NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, today announces 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.
Nanobiotix Chief Medical Officer Elsa Borghi, said: “This study successfully demonstrated the safety and the feasibility of the treatment for two different and important indications in liver oncology. These results open a promising pathway for NBTXR3 in patients highly vulnerable.“
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.
Results presented at ASCO GI annual meeting (Abstract #202303)
A phase I/II trial of NBTXR3 nanoparticles activated by SBRT in the treatment of liver cancers. (Poster board ID TPS 551, Authors: Enrique Chajon, Marc Pracht, Thierry De Baere, France Nguyen, Jean-Pierre Bronowicki, Veronique Vendrely, Anne-Sophie Baumann, Valérie Croisé-Laurent, Eric Deutsch; Centre Hospitalier Universitaire de Rennes, Rennes, France; Centre Eugene MARQUIS, Rennes, France; Department of Imaging and Therapeutic Imaging, Gustave Roussy and Paris-Sud University, Villejuif, France; Institut Gustave Roussy, Villejuif, France; INSERM 954, CHU de Nancy, Université de Lorraine, Nancy, France; CHU Bordeaux, Bordeaux, France; Institut de Cancérologie de Lorraine, Nancy, France).
Enrollment was completed for dose levels 10% (6 pts) and 15% (4 pts). The recruitment at 22% which is the third dose level, is ongoing.
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).
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.