Nanobiotix announced two significant regulatory and intellectual property developments for its potential first-in-class radioenhancer JNJ-1900 (NBTXR3), which is licensed by Janssen Pharmaceutica NV, a Johnson & Johnson company. The developments aim to reinforce the global positioning of the cancer treatment candidate currently in late-stage clinical development.
European Regulatory Harmonization Achieved
Health authorities in major European countries have formally agreed to reclassify JNJ-1900 (NBTXR3) from a medical device to a medicinal product, completing a harmonization process initiated by Johnson & Johnson. This reclassification aligns the product candidate's regulatory status with classifications already established in the United States and other major markets.
The reclassification follows updated insights into the product candidate's mechanism of action and supports unified global regulatory classification, facilitating future global strategies and regulatory filings.
"These updates reflect our continued commitment to the JNJ-1900 (NBTXR3) program," said Laurent Levy, co-founder and chairman of the executive board at Nanobiotix. "We are pleased with the progress achieved with health authorities and proud to continue advancing this potential first-in-class product candidate toward patients in need."
Intellectual Property Strengthened with New Patent
In parallel with the regulatory harmonization, Nanobiotix has filed a new composition of matter patent for JNJ-1900 (NBTXR3) to reinforce the intellectual property foundation supporting the product candidate. This addition to the company's patent portfolio aims to strengthen protection for the novel radioenhancer technology.
Novel Mechanism of Action and Clinical Development
JNJ-1900 (NBTXR3) is a novel oncology product composed of functionalized hafnium oxide nanoparticles administered via one-time intratumoral injection and activated by radiotherapy. The product candidate's mechanism of action is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory.
The radioenhancer achieved proof-of-concept in soft tissue sarcomas through a successful randomized Phase 2/3 study completed in 2018. Given its physical mechanism of action, Nanobiotix believes JNJ-1900 (NBTXR3) could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.
Comprehensive Clinical Program Underway
JNJ-1900 (NBTXR3) is currently the subject of a comprehensive global clinical development program across multiple tumor types and therapeutic combinations. The program is led by NANORAY-312, a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers.
In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of JNJ-1900 (NBTXR3) activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced head and neck squamous cell carcinoma who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.
Strategic Collaborations Support Development
Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. In 2019, the company entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and Phase 2 studies evaluating JNJ-1900 (NBTXR3) across tumor types and therapeutic combinations.
In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company, further advancing the product candidate's development and commercial potential.
