Nanobiotix Completes Transfer of Clinical Trial to Johnson & Johnson
Nanobiotix has announced the completion of the clinical trial sponsorship transfer of NANORAY-312 to Johnson & Johnson, according to a statement released by the company.
Clinical Development Program Transfer
The clinical development program of JNJ-1900 (NBTXR3), currently in an advanced phase, has recently had its sponsorship transferred from Nanobiotix to Johnson & Johnson. This transfer was initiated in the third quarter of 2024 across the major geographical regions of the study. The full operational control transition of the Phase 3 clinical trial is now finalized, according to Nanobiotix's statement. An interim analysis of NANORAY-312 is scheduled after the recruitment of the last patient and the observation of the required number of events, with results expected in the first half of 2027. Johnson & Johnson will henceforth communicate estimates related to this program and other studies it sponsors.
Product Evaluation in Oncology
The product JNJ-1900 (NBTXR3), consisting of functionalized hafnium oxide nanoparticles, is currently being evaluated for its potential in oncology. Administered via a single intra-tumoral injection and activated by radiotherapy, this product aims to induce tumor cell death and an adaptive immune response. A positive Phase 2/3 trial was already conducted in 2018 for soft tissue sarcomas. The most advanced program is the NANORAY-312 study, a Phase 3 trial concerning locally advanced squamous cell carcinomas of the head and neck. In 2020, the U.S. FDA granted Fast Track designation for this radiotherapy-activated product, with or without cetuximab.
Development Strategy and Collaborations
As part of its development strategy, Nanobiotix has established a collaboration with the MD Anderson Cancer Center at the University of Texas to evaluate JNJ-1900 in various types of tumors and therapeutic combinations. In 2023, the company entered into a licensing agreement with Janssen Pharmaceutica NV to co-develop and commercialize JNJ-1900. Founded in 2003 and based in Paris, Nanobiotix develops innovative cancer treatments using nanotechnology. The company has been listed on Euronext Paris and the Nasdaq since 2012 and 2020, respectively.
