Nanobiotix S.A. announced completion of the dose escalation part of a Phase 1 study evaluating potential first-in-class radioenhancer NBTXR3 for patients with non-small cell lung cancer that cannot be treated by surgery (NCT04505267) is being conducted by The University of Texas MD Anderson Cancer Center as part of an ongoing strategic collaboration with Nanobiotix. While these patients experience different cancer types and are each faced with unique challenges, what they share is an urgent need for therapeutic innovation with the chance to make a difference," said Louis Kayitalire, Chief Medical Officer at Nanobiotix. 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. 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 been treated with surgery (Inoperable"), and has come back (" recurrent"), in patients who have previously been treated with definitive radiation therapy and are amenable to re-irradiation. The completed dose expansion part of the Phase 1 study ("Study 2020-0123") is being conducted by The Universityof Texas MD Anderson Cancer Center ("MSCLC") as part of an ongoing Strategic collaboration with Nanobiotix".

The completed dose escalation part of study 2020-0123 (N CT04505267) is a Phase 1 study evaluating The best dose and observed the adverse effects of NBT XR3 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 already 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 activation 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. Radadiotherapy-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 activate by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who have previously advanced HNSCC who are am enable to re-irradiation and the dose-finding part the study have completed.

The dose expansion part of the Phase 2 study designed to further assess safety and early signals of efficacy is ongoing.