Key insights
- The FDA accepted protocol changes to Nanobiotix's Phase 3 head and neck cancer study sponsored by Johnson & Johnson. The amendment eliminates an interim analysis, potentially accelerating the final analysis readout. This positive development could lead to milestone payments for Nanobiotix and suggests progress in the development of JNJ-1900, a novel cancer treatment. The impact on the broader US equity market is limited but incrementally positive for the healthcare sector.
Nanobiotix (NBTX) announced the FDA accepted a protocol amendment to its ongoing Phase 3 head and neck cancer study, according to a company statement.
The amendment, submitted by study sponsor Johnson & Johnson, eliminates a previously planned interim analysis and modifies the final analysis to include fewer events and be conducted sooner than originally planned.
The modified final analysis is expected to readout in the same timeframe as the previously planned interim analysis, though exact timing depends on when clinical events occur, the company stated.
The NANORAY-312 study evaluates JNJ-1900 (NBTXR3), a hafnium oxide nanoparticle treatment administered via intratumoral injection and activated by radiotherapy. The study focuses on patients with locally advanced head and neck squamous cell cancers.
Under its license agreement with Johnson & Johnson, Nanobiotix is eligible to receive aggregate payments in the next few years subject to achieving development and regulatory milestones for head and neck cancer and lung cancer programs.
The FDA granted Fast Track designation for JNJ-1900 in February 2020 for patients with locally advanced head and neck squamous cell carcinoma who are not eligible for platinum-based chemotherapy.
Nanobiotix, founded in 2003 and headquartered in Paris, trades on Euronext Paris and NASDAQ. The biotechnology company focuses on physics-based therapeutic approaches and holds more than 25 patents across three nanotechnology platforms.