NANOBIOTIX Announces New Results From Pre-Clinical Immuno-Oncology Study at SITC 2019

• Data presented by MD Anderson demonstrates superiority for NBTXR3 activated by radiation therapy and anti-PD-1 in combination versus the radiation therapy and anti-PD-1 combination in an in vivo anti-PD-1-resistant model
• Data show generation of adaptive immune response—turning cold tumors into hot tumors—better local control, better abscopal effect, and significantly increased survival
• Data from in vivo RadScopal model show superior local control along with significant increases in abscopal effect and survival for treatments combining NBTXR3 activated by radiation therapy with anti-PD-1 and anti-CTLA-4 versus all other tested combinations

PARIS & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Regulatory News:

NANOBIOTIX (Paris:NANO) (Euronext : NANO – ISIN : FR0011341205 – the ‘‘Company’’) today announced promising results from its pre-clinical collaboration¹ with The University of Texas MD Anderson Cancer Center. The research, which evaluated first-in-class radioenhancer NBTXR3 activated by radiation therapy in combination with anti-PD-1 and anti-CTLA-4 immune checkpoint inhibitors, was presented last week at the 2019 Annual Meeting of the Society for Immunotherapy of Cancer (SITC).

Combination of a radiation-enhancing nanoparticle, radiotherapy, and immune checkpoint inhibitors for treating metastasized lung cancer in mice – SITC 2019 Poster – 508

Yun Hu¹, Sébastien Paris², Hampartsoum B. Barsoumian¹, Mark Wasley¹, Ahmed Younes¹, DaweiChen¹, Liang P. Yang¹, Fatemeh Masrorpour¹, Maria Angelica Cortez¹, James W. Welsh<sup>1

1</sup> Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA

² Nanobiotix, Department of Translational Science, Paris, France

This pre-clinical research studied NBTXR3 activated by radiation therapy in combination with anti-PD-1 in immunocompetent mice bearing an anti-PD-1 resistant tumor on each flank—only one tumor on each mouse was irradiated. According to the data from this model, the combination treatment that included NBTXR3 and anti-PD-1 increased local control of the irradiated tumor, generated a marked abscopal effect, decreased the number of spontaneous lung metastases, and significantly increased survival when compared to other treatments in the study including anti-PD-1 combined with radiation therapy alone.

The results also show that the combination that included NBTXR3 and anti-PD-1 has the potential to achieve an equivalent abscopal effect at a lower dose of radiation. This opens the possibility for radiation de-escalation, meaning the amount of radiation therapy could be reduced without decreasing efficacy.

Additionally, the study included an in vivo RadScopal model where the second tumor received a low dose of radiation while the first tumor received a full dose. In the RadScopal model, researchers evaluated NBTXR3 activated by radiation therapy combined with anti-PD-1 and anti-CTLA-4. The data show that this combination triggered superior local control along with significant increases in abscopal effect and survival when compared to all other tested combinations. Several complete responses were observed in the second tumor of the group that received the NBTXR3 combination while none were observed in the other groups.

These results could pave the way for the use of NBTXR3 to improve treatment outcomes for immuno-oncology patients, including checkpoint inhibitor non-responders.

About NBTXR3

NBTXR3 is a first-in-class product designed to destroy tumors through physical cell death when activated by radiotherapy. NBTXR3 has a high degree of biocompatibility, requires one single administration before the first radiotherapy treatment session, and has the ability to fit into current worldwide standards of radiation care. The physical mode of action of NBTXR3 makes it applicable across solid tumors such as lung, prostate, liver, glioblastoma, and breast cancers.

NBTXR3 is actively being evaluated in head and neck cancer with locally advanced squamous cell carcinoma of the oral cavity or oropharynx in elderly and frail patients unable to receive chemotherapy or cetuximab with limited therapeutic options. Promising results have been observed in the phase I/II trial regarding local control. In the United States, based on discussions with the Food and Drug Administration (FDA) that occurred in the first half of 2019, the Company plans to begin the clinical trial authorization process in the second half of 2019 and commence a phase II/III clinical trial in locally advanced head and neck cancers.

Nanobiotix is also running an Immuno-Oncology development program. The Company received approval FDA to launch a clinical trial of NBTXR3 activated by radiotherapy in combination with anti-PD-1 antibodies in locoregional recurrent (LRR) or recurrent and metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) and lung or liver metastasis (mets) with HNSCC not amenable to re-irradiation or non-small cell lung cancer (NSCLC) as the primary tumor .

The other ongoing NBTXR3 trials are treating patients with liver cancers (hepatocellular carcinoma and liver metastasis), locally advanced or unresectable rectal cancer in combination with chemotherapy, head and neck cancer in combination with concurrent chemotherapy, and prostate adenocarcinoma. Furthermore, the company has a large-scale, comprehensive clinical research collaboration with MD Anderson (9 new phase I/II clinical trials in the United States) to evaluate NBTXR3 across head and neck, pancreatic, thoracic, lung, gastrointestinal and genitourinary cancers.

About NANOBIOTIX: www.nanobiotix.com

Incorporated in 2003, Nanobiotix is a leading, clinical-stage nanomedicine company pioneering new approaches to significantly change patient outcomes by bringing nanophysics to the heart of the cell.

The Nanobiotix philosophy is rooted in designing pioneering, physical-based approaches to bring highly effective and generalized solutions to address unmet medical needs and challenges.

Nanobiotix’s first-in-class, proprietary lead technology, NBTXR3, aims to expand radiotherapy benefits for millions of cancer patients. Nanobiotix’s Immuno-Oncology program has the potential to bring a new dimension to cancer immunotherapies.

Nanobiotix is listed on the regulated market of Euronext in Paris (Euronext: NANO / ISIN: FR0011341205; Bloomberg: NANO: FP). The Company’s headquarters are in Paris, France, with a U.S. affiliate in Cambridge, MA, and European affiliates in Spain and Germany

Disclaimer

This press release contains certain forward-looking statements concerning Nanobiotix and its business, including its prospects and product candidate development. 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 registered with the French Financial Markets Authority (Autorité des Marchés Financiers) under number R.19-018 on April 30, 2019 (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.

¹ See the Company’s press release dated April 10, 2018.

Contacts

Nanobiotix

Communications Department
Brandon Owens
VP, Communications
+1 (617) 852-4835

[email protected]

Investor Relations Department
Noel Kurdi (US)
Director, Investor Relations
+1 (646) 241-4400

[email protected]

Ricky Bhajun (EU)
Senior Manager, Investor Relations
+33 (0)1 79 97 29 99

[email protected]

Media Relations

France – Springbok Consultants
Marina Rosoff
+33 (0)6 71 58 00 34

[email protected]

US – RooneyPartners

Marion Janic

+1 (212) 223-4017

[email protected]