Nanobiotix announces new clinical data from NBTXR3 study

Nanobiotix announced new clinical data from a Phase 1 study evaluating radiotherapy-activated NBTXR3 for patients with pancreatic ductal adenocarcinoma, or PDAC. The study is being conducted as part of an ongoing collaboration between Nanobiotix and The University of Texas MD Anderson Cancer Center and results were presented at the American Association for Cancer Research, or AACR, 2023 Special Conference on Pancreatic Cancer. PDAC is an indication associated with poor prognosis and an increasing impact on cancer-related mortality worldwide. This Phase 1 study was designed with two parts: The dose-finding part with 1 patient at dose level 1 and 9 patients at dose level 2. The expansion part at the recommended phase 2 dose, or RP2D, with 12 additional patients. NBTXR3 was administered prior to radiotherapy, or RT, via an endoscopic ultrasound, or EUS-guided intratumoral injection. All patients received low-dose intensity-modulated radiation in 15 fractions, and were followed up to one year. Importantly, all patients in the study had previously received a four-month course of chemotherapy and showed no radiographic evidence of metastases at screening. The first patient at dose level 1 and subsequent 14 patients at dose level 2 had no injection complications. One patient at dose level 2 had 1 dose-limiting toxicity related to RT. As of the data cutoff, 13 patients were evaluable for efficacy. 11 patients had stable disease, or SD, 1 had progressive disease in the injected lesion, and 1 had a pathological complete response after surgery. Taken together, these results represent a 92.3% local disease control rate and a median Overall Survival of 21 months in evaluable patients. Notably, the patient who achieved pathological complete response entered the study with an unresectable tumor. The dose-finding part of the study is complete, establishing the RP2D at 42% of gross tumor volume, or GTV, and achieving the primary objective of the trial. The expansion part remains ongoing. The principal investigator concluded that these data suggest tolerable safety and promising early signs of anti-tumor efficacy. The company believes these results support the rationale for further development of NBTXR3 in pancreatic cancer.