Nanobiotix Concludes Phase 1 Dose Escalation, Determines Phase 2 Dose for NBTXR3 in Re-Irradiation-Eligible Recurrent Lung Cancer

April 2, 2024 — NANOBIOTIX, a late-clinical stage biotechnology company, has completed the dose escalation phase of a Phase 1 study evaluating NBTXR3, a potential first-in-class radioenhancer, for patients with inoperable, recurrent non-small cell lung cancer (NSCLC) who have previously received definitive radiation therapy. The study, conducted by The University of Texas MD Anderson Cancer Center, established the recommended Phase 2 dose of NBTXR3 and confirmed the injection's feasibility and favorable safety profile, indicating potential for later stage development.
The dose expansion part of the Phase 1 study is currently ongoing to further assess the safety and evaluate early signals of efficacy. NBTXR3 is composed of functionalized hafnium oxide nanoparticles administered via one-time intratumoral injection and activated by radiotherapy. It has shown potential to induce significant tumor cell death when activated by radiotherapy and trigger an adaptive immune response.
The primary objectives of the study include assessing the safety of re-irradiation in patients with inoperable, recurrent NSCLC and determining the recommended Phase 2 dose of NBTXR3. The re-irradiation safety assessment and dose-finding parts of the study have been completed, with an expansion part evaluating additional signals of safety, feasibility, anti-tumor response, and time-to-event outcomes currently in progress.
NBTXR3 has received a European CE mark for the treatment of patients with soft tissue sarcoma and is being evaluated across multiple solid tumor indications, both as a single agent and in combination with anti-PD-1 immune checkpoint inhibitors. NANOBIOTIX is a clinical biotechnology company focused on pioneering physics-based therapeutic approaches to improve treatment outcomes for cancer patients. The company's lead product candidate, NBTXR3, has achieved market authorization in Europe under the brand name Hensify®.

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