Nanobiotix announces new results from JNJ-1900 study

Nanobiotix (NBTX) announced new results focused on patients with primary cutaneous melanoma from the ongoing Phase 1 Study 1100 evaluating JNJ-1900 in combination with immune checkpoint inhibitors for patients with advanced cancers. These findings were presented at the 2025 ImmunoRad conference in Paris, France on September 17. Patients with anti-PD-1 resistant primary cutaneous melanoma in the study had advanced disease that progressed despite multiple prior lines of therapy, including anti-PD-1, ipilimumab, T-VEC, TIL, and radiotherapy, among others. All patients received a one-time intratumoral injection of JNJ-1900 followed by RT and sequential anti-PD-1 therapy. As of the August 21, data cutoff, 21 patients had been injected with JNJ-1900 and 19 were evaluable for tumor response. All 21 patients with primary cutaneous melanoma had shown prior resistance to anti-PD-1 and treatment with RT-activated JNJ-1900 followed by anti-PD-1 showed a favorable safety profile. Injection feasibility was confirmed at the recommended Phase 2 dose. In total, 16 patients experienced grade 1, grade 2, or grade 3+ TEAEs related to the overall therapeutic regimen. Of which 5 patients experienced grade 1, grade 2, or grade 3+ treatment-emergent adverse events related to JNJ-1900 and/or the injection procedure. Of these patients, 1 patient experienced grade 3+ TEAEs. JNJ-1900 demonstrated preliminary signals of efficacy in 19 patients who were evaluable for tumor response. A best observed objective response rate in all lesions of 47.4% per RECIST 1.1, including 4 complete responses and 5 partial responses. A best observed disease control rate in all lesions of 78.9% per RECIST 1.1. In JNJ-1900 injected & irradiated tumors, a DCR of 100% was observed. A median overall survival of 14.6 months in all patients treated. Notably, a relationship was observed between the depth of local response and systemic tumor regression, suggesting a possible priming or re-activation of immune response. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of JNJ-1900 with Janssen Pharmaceutica, a Johnson & Johnson (JNJ) company.