NANOBIOTIX announced a first readout of intermediate data on the safety and feasibility in its Phase I/II trial evaluating NBTXR3 in liver cancers, including primary (Hepatocellular, HCC) and liver metastasis from other tumors. Population treated: Patients with either HCC or liver metastases frequently cannot undergo surgery and have very few or no therapeutic options available. Radiation therapy has been shown to improve outcomes of these patients. Clinical trials have shown a direct correlation between higher doses of radiation therapy and increased survival, in both patient populations. The delivery of a high radiation dose is complex and cannot be done in an optimal way in most situations due to radiation therapy associated toxicity. NBTXR3 aims to amplify the energy dose within the tumor to offer better clinical results and to improve the poor prognosis of these populations. Nanobiotix’s Phase I/II trial evaluates the safety and preliminary efficacy of NBTXR3 nanoparticles administrated by intra-tumoral (IT) or intra-arterial (IA) injection and activated by high precision radiation therapy, delivered as high dose fractions (Stereotactic Body Radiation Therapy (SBRT)) for the treatment of liver cancers. The product has demonstrated a very good safety profile, with no adverse event (serious or not) related to NBTXR3 occurred and no dose-limiting toxicity (DLT). Additionally, the NBTXR3 injections have been demonstrated to be feasible with successful injections in all cases, a good dispersion of the product and the confirmation of its permanence within the tumor structure, from the first day until the last day of radiotherapy treatment, with no negative effect related to the treatment. Importantly, NBTXR3 nanoparticles did not have any impact on the reliability of image-guided radiation therapy (IGRT). Best Overall Response data to date, presented in the table below are based on local assessment on target lesions by mRECIST via MRI. Out of 10 patients treated, 7 are evaluable. Out of these 7 patients, 3 achieved a complete response and 3 a partial response as best overall response. These data are only first preliminary response data which will be completed with additional data. The physical mode of action of NBTXR3 may represent a breakthrough approach for the local treatment of liver cancers, as it does not engage liver and renal functions, i.e. nanoparticles are neither metabolized by the liver nor excreted by the kidney, which is key and highly valuable. The trial is planned to evaluate patients at 10, 15, 22 and 33% NBTXR3 dose level. The two first levels (10 and 15%) have been completed, and the trial is recruiting patients to be treated at 22%. NBTXR3 is also being evaluated in: soft tissue sarcoma (STS), head and neck cancers and prostate cancer. Additionally, head and neck cancer and rectal cancer trials led by Nanobiotix’s Taiwanese partner, PharmaEngine, are underway in the Asia Pacific region.