Nanobiotix(US:NBTX) Globenewswire·2025-09-29 22:30Core Insights - NANOBIOTIX presented updated data from Study 1100, a Phase 1 trial evaluating JNJ-1900 (NBTXR3) in combination with radiation therapy and anti-PD-1 inhibitors for patients with recurrent and/or metastatic head and neck squamous cell carcinoma [1][2][3] Study Results - The study included two cohorts: anti-PD-1 naïve patients and anti-PD-1 resistant patients, with a total of 103 heavily pre-treated participants [3][4] - In anti-PD-1 naïve patients, the disease control rate (DCR) was 63% and the objective response rate (ORR) was 37% [3][9] - In anti-PD-1 resistant patients, the DCR was 74% and the ORR was 32% [3][9] - Median overall survival (mOS) was 15.5 months for anti-PD-1 naïve patients and 11.4 months for anti-PD-1 resistant patients [3][9] Safety and Feasibility - The treatment was well-tolerated, with a favorable safety profile and no additional toxicities observed in lesions injected after re-irradiation [4][3] - A total of 71 patients experienced treatment-emergent adverse events (TEAEs) related to the therapeutic regimen [4] Efficacy Signals - The study indicated strong local control with an aggregate DCR of 95% in injected lesions, suggesting potential systemic responses beyond the injected area [5][3] - Early survival data suggests that JNJ-1900 may overcome prior resistance to immune checkpoint inhibitors [5][6] Product Overview - JNJ-1900 (NBTXR3) is a novel oncology product utilizing functionalized hafnium oxide nanoparticles, administered via intratumoral injection and activated by radiotherapy [7] - The product has shown proof-of-concept in soft tissue sarcomas and is being evaluated across multiple solid tumor indications [8][7] Collaboration and Development - NANOBIOTIX has engaged in a collaboration strategy to expand the development of JNJ-1900, including a partnership with The University of Texas MD Anderson Cancer Center and a license agreement with Johnson & Johnson for global co-development [11][12]