NANOBIOTIX Announces Regulatory Harmonization and New Composition of Matter Patent Filed for JNJ-1900 (NBTXR3)

Core Insights - Nanobiotix announced significant developments regarding JNJ-1900 (NBTXR3), a potential first-in-class radioenhancer for cancer treatment, which is licensed by Janssen Pharmaceutica NV, a Johnson & Johnson company [1][4] Regulatory Developments - Health authorities in major European countries have reclassified JNJ-1900 (NBTXR3) from a medical device to a drug, aligning its regulatory status with that in the United States and other major markets [2][9] - This reclassification supports a unified global regulatory classification, facilitating future global strategies and filings [9] Intellectual Property - Nanobiotix has filed a new composition of matter patent for JNJ-1900 (NBTXR3) to strengthen the intellectual property foundation supporting the product candidate [3][9] Clinical Development - JNJ-1900 (NBTXR3) is undergoing a comprehensive global clinical development program across multiple tumor types, including a pivotal Phase 3 trial in head and neck cancer [4][6] - The product candidate has shown proof-of-concept in soft tissue sarcomas through a successful randomized Phase 2/3 study in 2018 [5] Mechanism of Action - JNJ-1900 (NBTXR3) consists of functionalized hafnium oxide nanoparticles, administered via one-time intratumoral injection and activated by radiotherapy, designed to induce significant tumor cell death and trigger an adaptive immune response [5] Collaboration and Strategy - Nanobiotix has engaged in a collaboration strategy to expand the development of JNJ-1900 (NBTXR3), including a partnership with The University of Texas MD Anderson Cancer Center for several Phase 1 and Phase 2 studies [7]