Nanobiotix Reports Promising Early Data from Phase 2 Lung Cancer Trial of JNJ-1900 Radioenhancer
核心洞察
Nanobiotix announced first data from the CONVERGE Phase 2 trial evaluating JNJ-1900 (NBTXR3) in stage 3 inoperable non-small cell lung cancer, showing a 71.4% objective response rate compared to an estimated benchmark of 45-50%.
The novel hafnium oxide nanoparticle radioenhancer demonstrated an acceptable safety profile with no serious treatment-emergent adverse events and 100% disease control rate in the initial seven patients evaluated.
The company strengthened its financial position through a $71 million royalty financing agreement with HealthCare Royalty (搜索), extending its cash runway into early 2028 while advancing multiple clinical programs across solid tumor types.
Nanobiotix announced promising early results from the CONVERGE study, a Johnson & Johnson-sponsored randomized Phase 2 clinical trial evaluating the potential first-in-class radioenhancer JNJ-1900 (NBTXR3) in patients with stage 3 inoperable non-small cell lung cancer. The data, presented at the 2026 European Lung Cancer Conference, showed encouraging efficacy signals that exceeded expected benchmarks.
Early Efficacy Results Exceed Expectations
The initial efficacy responses observed in seven patients at first disease evaluation following concurrent chemoradiotherapy, and before treatment with anti-PD-L1 (搜索) therapy, demonstrated an objective response rate (ORR) of 71.4% and disease control rate (DCR) of 100%. These results compare favorably to the estimated benchmark ORR of 45-50% for this patient population.
The procedure demonstrated an acceptable safety profile without serious treatment-emergent adverse events and did not adversely impact patients' ability to continue planned therapy. The first patient in the CONVERGE study was dosed in the first quarter of 2025.
Mechanism and Broad Therapeutic Potential
JNJ-1900 (NBTXR3) is composed of functionalized hafnium oxide nanoparticles administered via one-time intratumoral injection and activated by radiotherapy. The product candidate's mechanism of action is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory.
Given its physical mechanism of action, Nanobiotix believes JNJ-1900 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors. The product achieved proof-of-concept in soft tissue sarcomas through a successful randomized Phase 2/3 study in 2018.
Comprehensive Clinical Development Program
The global development program for JNJ-1900 is led by NANORAY-312, a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. In February 2020, the FDA granted Fast Track designation for the investigation of JNJ-1900 activated by radiation therapy, with or without cetuximab, for patients with locally advanced head and neck squamous cell carcinoma who are not eligible for platinum-based chemotherapy.
Multiple early-stage studies across solid tumor types continued to progress throughout 2025, demonstrating the broad potential of the radioenhancer technology:
Non-Small Cell Lung Cancer Re-irradiation
A Phase 1 study sponsored by MD Anderson showed favorable safety profile and early efficacy signals, with 12-month local progression-free survival of 64% and 12-month overall survival of 83% in 12 patients.
Pancreatic Cancer
Updated data from a Phase 1 study in locally advanced or borderline resectable pancreatic cancer showed favorable safety, injection feasibility, and encouraging oncologic outcomes with median overall survival of 23 months from date of diagnosis in 22 patients.
Esophageal Cancer
First data on JNJ-1900 activated by photon or proton chemoradiation showed 85% disease control rate and 69% objective response rate, including six complete responses and three partial responses, in 13 patients with locally advanced adenocarcinoma of the esophagus.
Head and Neck Cancer
Updated data from 103 heavily pre-treated patients with recurrent and/or metastatic head and neck cancer showed treatment remained well-tolerated with consistent injection feasibility. The study demonstrated 63% disease control rate and 37% objective response rate in anti-PD-1 (搜索) naïve patients, and 74% disease control rate and 32% objective response rate in anti-PD-1 resistant patients.
Strategic Partnership and Financial Strengthening
In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of JNJ-1900 with Janssen Pharmaceutica NV, a Johnson & Johnson company. An amendment to this licensing agreement in the first quarter of 2025 removed the vast majority of Nanobiotix's funding obligation for NANORAY-312, safeguarding the company's path to sustainable cash flow through hundreds of millions in potential milestone payments.
The company strengthened its financial position through a strategic non-dilutive royalty monetization agreement with HealthCare Royalty (搜索) for up to $71 million in the fourth quarter of 2025, with $50 million already received. This financing extended the company's cash runway into early 2028, assuming receipt of the remaining $21 million funding expected one year post-closing upon reaching certain conditions.
Next-Generation Platform Development
Beyond the radioenhancer platform, Nanobiotix advanced its Curadigm Nanoprimer platform with four new patent applications filed, new in vivo data presentations, and the launch of Chemistry, Manufacturing, and Controls activities to support both internal pipeline and external collaborations. The company presented new in vivo pre-clinical data evaluating the Nanoprimer in combination with therapeutic vaccines that could serve as the foundation for an initial internal proprietary pipeline.
Financial Performance and Outlook
For the year ended December 31, 2025, Nanobiotix reported revenues and other income of €32.6 million, compared to negative €7.2 million in 2024. This included a one-off positive revenue recognition impact of €21.8 million related to the amended licensing agreement with Janssen. Research and development expenses decreased 43% year-over-year to €23.1 million, primarily reflecting the removal of funding obligations on the NANORAY-312 study.
Net loss attributable to shareholders was €24.0 million, or €0.50 per share, for 2025, a 65% decrease year-over-year. As of December 31, 2025, the company had €52.8 million in cash and cash equivalents.
Clinical data readouts are expected in 2026 from Phase 1 and 2 studies in non-small cell lung cancer re-irradiation, pancreatic cancer, melanoma, and esophageal cancer, providing multiple opportunities to further validate the broad therapeutic potential of the radioenhancer technology across solid tumor types.