Nanobiotix Announces New Preclinical Data Highlighting NBTXR3 Immune Priming and Checkpoint Inhibitor Combination

Data to be presented at the 36 th  Annual Meeting of the Society for the Immunotherapy of Cancer (SITC) Data show radiotherapy-activated NBTXR3 increased CD8+ T cell infiltration and modulated the T cell receptor repertoire in a mouse model, suggesting stronger immune priming triggered by the therapy compared to radiotherapy alone Data show the combination of radiotherapy-activated NBTXR3, anti-PD-1, anti-LAG3, and anti-TIGIT significantly elevated the activities of anti-tumor immune response Paris, France; Cambridge, Massachusetts (USA); November 9, 2021  –  NANOBIOTIX  (Euronext: NANO – NASDAQ: NBTX – the ‘‘ Company ’’) ,  a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced new preclinical immunotherapy data for novel, potentially solid tumor- and therapeutic combination-agnostic radioenhancer NBTXR3 that will be presented at the 2021 Annual Meeting of the Society for the Immunotherapy of Cancer (SITC). The Company believes that these data are consistent with  recently presented clinical immunotherapy data  and support advancement of development with anti-PD-1 and emerging immune checkpoint inhibitors. “Our view is that the potential immune priming effect we have observed with NBTXR3 could make our product candidate an important combination therapy with immune checkpoint inhibitors to improve treatment outcomes for patients,” said Laurent Levy, co-founder and chief executive officer of Nanobiotix. “The new preclinical data at SITC, along with data we have evaluated in the clinical setting, present a promising path forward in immunotherapy.” Preclinical data to be presented at the meeting by Nanobiotix (Abstract #740) show that radiotherapy-activated NBTXR3 increases CD8+ T cell infiltration and modulates the T cell receptor (“TCR”) repertoire, as well as marked modulation of immunopeptidome in treated tumor cells in a mouse model. Taken together, these variations could indicate that radiotherapy-activated NBTXR3 triggers more robust immune priming than radiotherapy alone and merits further evaluation of CD8+ response and abscopal effect. The Company’s perspective is that these data further support the mechanistic rationale of combining NBTXR3 with immune checkpoint inhibitors. The preclinical data follows preliminary clinical data presented earlier in the fourth quarter of 2021 from the phase I trial (‘‘Study 1100’’) evaluating NBTXR3 in combination with the anti-PD-1 checkpoint inhibitors nivolumab (Opdivo®) or pembrolizumab (Keytruda®) in patients with locoregional recurrent (‘‘LRR’’) or recurrent and metastatic (‘‘R/M’’) head and neck squamous cell carcinoma (‘‘HNSCC’’) or with lung or liver metastases from any primary cancer that is eligible for anti-PD-1 therapy. This preliminary data for Study 1100 showed an overall AE profile consistent with radiotherapy or anti-PD-1 monotherapies.  A 56% target lesion objective response rate (80% in anti-PD-1 naïve patients; 45% in prior non-responders) was observed in evaluable patients (n=16). A 50% overall objective response rate (% response in target and non-target lesions) was observed (80% in anti-PD-1 naïve patients; 36% for prior non-responders) in evaluable patients. The potential immune priming effect of radiotherapy-activated NBTXR3 was observed in non-responders as well as anti-PD-1 naïve patients, suggesting that NBTXR3 may reverse or circumvent resistance to prior anti-PD-1 treatment. Evaluation of novel combination approaches to immunotherapy continues to be a priority for Nanobiotix, as investigators seek to expand the impact of I/O agents for the 80-85% of patients that receive limited benefits, or no benefit at all, by improving response rates and overcoming resistance to anti-PD-1. TIGIT and LAG3, members of the same receptor class as CTLA-4 and PD-1, could be the next generation of immunotherapy targets and are being investigated alone and in combination with existing anti-PD-1 agents aiming to improve patient outcomes in clinical trials. The preclinical data to be presented at SITC by The University of Texas MD Anderson Cancer Center (Abstract #575) show that radiotherapy-activated NBTXR3 plus anti-PD-1, anti-TIGIT, and anti-LAG3 (“Combo therapy”) significantly promotes the proliferation activity of CD8+ T cells, improves local and distant tumor control, and increases survival rate in mice. Only the group of mice treated with the Combo therapy had survivors and those cured mice were immune to re-injection of tumor cells, maintained a significantly higher percentage of memory CD4+ and CD8+ memory T cells, and had stronger anti-tumor immune activities than the control, suggesting the induction of long-term anti-tumor memory by the Combo therapy. “We have long believed that radiotherapy has a critical role to play in immunotherapy and that innovation in the practice is key to achieving this ambition,” said James Welsh, MD, Associate Professor of Radiation Oncology at MD Anderson. “Our preclinical research on NBTXR3 has consistently supported the potential of this new agent in combination with radiotherapy and immune checkpoint inhibitors in order to enhance immunogenic cell death. We look forward to continuing our evaluation, both in the lab and in the clinic, with the ultimate goal of improving treatment outcomes for patients.” About NANOBIOTIX Nanobiotix is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for humanity. The company’s philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life. Incorporated in 2003, Nanobiotix is headquartered in Paris, France. The company also has subsidiaries in Cambridge, Massachusetts (United States), France, Spain, Germany and Switzerland. Nanobiotix has been listed on the regulated market of Euronext in Paris since 2012 and on the Nasdaq Global Select Market in New York City since December 2020. Nanobiotix is the owner of more than 30 umbrella patents associated with three (3) nanotechnology platforms with applications in 1) oncology; 2) bioavailability and biodistribution; and 3) disorders of the central nervous system. The company's resources are primarily devoted to the development of its lead product candidate– NBTXR3 —which is the product of its proprietary oncology platform and has already achieved market authorization in Europe for the treatment of patients with soft tissue sarcoma under the brand name Hensify®. For more information about Nanobiotix, visit us at  www.nanobiotix.com  or follow us on  LinkedIn  and  Twitter . View source version on  businesswire.com :  https://www.businesswire.com/news/home/20220104005866/en/ Nanobiotix Communications Department Brandon Owens VP, Communications +1 (617) 852-4835 [email protected] Investor Relations Department Kate McNeil SVP, Investor Relations +1 (609) 678-7388 [email protected] Media Relations France –  Ulysse Communication Pierre-Louis Germain + 33 (0) 6 64 79 97 51 [email protected] US –  Porter Novelli Dan Childs +1 (781) 888-5106 [email protected] Source: Nanobiotix

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