NANOBIOTIX Announces Updated Phase 1 Results Continuing to Support JNJ-1900 (NBTXR3) Plus Anti-PD-1 as a Potential New 1L or 2L+ Option in Anti-PD-1 Naïve or Resistant R/M-HNSCC

• Treatment remained well-tolerated with consistent injection feasibility in 103 heavily pre-treated patients with R/M-HNSCC naïve or resistant to anti-PD-1
• 63% (26/41) disease control rate (“DCR”) and 37% (15/41) objective response rate (“ORR”) in evaluable anti-PD-1 naïve patients per RECIST 1.1
• 74% (37/50) DCR and 32% (16/50) ORR in evaluable anti-PD-1 resistant patients per RECIST 1.1
• 15.5 months median Overall Survival (“mOS”) in evaluable anti-PD-1 naïve patients
• 11.4 months mOS in evaluable anti-PD-1 resistant patients
• Investigators concluded that these promising results warrant further exploration in randomized controlled trials

Data presented as a “Top-rated Abstract in Head and Neck Cancer” at the 2025 Annual Meeting of the American Society for Radiation Oncology (ASTRO) on September 29th

PARIS and CAMBRIDGE, Mass., Sept. 29, 2025 (GLOBE NEWSWIRE) -- 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 and other major diseases, today announced updated data from cohorts 1 and 2 of Study 1100, a multicenter Phase 1 dose escalation and expansion trial evaluating JNJ-1900 (NBTXR3) activated by radiation therapy (“RT”) followed by anti-PD-1 immune checkpoint inhibitors (pembrolizumab or nivolumab; “ICIs”) in patients with recurrent and/or metastatic head and neck squamous cell carcinoma (“R/M-HNSCC”) that is naïve (cohort 1) or resistant (cohort 2) to prior anti-PD-1 therapy. Study results were presented as a “Top-rated Abstract in Head and Neck Cancer” by Study 1100 Coordinating Investigator Colette Shen, MD, PhD, Assistant Professor of Radiation Oncology, University of North Carolina Lineberger Comprehensive Cancer Center, at the 2025 Annual Meeting of the American Society of Radiation Oncology (ASTRO).

ABSTRACT #245: PHASE 1 DOSE ESCALATION/DOSE EXPANSION TRIAL OF NBTXR3/SBRT IN COMBINATION WITH NIVOLUMAB OR PEMBROLIZUMAB FOR TREATMENT OF ANTI-PD-1 NAÏVE OR RESISTANT PATIENTS WITH RECURRENT/METASTATIC HEAD AND NECK SQUAMOUS CELL CARCINOMA
Colette Shen¹, Ammar Sukari², William A. Stokes³, George Yang⁴, Nabil F. Saba³, Jared Weiss¹, Jessica Frakes⁴, Jimmy Caudell⁴, Paul Chang⁵, Septimiu Murgu⁵, Michele Lohr⁶, Jason Chan⁷, Kedar Kirtane⁴, David Rolando⁸, Omar I. Vivar⁸, Zhen Gooi⁵, Aditya Juloori⁵, Trevor Hackman¹, Ari Rosenberg^5
1University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA; ²Karmanos Cancer Institute, Detroit, MI, USA; ³Emory Winship Cancer Institute, Atlanta, Georgia, USA; ⁴Moffitt Cancer Center, Tampa, Florida, USA; ⁵The University of Chicago, Chicago, Illinois, USA; ⁶Sanford Cancer Center, Sioux Falls, South Dakota, USA; ⁷UCSF, San Francisco, CA, USA; ⁸Nanobiotix, SA, Paris, France