On December 26, 2023 NANOBIOTIX (Euronext : NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported that partner LianBio has entered into an agreement with Janssen Pharmaceutica NV ("Janssen"), a Johnson & Johnson company, whereby LianBio has assigned to Janssen LianBio’s exclusive rights to develop and commercialize potential first-in-class radioenhancer NBTXR3 in China, South Korea, Singapore, and Thailand (Press release, Nanobiotix, DEC 26, 2023, View Source [SID1234638796]).
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"Our collaboration strategy for the development and commercialization of NBTXR3 is rooted in a shared commitment to delivering the potential first-in-class radioenhancer to millions of patients around the world," said Laurent Levy, Nanobiotix co-founder and chairman of the executive board. "LianBio has served as an important partner in expanding our clinical development program in Asia, particularly with their support for our ongoing pivotal phase 3 study evaluating NBTXR3 in head and neck cancer. We look forward to continued momentum in our program and moving NBTXR3 toward global registration."
This agreement consolidates global development and commercialization rights of NBTXR3 with Janssen; streamlines the global alliance for co-development and registration of the radioenhancer with Nanobiotix; and includes all previously agreed upon economic terms between Nanobiotix and LianBio, including the Nanobiotix entitlement to receive up to an aggregate $220 million in potential contingent, development and commercialization milestone payments (less $15 million already paid to Nanobiotix by LianBio) along with tiered, low double-digit royalties based on net sales of NBTXR3 in Asian territories.
Following the deal close, LianBio will support the transition of the asset to Janssen for a period no longer than six months.
About NBTXR3
NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas for which the product received a European CE mark in 2019. The product candidate’s physical mechanism of action (MoA) 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 the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.
Radiotherapy-activated NBTXR3 is being evaluated across multiple solid tumor indications as a single agent or in combination with anti-PD-1 immune checkpoint inhibitors, including in NANORAY-312—a global, randomized phase III study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the phase III study.
Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several phase I and phase II studies evaluating NBTXR3 across tumor types and therapeutic combinations. In 2023 Nanobiotix announced a license agreement for the global co-development and commercialization of NBTXR3 with Janssen Pharmaceutica NV.