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On July 10, Nanobiotix announced that it had reached a collaboration with Johnson & Johnson, granting the latter global licensing rights for the co-development and commercialization of NBTXR3.
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According to the terms of the agreement, Nanobiotix will maintain operational control over the Phase III NANORAY-312 study of NBTXR3 for the treatment of squamous cell carcinoma of the head and neck, as well as all other ongoing studies, and the manufacturing, clinical supply, and initial commercial supply of NBTXR3. Johnson & Johnson will take full responsibility for evaluating the initial Phase II study of NBTXR3 in patients with Stage III lung cancer and will have the right to oversee the studies currently led by Nanobiotix.
Nanobiotix will receive $60 million in cash and operational support, a $30 million equity investment, up to $1.8 billion in development, regulatory, and sales milestone payments, as well as double-digit royalties based on product sales. Additionally, Johnson & Johnson has the option to independently develop five new indications with potential milestone payments of up to $650 million, and for each indication co-developed with Nanobiotix, the potential milestone payment could reach $220 million.
NBTXR3 is a novel, potentially first-in-class anticancer agent composed of functionalized hafnium oxide (HfO2) nanoparticles. It is administered via a single intratumoral injection and activated by radiotherapy. The physical mechanism of action (MoA) of the candidate product aims to induce extensive tumor cell death within the injected tumor upon activation by radiotherapy, subsequently triggering an adaptive immune response and long-term anticancer memory.
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Source: Nanobiotix Official Website
Thanks to this physical mechanism of action, Nanobiotix believes that NBTXR3 can be extended to any solid tumor treatable with radiotherapy and any combination therapy, particularly in combination with immune checkpoint inhibitors. In February 2020, the U.S. FDA granted Fast Track designation for the evaluation of radiotherapy-activated NBTXR3 in the NANORAY-312 trial.
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Source: Nanobiotix Official Website
In May 2021, LianTuo Pharmaceuticals acquired the development and commercialization rights of NBTXR3 in Greater China (mainland China, Hong Kong, Macao, and Taiwan), South Korea, Singapore, and Thailand. Nanobiotix will receive a $20 million upfront payment and $220 million in milestone payments.
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