Important Step in the Development of JNJ-1900 from Nanobiotix

NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX) is an advanced-stage clinical biotechnology company developing physics-based approaches to expand treatment options for cancer and other major diseases. The company has announced updates on the clinical development program for JNJ-1900 (NBTXR3).

Nanobiotix has transferred full operational control of Phase 3 clinical trials to Johnson & Johnson (“J&J”) by largely completing sponsorship of NANORAY-312, which was initiated in the third quarter of 2024. Following this transition, Nanobiotix will evaluate and report interim data for NANORAY-312 as a result of the analysis of the most recent information. This process will occur in the first half of 2027, following the observation of the required number of events and the enrollment of the last patient.

Relevant forward-looking guidance will be communicated by J&J for NANORAY-312 and other JNJ-1900 (NBTXR3) related studies sponsored by J&J. Nanobiotix will continue to provide guidance regarding clinical development updates on JNJ-1900 (NBTXR3) as well as studies sponsored by Texas University MD Anderson Cancer Center.

JNJ-1900 (NBTXR3) is a potential oncology product containing functional hafnium oxide nanoparticles administered via a single intratumoral injection and activated by radiotherapy. The conceptual proof of the product was obtained from a successful randomized Phase 2/3 trial conducted on soft tissue sarcomas in 2018. The mechanism of action aims to induce significant tumor cell death within the injected tumor when activated by radiotherapy, while also triggering adaptive immune responses and creating long-term cancer memory. Considering the physical mechanism, Nanobiotix believes that JNJ-1900 (NBTXR3) could be scalable for all types of solid tumors eligible for radiotherapy.

Radiotherapy-activated JNJ-1900 (NBTXR3) is being evaluated in multiple solid tumor indications as a monotherapy or in combination therapy. The program is led by the global, randomized Phase 3 study NANORAY-312, conducted on locally advanced head and neck squamous cell carcinomas. In February 2020, the U.S. Food and Drug Administration granted fast track designation for the study of radiotherapy-activated JNJ-1900 (NBTXR3) with or without cetuximab. This applies to the patients assessed in the Phase 3 study.

Nanobiotix has adopted a collaboration strategy to broaden the development of the product candidate in parallel with prioritized development pathways. In line with this strategy, a comprehensive clinical research collaboration with Texas University MD Anderson Cancer Center was initiated in 2019, supporting several Phase 1 and Phase 2 studies evaluating JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a licensing agreement with Janssen Pharmaceutica NV, a subsidiary of Johnson & Johnson, for the global co-development and commercialization of JNJ-1900 (NBTXR3).

NANOBIOTIX was founded in 2003 and is headquartered in Paris, France. It has been trading on Euronext Paris since 2012 and on the Nasdaq Global Select Market since December 2020. The company has multiple subsidiaries in locations including Cambridge, Massachusetts.

Nanobiotix holds more than 25 umbrella patents related to three (3) nanotechnology platforms concerning oncology, bioavailability and biodistribution, and central nervous system disorders.