXR3 at the American Society of Clinical Oncology (ASCO) Annual Meeting in June. The Company also announced the expansion of Nanobiotix's Immuno-Oncology program into patients focused on the objective of turning cold tumors into hot tumors and will present the first clinical data from this program mid-year. Completion of a private placement of EUR 25,1M- To reinforce its development, Nanobiotix completed a EUR 25.1 million private placement in early April 2017, corresponding to 1,596,527 new shares, which have been placed with qualified institutional investors in the United States and Europe. The order book was well covered based on strong demand from new life sciences specialist and generalist investors as well as existing shareholders reinforcing their position. This private placement will be used for i) next clinical steps of the head and neck cancer program with NBTXR3, both in the U.S. and Europe, (ii) market preparations for NBTXR3's launch on the European market, (iii) expansion of Nanobiotix's Immuno-Oncology program into patients, and (iv) general corporate purposes. Governance- Beginning of 2017, Nanobiotix appointed Alain Dostie, a senior executive from the pharmaceutical industry, as its Chief Operating Officer (COO) to oversee operations and product commercialization. Next financial press release: revenue for Q1 2017 on May 15, 2017. 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 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. The Company started in 2016 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 Headquarter is based in Paris, France. Affiliate in Cambridge, United States. Contact: Nanobiotix Sarah Gaubert Director, Communications & Public Affairs +33 1 40 26 07 55 / Noel Kurdi Director, Investor Relations +1 646 241 4400 / Media relations France - Springbok Consultants Marina Rosoff +33 6 71 58 00 34 United States - RooneyPartners Marion Janic +1 212 223 4017 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 (Autorite des Marches 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. 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.


NANOBIOTIX (Paris:NANO) (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, today announced its first set of clinical data from its immuno-oncology (IO) program, showing the potential ability of NBTXR3 to transform “cold” tumors into “hot” tumors. Laurent Levy, CEO of Nanobiotix said, “Being able to transform cold tumors into hot tumors is one of the most challenging and promising topics in oncology. This preliminary clinical data indicates that NBTXR3 could play a key role in unlocking this potential. Given NBTXR3’s universal type mode of action and good safety profile, NBTXR3 could change the treatment landscape in numerous solid tumor cancers.” Many tumors exhibit little or no response to therapies targeting the immune system and are considered “cold”. The explanation for the lack of response in its simplest form is a lack of immunogenicity. The ability of NBTXR3 to generate intratumoral immunogenic cell death (ICD) could be a key to significantly increase the number of patients who can engage their immune system to fight their cancer. To undertake this research, Nanobiotix used the available patient samples from its more advanced indication of soft tissue sarcoma -- a typical “cold” tumor. These findings demontrated that NBTXR3 plus radiotherapy induces a specific adaptive immune pattern, which could potentially contribute to converting a “cold” tumor into a “hot” tumor. In this study, radiotherapy alone did not show any impact on triggering adaptive immune response. Specific adaptive immune pattern induced by NBTXR3 when exposed to radiation therapy in Soft Tissue Sarcoma (STS) patients (#e14615) In this study, tumors from the ongoing two-arm Phase II/III clinical trial were examined both pre- and post-treatment in patients with locally advanced soft tissue sarcoma who had received either NBTXR3 with radiotherapy (14 patients) or radiotherapy alone (12 patients). The results observed in the post-treatment examination of patients who received both NBTXR3 and radiotherapy, showed a significant increase of immune cell infiltration (CD3+, CD8+). In contrast, there were no differences observed between pre- and post-treatment examination where patients received radiotherapy alone. Similarly, patients who received NBTXR3 plus radiotherapy were found to have an increased immunoscore post-treatment, compared to those who received radiotherapy alone. The upregulation of pan-immune gene expression and specifically, the expression of adaptive immunity genes between pre- and post-treatment, was pronounced in the post-treatment results of patients who received NBTXR3 plus radiotherapy compared to those who received radiotherapy alone. Furthermore, a functional analysis of upregulated genes in NBTXR3 plus radiotherapy showed a specific enrichment of cytokine activity (IL7, IFNA, IL16, IL11, IFNG), adaptive immunity (RAG1, GZMA, TAP1, TAP2, TBX21, STAT4, IFNG, LCK, LTK, CD37, CD22) and T-cell receptor signaling pathway (CD28, CTLA4, CD274, BTLA, TIGIT, CD40LG, CD5, CD3E, ZAP70). The initial data suggests NBTXR3’s potential as an IO agent that could, on its own, trigger a specific immune response against the tumor. A number of upregulated genes correspond to existing or promising IO targets, enabling potential combination of NBTXR3 with therapeutic approaches, like products targeting PD1, PDL1, CTLA4, etc. This data requires confirmation in additional studies. Many IO combination strategies focus on ‘priming’ the tumor, which is now becoming a prerequisite of turning a “cold” tumor into a “hot” tumor. Compared to other modalities that could be used for priming the tumor, NBTXR3 could have a number of advantages: the physical and universal mode of action that could be used widely across oncology, the one-time local injection and good fit within existing medical practice already used as a basis for cancer treatment, as well as a very good chronic safety profile and well-established manufacturing process. The new clinical data and previous pre-clinical data indicate that NBTXR3 could play a key role in oncology and could become a backbone in immuno-oncology. Nanobiotix’s lead product, NBTXR3, is a first-in-class radio-enhancer nanoparticle designed for direct injection into cancerous tumors. It has been engineered to increase the dose and efficacy of radiotherapy without increasing toxicity or causing damage to surrounding healthy tissues. NBTXR3 is currently in late-stage clinical development as a single agent. Worldwide clinical development of NBTXR3 now includes trials across 7 patient populations: 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 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. The Company started in 2016 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 Headquarter is based in Paris, France. Affiliate in Cambridge, United States. 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.


Specific adaptive immune pattern induced by NBTXR3 when exposed to radiation therapy in Soft Tissue Sarcoma (STS) patients (#e14615) Une comparaison des niveaux d’expression de centaines de gènes sur des échantillons de tumeurs obtenus avant et après traitement de radiothérapie, avec et sans NBTXR3, a été réalisée. Une augmentation de l’expression de gènes impliqués dans la réponse immunitaires adaptative a été mesurée post-traitement chez les patients ayant reçu NBTXR3 et radiothérapie, ce qui n’a pas été observé chez les patients traités par radiothérapie seule. Dans cette perspective, NBTXR3 pourrait avoir de nombreux avantages, comparé aux produits pouvant être utilisés pour l'amorçage anti-tumoral : un mode d'action physique et universel qui pourrait être largement utilisé en oncologie ; ne nécessitant qu’une unique injection locale ; qui s’insère aisément dans une pratique médicale de base pour le traitement du cancer ; et enfin qui présente un très bon profil chronique de sécurité et un processus de fabrication d’ores et déjà bien établi. Les produits NanoXray sont compatibles avec les traitements de radiothérapie standards et visent à traiter potentiellement une grande variété de cancers solides (y compris les Sarcomes des Tissus Mous, les cancers de la Tête et du Cou, les cancers du Foie, les cancers de la Prostate, les cancers du Sein, le Glioblastome...) et cela par de multiples voies d'administration. NBTXR3 est actuellement testé au cours de plusieurs études cliniques chez des patients atteints de Sarcome des Tissus Mous, de cancers de la Tête et du Cou, de cancers de la Prostate, et de cancers du Foie (CHC et métastases hépatiques) et menés par PharmaEngine, partenaire de Nanobiotix en région Asie-Pacifique : cancers de la tête et du cou et du rectum. La Société a déposé en août 2016 le dossier de demande de marquage CE pour le produit NBTXR3. Le présent communiqué contient des déclarations prospectives relatives à Nanobiotix et à ses activités, y compris ses perspectives. Nanobiotix estime que ces déclarations prospectives reposent sur des hypothèses raisonnables. Cependant, des déclarations prospectives ne constituent pas des garanties d’une performance future, étant donné qu’elles portent sur des événements futurs et dépendent de circonstances qui pourraient ou non se réaliser dans le futur, et de divers risques et incertitudes, dont ceux décrits dans le document de référence de Nanobiotix déposé auprès de l’Autorité des marchés financiers (AMF) le 28 avril 2017 (numéro de dépôt D.17-0470) et disponible sur le site internet de la Société (www.nanobiotix.com), et de l’évolution de la conjoncture économique, des marchés financiers et des marchés sur lesquels Nanobiotix est présente. Les déclarations prospectives figurant dans le présent communiqué sont également soumises à des risques inconnus de Nanobiotix ou que Nanobiotix ne considère pas comme significatifs à cette date. La réalisation de tout ou partie de ces risques pourrait conduire à ce que les résultats réels, conditions financières, performances ou réalisations de Nanobiotix diffèrent significativement des résultats, conditions financières, performances ou réalisations exprimés dans ces déclarations prospectives. Nanobiotix décline toute responsabilité quant à la mise à jour de ces déclarations prospectives.


NANOBIOTIX ANNOUNCES FIRST POSITIVE HUMAN DATA SHOWING THAT NBTXR3 COULD BECOME A BACKBONE IN IMMUNO-ONCOLOGY Paris, France and Cambridge, Massachusetts, (USA) May 18, 2017 - NANOBIOTIX (Euronext: NANO - ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, today announced its first set of clinical data from its immuno-oncology (IO) program, showing the potential ability of NBTXR3 to transform "cold" tumors into "hot" tumors. Laurent Levy, CEO of Nanobiotix said, "Being able to transform cold tumors into hot tumors is one of the most challenging and promising topics in oncology. This preliminary clinical data indicates that NBTXR3 could play a key role in unlocking this potential. Given NBTXR3's universal type mode of action and good safety profile, NBTXR3 could change the treatment landscape in numerous solid tumor cancers." Many tumors exhibit little or no response to therapies targeting the immune system and are considered "cold".  The explanation for the lack of response in its simplest form is a lack of immunogenicity.  The ability of NBTXR3 to generate intratumoral immunogenic cell death (ICD) could be a key to significantly increase the number of patients who can engage their immune system to fight their cancer. To undertake this research, Nanobiotix used the available patient samples from its more advanced indication of soft tissue sarcoma -- a typical "cold" tumor. These findings demontrated that NBTXR3 plus radiotherapy induces a specific adaptive immune pattern, which could potentially contribute to converting a "cold" tumor into a "hot" tumor. In this study, radiotherapy alone did not show any impact on triggering adaptive immune response. 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, tumors from the ongoing two-arm Phase II/III clinical trial were examined both pre- and post-treatment in patients with locally advanced soft tissue sarcoma who had received either NBTXR3 with radiotherapy (14 patients) or radiotherapy alone (12 patients). The results observed in the post-treatment examination of patients who received both NBTXR3 and radiotherapy, showed a significant increase of immune cell infiltration (CD3+, CD8+). In contrast, there were no differences observed between pre- and post-treatment examination where patients received radiotherapy alone. Similarly, patients who received NBTXR3 plus radiotherapy were found to have an increased immunoscore post-treatment, compared to those who received radiotherapy alone. The upregulation of pan-immune gene expression and specifically, the expression of adaptive immunity genes between pre- and post-treatment, was pronounced in the post-treatment results of patients who received NBTXR3 plus radiotherapy compared to those who received radiotherapy alone. Furthermore, a functional analysis of upregulated genes in NBTXR3 plus radiotherapy showed a specific enrichment of cytokine activity (IL7, IFNA, IL16, IL11, IFNG), adaptive immunity (RAG1, GZMA, TAP1, TAP2, TBX21, STAT4, IFNG, LCK, LTK, CD37, CD22) and T-cell receptor signaling pathway (CD28, CTLA4, CD274, BTLA, TIGIT, CD40LG, CD5, CD3E, ZAP70). The initial data suggests NBTXR3's potential as an IO agent that could, on its own, trigger a specific immune response against the tumor. A number of upregulated genes correspond to existing or promising IO targets, enabling potential combination of NBTXR3 with therapeutic approaches, like products targeting PD1, PDL1, CTLA4, etc. This data requires confirmation in additional studies. Many IO combination strategies focus on 'priming' the tumor, which is now becoming a prerequisite of turning a "cold" tumor into a "hot" tumor. Compared to other modalities that could be used for priming the tumor, NBTXR3 could have a number of advantages: the physical and universal mode of action that could be used widely across oncology,  the one-time local injection and good fit within existing medical practice already used as a basis for cancer treatment, as well as  a  very good chronic safety profile and well-established manufacturing process. The new clinical data and previous pre-clinical data indicate that NBTXR3 could play a key role in oncology and could become a backbone in immuno-oncology. About NBTXR3 Nanobiotix's lead product, NBTXR3, is a first-in-class radio-enhancer nanoparticle designed for direct injection into cancerous tumors. It has been engineered to increase the dose and efficacy of radiotherapy without increasing toxicity or causing damage to surrounding healthy tissues. NBTXR3 is currently in late-stage clinical development as a single agent. Worldwide clinical development of NBTXR3 now includes trials across 7 patient populations: Phase I/II trial in France and Spain; NBTXR3 + Radiotherapy alone Phase I/II trial by PharmaEngine in Asia-Pacific; NBTXR3 + Radiotherapy & Chemotherapy Phase I/II trial in the U.S First market approval has been filed in the EU. * 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 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. The Company started in 2016 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 Headquarter is based in Paris, France. Affiliate in Cambridge, United States. 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 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.


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. Une comparaison des niveaux d'expression de centaines de gènes sur des échantillons de tumeurs obtenus avant et après traitement de radiothérapie, avec et sans NBTXR3, a été réalisée. Une augmentation de l'expression de gènes impliqués dans la réponse immunitaires adaptative a été mesurée post-traitement chez les patients ayant reçu NBTXR3 et radiothérapie, ce qui n'a pas été observé chez les patients traités par radiothérapie seule. Dans cette perspective, NBTXR3 pourrait avoir de nombreux avantages, comparé aux produits pouvant être utilisés pour l'amorçage anti-tumoral : un mode d'action physique et universel qui pourrait être largement utilisé en oncologie ; ne nécessitant qu'une unique injection locale ; qui s'insère aisément dans une pratique médicale de base pour le traitement du cancer ; et enfin qui présente un très bon profil chronique de sécurité et un processus de fabrication d'ores et déjà bien établi. Les produits NanoXray sont compatibles avec les traitements de radiothérapie standards et visent à traiter potentiellement une grande variété de cancers solides (y compris les Sarcomes des Tissus Mous, les cancers de la Tête et du Cou, les cancers du Foie, les cancers de la Prostate, les cancers du Sein, le Glioblastome...) et cela par de multiples voies d'administration. NBTXR3 est actuellement testé au cours de plusieurs études cliniques chez des patients atteints de Sarcome des Tissus Mous, de cancers de la Tête et du Cou, de cancers de la Prostate, et de cancers du Foie (CHC et métastases hépatiques) et menés par PharmaEngine, partenaire de Nanobiotix en région Asie-Pacifique : cancers de la tête et du cou et du rectum. La Société a déposé en août 2016 le dossier de demande de marquage CE pour le produit NBTXR3. Le présent communiqué contient des déclarations prospectives relatives à Nanobiotix et à ses activités, y compris ses perspectives. Nanobiotix estime que ces déclarations prospectives reposent sur des hypothèses raisonnables. Cependant, des déclarations prospectives ne constituent pas des garanties d'une performance future, étant donné qu'elles portent sur des événements futurs et dépendent de circonstances qui pourraient ou non se réaliser dans le futur, et de divers risques et incertitudes, dont ceux décrits dans le document de référence de Nanobiotix déposé auprès de l'Autorité des marchés financiers (AMF) le 28 avril 2017 (numéro de dépôt D.17-0470) et disponible sur le site internet de la Société (www.nanobiotix.com), et de l'évolution de la conjoncture économique, des marchés financiers et des marchés sur lesquels Nanobiotix est présente. Les déclarations prospectives figurant dans le présent communiqué sont également soumises à des risques inconnus de Nanobiotix ou que Nanobiotix ne considère pas comme significatifs à cette date. La réalisation de tout ou partie de ces risques pourrait conduire à ce que les résultats réels, conditions financières, performances ou réalisations de Nanobiotix diffèrent significativement des résultats, conditions financières, performances ou réalisations exprimés dans ces déclarations prospectives. Nanobiotix décline toute responsabilité quant à la mise à jour de ces déclarations prospectives.


Nanobiotix Announces First Positive Human Data Showing That NBTXR3 Could Become a Backbone in Immuno-Oncology - Biomarker two-arm study in 26 Soft Tissue Sarcoma patients - Data shows a specific, adaptive immune pattern triggered by NBTXR3 treatment - Potential synergies with Immuno-oncology drugs including checkpoint inhibitors NANOBIOTIX (Euronext: NANO - ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, today announced its first set of clinical data from its immuno-oncology (IO) program, showing the potential ability of NBTXR3 to transform "cold" tumors into "hot" tumors. Laurent Levy, CEO of Nanobiotix said, "Being able to transform cold tumors into hot tumors is one of the most challenging and promising topics in oncology. This preliminary clinical data indicates that NBTXR3 could play a key role in unlocking this potential. Given NBTXR3's universal type mode of action and good safety profile, NBTXR3 could change the treatment landscape in numerous solid tumor cancers." Many tumors exhibit little or no response to therapies targeting the immune system and are considered "cold". The explanation for the lack of response in its simplest form is a lack of immunogenicity. The ability of NBTXR3 to generate intratumoral immunogenic cell death (ICD) could be a key to significantly increase the number of patients who can engage their immune system to fight their cancer. To undertake this research, Nanobiotix used the available patient samples from its more advanced indication of soft tissue sarcoma -- a typical "cold" tumor. These findings demontrated that NBTXR3 plus radiotherapy induces a specific adaptive immune pattern, which could potentially contribute to converting a "cold" tumor into a "hot" tumor. In this study, radiotherapy alone did not show any impact on triggering adaptive immune response. Key Results - Specific adaptive immune pattern induced by NBTXR3 when exposed to radiation therapy in Soft Tissue Sarcoma (STS) patients (#e14615) Jerome Galon, Marick Lae, 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, tumors from the ongoing two-arm Phase II/III clinical trial were examined both pre- and post-treatment in patients with locally advanced soft tissue sarcoma who had received either NBTXR3 with radiotherapy (14 patients) or radiotherapy alone (12 patients). The results observed in the post-treatment examination of patients who received both NBTXR3 and radiotherapy, showed a significant increase of immune cell infiltration (CD3+, CD8+). In contrast, there were no differences observed between pre- and post-treatment examination where patients received radiotherapy alone. Similarly, patients who received NBTXR3 plus radiotherapy were found to have an increased immunoscore post-treatment, compared to those who received radiotherapy alone. The upregulation of pan-immune gene expression and specifically, the expression of adaptive immunity genes between pre- and post-treatment, was pronounced in the post-treatment results of patients who received NBTXR3 plus radiotherapy compared to those who received radiotherapy alone. Furthermore, a functional analysis of upregulated genes in NBTXR3 plus radiotherapy showed a specific enrichment of cytokine activity (IL7, IFNA, IL16, IL11, IFNG), adaptive immunity (RAG1, GZMA, TAP1, TAP2, TBX21, STAT4, IFNG, LCK, LTK, CD37, CD22) and T-cell receptor signaling pathway (CD28, CTLA4, CD274, BTLA, TIGIT, CD40LG, CD5, CD3E, ZAP70). The initial data suggests NBTXR3's potential as an IO agent that could, on its own, trigger a specific immune response against the tumor. A number of upregulated genes correspond to existing or promising IO targets, enabling potential combination of NBTXR3 with therapeutic approaches, like products targeting PD1, PDL1, CTLA4, etc. This data requires confirmation in additional studies. - NBTXR3 competitive positioning in IO Many IO combination strategies focus on 'priming' the tumor, which is now becoming a prerequisite of turning a "cold" tumor into a "hot" tumor. Compared to other modalities that could be used for priming the tumor, NBTXR3 could have a number of advantages: the physical and universal mode of action that could be used widely across oncology, the one-time local injection and good fit within existing medical practice already used as a basis for cancer treatment, as well as a very good chronic safety profile and well-established manufacturing process. The new clinical data and previous pre-clinical data indicate that NBTXR3 could play a key role in oncology and could become a backbone in immuno-oncology. About NBTXR3 Nanobiotix's lead product, NBTXR3, is a first-in-class radio-enhancer nanoparticle designed for direct injection into cancerous tumors. It has been engineered to increase the dose and efficacy of radiotherapy without increasing toxicity or causing damage to surrounding healthy tissues. NBTXR3 is currently in late-stage clinical development as a single agent. Worldwide clinical development of NBTXR3 now includes trials across 7 patient populations: - Soft Tissue Sarcoma (STS) Phase I/II trial completed Phase II/III "Act.in.Sarc." global trial (including EU, South Africa and Asia-Pacific region) - Head and Neck Cancer Phase I/II trial in France and Spain; NBTXR3 + Radiotherapy alone Phase I/II trial by PharmaEngine in Asia-Pacific; NBTXR3 + Radiotherapy & Chemotherapy - Prostate Cancer Phase I/II trial in the U.S - Liver Cancers Phase I/II Hepatocellular Cancer trial in France Phase I/II Liver Metastases trial in France - Rectal Cancer Phase I/II trial by PharmaEngine in Asia-Pacific First market approval has been filed in the EU. 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 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. The Company started in 2016 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 Headquarter is based in Paris, France. Affiliate in Cambridge, United States. Contact Nanobiotix Sarah Gaubert Director, Communications & Public Affairs +33 (0)1 40 26 07 55 / Noel Kurdi Director, Investor Relations +1 (646) 241-4400 / Media relations France - Springbok Consultants Marina Rosoff +33 (0)6 71 58 00 34 United States - RooneyPartners Marion Janic +1 (212) 223-4017 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 reference document of Nanobiotix filed with the French Financial Markets Authority (Autorite des Marches 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.


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. Une comparaison des niveaux d'expression de centaines de gènes sur des échantillons de tumeurs obtenus avant et après traitement de radiothérapie, avec et sans NBTXR3, a été réalisée. Une augmentation de l'expression de gènes impliqués dans la réponse immunitaires adaptative a été mesurée post-traitement chez les patients ayant reçu NBTXR3 et radiothérapie, ce qui n'a pas été observé chez les patients traités par radiothérapie seule. Dans cette perspective, NBTXR3 pourrait avoir de nombreux avantages, comparé aux produits pouvant être utilisés pour l'amorçage anti-tumoral : un mode d'action physique et universel qui pourrait être largement utilisé en oncologie ; ne nécessitant qu'une unique injection locale ; qui s'insère aisément dans une pratique médicale de base pour le traitement du cancer ; et enfin qui présente un très bon profil chronique de sécurité et un processus de fabrication d'ores et déjà bien établi. Les produits NanoXray sont compatibles avec les traitements de radiothérapie standards et visent à traiter potentiellement une grande variété de cancers solides (y compris les Sarcomes des Tissus Mous, les cancers de la Tête et du Cou, les cancers du Foie, les cancers de la Prostate, les cancers du Sein, le Glioblastome...) et cela par de multiples voies d'administration. NBTXR3 est actuellement testé au cours de plusieurs études cliniques chez des patients atteints de Sarcome des Tissus Mous, de cancers de la Tête et du Cou, de cancers de la Prostate, et de cancers du Foie (CHC et métastases hépatiques) et menés par PharmaEngine, partenaire de Nanobiotix en région Asie-Pacifique : cancers de la tête et du cou et du rectum. La Société a déposé en août 2016 le dossier de demande de marquage CE pour le produit NBTXR3. Le présent communiqué contient des déclarations prospectives relatives à Nanobiotix et à ses activités, y compris ses perspectives. Nanobiotix estime que ces déclarations prospectives reposent sur des hypothèses raisonnables. Cependant, des déclarations prospectives ne constituent pas des garanties d'une performance future, étant donné qu'elles portent sur des événements futurs et dépendent de circonstances qui pourraient ou non se réaliser dans le futur, et de divers risques et incertitudes, dont ceux décrits dans le document de référence de Nanobiotix déposé auprès de l'Autorité des marchés financiers (AMF) le 28 avril 2017 (numéro de dépôt D.17-0470) et disponible sur le site internet de la Société (www.nanobiotix.com), et de l'évolution de la conjoncture économique, des marchés financiers et des marchés sur lesquels Nanobiotix est présente. Les déclarations prospectives figurant dans le présent communiqué sont également soumises à des risques inconnus de Nanobiotix ou que Nanobiotix ne considère pas comme significatifs à cette date. La réalisation de tout ou partie de ces risques pourrait conduire à ce que les résultats réels, conditions financières, performances ou réalisations de Nanobiotix diffèrent significativement des résultats, conditions financières, performances ou réalisations exprimés dans ces déclarations prospectives. Nanobiotix décline toute responsabilité quant à la mise à jour de ces déclarations prospectives.

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