NEW BRUNSWICK (dpa-AFX) - Nanobiotix S.A. (NBTX), a biotechnology company focused on nanoparticle-based cancer treatments, announced Monday positive full results from the completed dose escalation and dose expansion phases of a Phase 1 study evaluating JNJ-1900 (NBTXR3) in patients with locally advanced or borderline resectable pancreatic cancer or PC.
The results demonstrated favorable safety, injection feasibility, and encouraging oncologic outcomes in patients with locally advanced or borderline resectable PC.
Based on the safety and preliminary efficacy findings, investigators concluded that further evaluation of JNJ-1900 (NBTXR3) is warranted in a randomized study.
Nanobiotix is in a license deal for the global co-development and commercialization of JNJ-1900 (NBTXR3) with Janssen Pharmaceutica NV, a Johnson & Johnson company.
JNJ-1900 (NBTXR3) is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered through one-time intratumoral injection and activated by radiotherapy.
The Phase 1 study, conducted by The University of Texas MD Anderson Cancer Center, evaluated the potential of radiotherapy(RT)-activated JNJ-1900 (NBTXR3) activated by radiation therapy to overcome inherent radioresistance in patients with locally advanced (LAPC) or borderline resectable (BRPC) disease.
The majority of patients in the study were diagnosed with locally advanced, unresectable disease (LAPC). Patients with LAPC or BRPC are traditionally treated with induction chemotherapy followed by concurrent chemoradiation. In the Phase 1 study, the treatment regimen in the completed dose escalation and dose expansion parts replaced concurrent chemoradiation with RT-activated JNJ-1900 (NBTXR3) after induction chemotherapy.
The results were presented at the 2025 Annual Meeting of the European Society for Radiotherapy and Oncology or ESTRO 2025.
MD Anderson received FDA clearance to expand the study to include a new cohort that combines of JNJ-1900 (NBTXR3) with SOC concurrent chemoradiation after induction chemotherapy. The first patient in the new cohort has been injected, and recruitment is ongoing.
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