The French biotech company Nanobiotix announced today that it has dosed the first patient in the CONVERGE study, a Phase 2 randomized controlled clinical trial evaluating its potentially first-in-class radiotherapy-activated nanoparticle candidate, JNJ-1900 (NBTXR3).
Sponsored by Janssen Pharmaceutica, the trial will study the therapy in patients with Stage 3 unresectable non-small cell lung cancer, who are receiving chemoradiation and consolidation immunotherapy with AstraZeneca’s durvalumab (Imfinzi).
NBTXR3 is composed of specific nanoparticles called functionalized hafnium oxide nanoparticles. When NBTXR3 is injected into the tumor and activated via radiotherapy, it causes significant tumor cell death. This, in turn, triggers an adaptive immune response and long-term anti-cancer memory in the immune system.
While the CONVERGE study focuses on Stage 3 unresectable non-small cell lung cancer, Nanobiotix is also studying NBTXR3 across other solid tumor indications, either as a single therapy or in combination with anti-PD-1 immune checkpoint inhibitors. For example, in NANORAY-312, a global randomized Phase 3 study, evaluating NBTXR3 in locally advanced head and neck squamous cell cancers.
“We believe the true value of JNJ-1900 (NBTXR3) is driven by its potential to address the unmet needs of the millions of patients each year who receive radiotherapy as part of their treatment,” explained Laurent Levy, CEO of Nanobiotix and Chairman of the Executive Board, in a press release.
“With a clear path to potential registration in head and neck cancer established through NANORAY-312, the first patient dosed in the CONVERGE study in non-small cell lung cancer brings us another step closer to delivering for the large number of patients JNJ-1900 (NBTXR3) is designed to serve.”
NBTXR3 activated by radiation therapy was granted regulatory Fast Track designation by the FDA in February 2020. Nanobiotix and Janssen Pharmaceutica entered into a global co-development and commercialization license agreement for NBTXR3 in July 2023.
