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

Nanobiotix 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 MRK Keytruda pembrolizumab or Bristol Myers Squibb Co's 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.