Nanobiotix Establishes Recommended Dose For Registrational Study Of Head & Neck Combo Therapy Trial

• Nanobiotix (NASDAQ: NBTX) determined the recommended phase 2 dose (RP2D) of the NBTXR3 combo regime for inoperable locoregional recurrent or recurrent and metastatic head and neck squamous cell carcinoma that is resistant to prior immunotherapy.

• The combo includes NBTXR3 plus Merck & Co Inc's (NYSE: MRK) Keytruda pembrolizumab or Bristol Myers Squibb Co's (NYSE: BMY) Opdivo (nivolumab).

• The combined dose escalation and dose expansion parts of Study 1100 are expected to enroll up to 141 patients.

• Related: Nanobiotix's Radiotherapy Combo Therapy Shows Boosted Anti-Tumor Activity In Preclinical Studies.

• The complete dose escalation part enrolled 29 patients in three cohorts. Based on the study's results, the RP2D for all three cohorts was determined to be 33% of gross tumor volume.

• Nanobiotix has amended the ongoing expansion phase of Study 1100. The amended dose expansion part also has three cohorts. However, the cohorts have been re-designed further to explore NBTXR3 plus anti-PD-1 in several immunotherapy-eligible indications, focusing on patients that are either naïve or resistant to prior immunotherapy.

• The company expects to provide updated clinical data from Study 1100 in Q4 2022. The registrational phase 3 protocol submission is expected in Q1 2023, followed by modification of the study design.

• Price Action: NBTX shares closed at $4.04 on Wednesday.

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