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.
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