Nanobiotix announces regulatory harmonization, new patent for JNJ-1900

Nanobiotix (NBTX) announced two developments related to radioenhancer JNJ-1900, which is licensed by Janssen Pharmaceutica, a Johnson & Johnson (JNJ) company. Health authorities in major European countries have agreed to formally reclassify JNJ-1900 from a medical device to a drug, completing a process initiated by Johnson & Johnson to harmonize the product candidate’s regulatory status with classifications already in place in the United States and other major markets. The reclassification follows updated insights into the product candidate’s mechanism of action. In parallel, Nanobiotix has filed a new composition of matter patent for JNJ-1900 that aims to reinforce the intellectual property foundation supporting the product candidate. JNJ-1900 is currently the subject of a comprehensive global clinical development program across multiple tumor types and therapeutic combinations, including a pivotal Phase 3 trial in head and neck cancer.