• Established recommended Phase 2 dose of NBTXR3 for the treatment of patients with inoperable, recurrent non-small cell lung cancer ("NSCLC") who have previously received definitive radiation therapy
• Confirmation of injection feasibility and favorable safety profile in completed Phase 1 dose escalation part of the study support potential for later stage development of NBTXR3 for the treatment of patients with inoperable, recurrent NSCLC who are amenable to re-irradiation
• The dose expansion part of the Phase 1 study designed to further assess safety and evaluate early signals of efficacy is ongoing

PARIS and CAMBRIDGE, Mass., April 02, 2024 (GLOBE NEWSWIRE) -- NANOBIOTIX (NASDAQ:NBTX), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today 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 ("NSCLC") that cannot be treated by surgery ("inoperable"), and has come back ("recurrent"), whom have previously been treated with definitive radiation therapy and are amenable to re-irradiation. The Phase 1 study ("Study 2020-0123") is being conducted by The University of Texas MD Anderson Cancer Center ("MD Anderson") as part of an ongoing strategic collaboration with Nanobiotix.

"NBTXR3 is designed as a product candidate with the potential to improve treatment outcomes for patients with cancer in any setting where radiotherapy is a part of the treatment regimen. 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, MD, Chief Medical Officer at Nanobiotix. "We believe the injection feasibility and favorable safety profile we have observed from the completed dose escalation part of this Phase 1 lung cancer study could pave the way for additional clinical development of NBTXR3 for patients with inoperable, recurrent lung cancer and patients amenable to re-irradiation."

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.