Nanobiotix enters final contract negotiations with major pharma company
James Spargo | May 5, 2023 | News story | Medical Communications |Â Â FDA, Oncology, nanobiotix, oncologyÂ
French late-stage clinical biotechnology company Nanobiotix has announced that it has entered into final contract negotiations with a major pharmaceutical company, after agreement to a non-binding term sheet for development and commercialisation of its lead nanotherapeutic candidate.
NBTXR3 is a novel oncology product consisting of functionalised hafnium oxide nanoparticles which is administered through a one-time intratumoural injection then activated by radiotherapy. It is designed to induce significant tumour cell death which will trigger an adaptive immune response and long-term anti-cancer memory in the body.
In February 2020, the US Food and Drug Administration (FDA) granted NBTXR3 Fast Track designation for the investigation of NBTXR3 activated by radiotherapy, with or without cetuximab, to treat locally advanced head and neck squamous cell carcinoma (HNSCC) patients who are not eligible for platinum-based chemotherapy. This population is also the target for Nanobiotix’s phase 3 global study, which was launched in 2021.
Nanobiotix has also began an immune-oncology development programme. This will involve a phase 1 clinical trial into the efficacy and safety of NBTXR3 as activated by radiotherapy in combination with anti-PD-1 checkpoint inhibitors for patients with locoregional recurrent or recurrent/metastatic HNSCC, or lung or live metastases from any primary cancer eligible for anti-PD-1 therapy.
Due to Nanobiotix’s focus areas and the potential scalability of NBTXR3, Nanobiotix has entered into strategic collaborations with world-class partners, in order to expand the development of NBTXR3.
Until a final contract is signed, the arrangement is subject to negotiation and the execution of a definitive agreement.
James Spargo
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