NANOBIOTIX Announces Updates to JNJ-1900 (NBTXR3) Clinical Program Following Transfer of Ongoing Phase 3 Head and Neck Cancer Trial Sponsorship and Operational Control

Core Insights - Nanobiotix has announced updates to the clinical development program for JNJ-1900 (NBTXR3), a late-stage clinical biotechnology product aimed at expanding treatment options for cancer patients [1][2]. Group 1: Clinical Development Updates - The transfer of NANORAY-312 sponsorship to Johnson & Johnson has been completed, along with the operational control of the Phase 3 clinical trial [2]. - Nanobiotix estimates that interim data for NANORAY-312 will be analyzed and reported in the first half of 2027, following the observation of the requisite number of events and recruitment of the last patient [2]. - Future guidance related to NANORAY-312 and other JNJ-1900 (NBTXR3)-related studies will be communicated by Johnson & Johnson, while Nanobiotix will continue to provide updates on its sponsored studies [3]. Group 2: Product Overview - JNJ-1900 (NBTXR3) is a novel oncology product utilizing functionalized hafnium oxide nanoparticles, administered via a one-time intratumoral injection and activated by radiotherapy [4]. - The product's mechanism of action is designed to induce significant tumor cell death in the injected tumor, triggering an adaptive immune response and long-term anti-cancer memory [4]. - The product is being evaluated across multiple solid tumor indications, with a focus on locally advanced head and neck squamous cell cancers in the NANORAY-312 Phase 3 study [5]. Group 3: Strategic Collaborations - Nanobiotix has engaged in a collaboration strategy to expand the development of JNJ-1900 (NBTXR3), including a comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center [6]. - In 2023, a license agreement was announced for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a subsidiary of Johnson & Johnson [6]. Group 4: Company Background - Nanobiotix is a late-stage clinical biotechnology company founded in 2003, headquartered in Paris, France, and listed on Euronext Paris and Nasdaq [8]. - The company holds over 25 umbrella patents associated with three nanotechnology platforms, focusing on oncology, bioavailability, and disorders of the central nervous system [9].