NANOBIOTIX announced its global development strategy for 2020 and beyond, following proof-of-concept (POC) and European market approval for NBTXR3 in locally advanced soft tissue sarcoma of the extremities and trunk wall (Brand Name: Hensify) in 2019. The Company will continue to prioritize its registration pathway in the US and EU for the treatment of head and neck cancers, while also working to advance the Nanobiotix immuno-oncology (I/O) program and evaluate NBTXR3 in other indications such as lung, pancreatic, esophageal, hepatocellular carcinoma (HCC), prostrate, and rectal cancers. To execute this plan, Nanobiotix will focus on H&N cancers while its collaborators (i.e. The University of Texas MD Anderson Cancer Center (MD Anderson) in the US and PharmaEngine in Asia) are working on other indications. There are approximately 700,000 new head and neck cancer patients worldwide each year—300,000 of these patients reside in the US and the European Union (EU). Of these patients at diagnosis, 90% suffer from local disease and the remaining 10% have metastatic disease. 70-80% of all Head and Neck patients will receive radiation therapy, but significant unmet medical needs remain regarding either local control, systemic control, toxicity, or some combination of the three. This is especially challenging for patients ineligible for platinum-based chemotherapy (cisplatin). More than half of head and neck cancers include large primary tumors which may invade underlying structures and/or spread to regional nodes. Treatment of these locally advanced forms of the disease ordinarily requires aggressive, concerted measures. Due to potential comorbidities and toxicities associated with treatment, elderly and frail patients suffer from limited therapeutic options. Study 312 aims to target the unmet needs of this population. Patients in the control arm will receive radiation therapy with or without cetuximab (investigator’s choice), and patients in the treatment arm will receive NBTXR3 activated by radiation therapy with or without cetuximab (investigator’s choice). The trial will recruit around 500 patients, the initial readout will be based on event-driven progression-free survival (PFS), and the final readout will be based on PFS and overall survival (OS). The study will be powered to demonstrate the OS superiority of NBTXR3 activated by radiation therapy. In addition, quality of life (QoL) will be measured as a key secondary outcome. The Company’s next step is to submit the final trial design to FDA and other global regulatory bodies within the month. A futility analysis is expected 18 months after the first patient is randomized, the interim analysis for PFS superiority is expected at 24-30 months, and final analysis will report on PFS and OS. In the event of favorable data from the initial readout, Nanobiotix plans to apply for conditional registration in the US.