NANOBIOTIX Announces Positive Results for JNJ-1900 in Recurrent Non-Small Cell Lung Cancer

NANOBIOTIX, a late-stage clinical biotechnology company, has announced the completion of its full cohort Phase 1 results for JNJ-1900 (NBTXR3) in the treatment of inoperable, recurrent non-small cell lung cancer (NSCLC). The study, sponsored by The University of Texas MD Anderson Cancer Center, evaluated the use of radiotherapy-activated JNJ-1900 (NBTXR3) for patients who are candidates for re-irradiation.

All 24 patients enrolled in the study completed treatment without experiencing dose-limiting toxicities. The study also reported no Grade 3 or higher adverse events related to JNJ-1900 (NBTXR3) or the injection procedure. One-year locoregional control was achieved in 79% of evaluable subjects, with a one-year local progression-free survival (LPFS) rate of 61% and a one-year overall survival (OS) rate of 70%.

According to the study's principal investigator, Saumil Gandhi, MD, PhD, from the Department of Thoracic Radiation Oncology at UT MD Anderson, the findings suggest that JNJ-1900 (NBTXR3) may permit clinically meaningful local control using a substantially lower re-irradiation dose than previously used. "The normal tissue near the tumor has already received a full course of radiation, so the dose that can be delivered safely during a second course is limited. Additionally, the disease that returns is often more radioresistant because it survived radiation the first time. In this study, JNJ-1900 (NBTXR3) was delivered without dose-limiting toxicities, and we observed clinically meaningful local control at a substantially lower re-irradiation dose."

The study, presented at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer, showed that the recommended Phase 2 dose was established at 33% of the gross tumor volume. At a median follow-up of 12 months (data cutoff: August 2026), the one-year locoregional control rate was 79%, one-year local progression-free survival was 61% (median 13.6 months), and one-year overall survival was 70% (median 14.8 months).

Louis Kayitalire, MD, Chief Medical Officer of NANOBIOTIX, expressed encouragement over the full-cohort findings.

Enrollment in both the dose-escalation and expansion parts of the study is complete per protocol. Following the encouraging findings, additional patient enrollment in this study is planned. JNJ-1900 (NBTXR3) is a novel, potentially first-in-class 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 an adaptive immune response and long-term anti-cancer memory.

NANOBIOTIX is a late-stage clinical biotechnology company pioneering disruptive, physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients. The company's philosophy is rooted in the concept of pushing past the boundaries of what is known to expand possibilities for human life. Incorporated in 2003, NANOBIOTIX is headquartered in Paris, France, and is listed on Euronext Paris and the Nasdaq Global Select Market.