Nanobiotix presents data from JNJ-1900 dose escalation, expansion study cohorts

Nanobiotix (NBTX) announced first data from cohorts 1 and 2 of the dose escalation part of a Phase 1 dose escalation and dose expansion study evaluating JNJ-1900 combined with photon chemoradiation or proton chemoradiation followed by surgery, if medically indicated, for patients with locally advanced adenocarcinoma of the esophagus. The study results were presented at the 2025 annual meeting of the American Society for Radiation Oncology. Treatment was well-tolerated and feasible in the study population: feasibility of endoscopic ultrasound-guided intratumoral injection was confirmed in nine EADC patients with treated JNJ-1900 combined with photon CRT in cohort 1 and 4 EADC patients treated with JNJ-1900 combined with proton CRT in cohort 2; the recommended Phase 2 dose for JNJ-1900 combined with photon CRT was established at 33% of gross tumor volume. In total, 13 patients experienced treatment-emergent adverse events of any grade related to the overall treatment. Of which, 6 patients experienced TEAEs of any grade related to JNJ-1900 and 2 patients experienced TEAEs of any grade related to the injection procedure. Of these patients, 2 experienced grade 3+ TEAEs related to JNJ-1900 and 0 experienced grade 3+ TEAEs related to the injection procedure. No periprocedural or delayed adverse events were observed. Initial clinical response and outcomes were: 85% disease control rate; 69% objective response rate, including 6 biopsy-confirmed complete responses and 3 partial responses; 6 patients in the study were medically indicated for and underwent surgery after treatment with CRT and JNJ-1900; 2 of these patients had pathological complete response and 4 of these patients had major pathologic response. This evaluation in locally advanced esophageal cancer could potentially open a new indication for JNJ-1900 and provide support for the investigational radioenhancer in combination with proton radiation therapy as an additional activation modality beyond standard radiation therapy. Recruitment for dose escalation cohort 1 is complete. Five additional patients are being recruited for dose escalation cohort 2, which will be followed by recruitment of 12 additional patients for the dose expansion part of the study. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of JNJ-1900 with Janssen Pharmaceutica NV, a Johnson & Johnson (JNJ) company.