Nanobiotix (NANO) Status Update summary

Background and unmet need

• Locally advanced or borderline resectable pancreatic cancer has a poor prognosis and high unmet need for improved outcomes.

• Pancreatic ductal adenocarcinoma is considered a 'cold tumor' with poor immune activity.

• Standard treatment includes chemotherapy followed by radiation if no metastasis occurs, but extending escalated dose radiotherapy is challenging due to dose limitations.

Study design and patient characteristics

• Phase I/II single-arm trial at MD Anderson evaluated NBTXR3 plus radiation in 22 patients, mostly with locally advanced disease, compared to historical controls from the same center.

• Patients received induction chemotherapy, then NBTXR3 intratumoral injection followed by moderate dose RT (45 Gy in 15 fractions), without concurrent chemotherapy.

• Most patients (91%) had locally advanced disease; median age was 62.5 years and 54.5% were female.

• Historical controls included 243 patients treated with standard of care, often with concurrent chemoradiation.

Safety and feasibility

• Safe injection of NBTXR3 was achieved in all patients via endoscopic ultrasound guidance.

• No dose-limiting toxicities were observed; recommended phase 2 dose is 42% of gross tumor volume.

• Three grade 3 adverse events occurred, only one possibly related to NBTXR3, all transient.