Nanobiotix(US:NBTX) globenewswire.comยท2024-05-21 20:15Core Insights - Nanobiotix is advancing its corporate strategy to enable long-term growth, focusing on the co-development and commercialization of its lead therapeutic candidate NBTXR3, a nanoparticle-based radioenhancer for cancer treatment [1][3][11] Development of NBTXR3 - NBTXR3 is being developed in collaboration with Janssen Pharmaceutica NV, aiming to leverage expected sustainable revenue from its commercialization to support further development of additional nanoparticle therapy platforms [2][11] - The current development program includes a pivotal Phase 3 study (NANORAY-312) for elderly patients with locally advanced head and neck cancer and a Phase 2 study for stage 3 non-small cell lung cancer (NSCLC) [5][13] Regulatory and Operational Updates - Nanobiotix and Janssen have aligned to transfer the global sponsorship of the NANORAY-312 trial, with ongoing support from Nanobiotix during the transition [6][9] - A protocol amendment has been made to remove the planned futility analysis for NANORAY-312, based on positive data from a related Phase 1 study [7][8] - The FDA has granted a "Study May Proceed" letter for the Phase 2 NSCLC study, indicating regulatory support for the ongoing research [9][11] Financial and Strategic Collaborations - The collaboration with Janssen has resulted in a $20 million milestone payment to Nanobiotix following the achievement of the first operational milestone in NANORAY-312 [12] - Nanobiotix is exploring options to extend its cash runway beyond the current expectation of Q3 2025, indicating proactive financial management [10][11] Future Directions - The company plans to provide updates on its development plans for NBTXR3 and other nanoparticle-based therapies in the second half of 2024 [19] - Nanobiotix is also focusing on expanding its nanoparticle therapy platforms, including Curadigm and OOcuity, to enhance treatment outcomes in various healthcare settings [16][17][18]