NANOBIOTIX Announces New Results From a Phase 1 Study Evaluating JNJ-1900 (NBTXR3) in Combination With Immune Checkpoint Inhibitors as a 2L+ Therapy for Patients With Primary Cutaneous Melanoma Resistant to Anti-PD-1

• Data show a favorable safety profile and early efficacy signals in a heavily pre-treated population whose cancer progressed after multiple prior lines of therapy including anti-PD-1
• Recommended phase 2 dose (RP2D) established at 33% of gross tumor volume (GTV)
• 47.4% (9/19) best observed objective response rate (ORR) in all lesions per RECIST 1.1
• 78.9% (15/19) best observed disease control rate (DCR) in all lesions per RECIST 1.1
• 14.6 months median Overall Survival (mOS) in all patients treated (n=21)
• Investigators concluded that these data warrant further investigation in randomized clinical trials as a potential new option for patients with primary cutaneous melanoma naïve or refractory to anti-PD-1
• Nanobiotix will host a conference call to discuss the data on September 18, 2025 at 8:00AM EDT/ 2:00PM CEST

Data presented on September 17 at the 2025 Immunorad Conference

PARIS and CAMBRIDGE, Mass., Sept. 17, 2025 (GLOBE NEWSWIRE) -- NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering nanotherapeutic approaches to expand treatment possibilities for patients with cancer and other major diseases, today announced new results focused on patients with primary cutaneous melanoma from the ongoing Phase 1 Study 1100 evaluating JNJ-1900 (NBTXR3) in combination with immune checkpoint inhibitors (pembrolizumab or nivolumab) 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 (“RT”), among others. All patients received a one-time intratumoral injection of JNJ-1900 (NBTXR3) followed by RT and sequential anti–PD-1 therapy. As of the August 21, 2025, data cutoff, 21 patients had been injected with JNJ-1900 and 19 were evaluable for tumor response (2 patients were not evaluable due to lack of post-treatment imaging).

"The patients in this analysis represent one of the more difficult clinical challenges we face as many have exhausted standard therapies, including checkpoint inhibitors," said Study 1100 Coordinating Investigator Colette Shen, MD, PhD, Assistant Professor of Radiation Oncology, University of North Carolina Lineberger Comprehensive Cancer Center. "While these data are preliminary, the responses we’re seeing provide a strong signal that this treatment approach could potentially offer a new possibility for patients who need more options."