Nanobiotix Announces Completion of Phase 1 Dose Escalation and NBTXR3 Recommended Phase 2 Dose for the Treatment of Inoperable, Recurrent Lung Cancer in Patients Amenable to Re-Irradiation - Seite 2

The completed dose escalation part of Study 2020-0123 established the recommended Phase 2 dose after determination of injection feasibility and observation of a favorable safety profile. The expansion part of the study, further evaluating safety and early signals of efficacy, is ongoing.

About MD ANDERSON STUDY 2020-0123
MD Anderson Study 2020-0123 (NCT04505267) is a Phase 1 study evaluating the best dose and observing the adverse effects of NBTXR3 activated by radiation therapy (“RT”) for the treatment of non-small cell lung cancer (“NSCLC”) that cannot be treated with surgery (“inoperable”), and has come back (“recurrent”), in patients who have previously been treated with definitive RT. The primary objectives of the study include a safety assessment of re-irradiation in these patients and determination of the recommended Phase 2 dose of NBTXR3 activated by RT. The re-irradiation safety assessment part and the dose-finding part of the study have completed. An expansion part evaluating additional signals of safety, feasibility, anti-tumor response, and time-to-event outcomes is ongoing.

About NBTXR3
NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas for which the product received a European CE mark in 2019. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.
        
Radiotherapy-activated NBTXR3 is being evaluated across multiple solid tumor indications as a single agent or in combination with anti-PD-1 immune checkpoint inhibitors, including in NANORAY-312—a global, randomized phase III study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the phase III study.