NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX), a leader in the field of biotechnology, announced a significant achievement in its ongoing pivotal Phase 3 study, NANORAY-312. The study, which is evaluating the potential first-in-class radioenhancer NBTXR3 for elderly patients with head and neck cancer, has met operational requirements, resulting in a $20 million milestone payment from strategic partner Janssen Pharmaceutica NV, part of the Johnson & Johnson family of companies.

Laurent Levy, Nanobiotix co-founder and chairman of the executive board, expressed optimism about the progress: “This first milestone payment related to our ongoing pivotal Phase 3 study evaluating NBTXR3 for patients with head and neck cancer represents another step forward in our pathway to bring NBTXR3 to registration.” Levy’s statement underscores the collaborative efforts with Janssen to make significant contributions to global patient care.

This $20 million milestone is part of the global licensing agreement between Nanobiotix and Janssen, detailed in a press release dated 4 December 2023. NBTXR3, a novel oncology product, consists of functionalized hafnium oxide nanoparticles, administered through intratumoral injection and activated by radiotherapy. Its innovative physical mechanism of action (MoA) is designed to induce significant tumor cell death and trigger an adaptive immune response.

The promising potential of NBTXR3 was first demonstrated in soft tissue sarcomas, leading to its European CE mark approval in 2019. Nanobiotix believes that due to its physical MoA, NBTXR3 could be scalable across various solid tumors and therapeutic combinations, particularly with immune checkpoint inhibitors.

The United States Food and Drug Administration granted Fast Track designation in February 2020 for NBTXR3 activated by radiation therapy, targeting the same patient population as in the NANORAY-312 study. Additionally, Nanobiotix’s collaboration strategy, including its partnership with The University of Texas MD Anderson Cancer Center, aims to expand NBTXR3’s development across multiple tumor types and therapeutic combinations.

Nanobiotix’s achievement in receiving a $20M milestone from Janssen is a testament to the potential of NBTXR3 in transforming cancer treatment. This collaboration exemplifies how strategic partnerships in the biotech sector can accelerate the development and accessibility of innovative treatments. NBTXR3’s unique approach in enhancing radiotherapy’s efficacy presents a promising avenue in oncology, potentially improving outcomes for patients with challenging cancer types, like head and neck cancer.

  Janssen Pharmaceutica, Johnson & Johnson, Laurent Levy, Nanobiotix, NBTXR3, Oncology, Radioenhancer Technology