NANOBIOTIX
Late clinical-stage nanomedicine company Nanobiotix has been authorised to begin a new clinical trial in liver cancers for its lead NanoXray product, NBTXR3.
The French National Agency for Medicines and Health Products (ANSM) has given Nanobiotix the green light to start a Phase I/II trial for NBTXR3 in two new cancer populations — hepatocellular cancer (HCC) and liver metastases. The multinational, non-randomised, open Phase I/II study will evaluate the use of NBTXR3, delivered as high dose fractions via stereotatic body radiation therapy (SBRT), regarded as the safest radiotherapy currently available for the treatment of malignant liver tumours.
Nanobiotix's liver cancer trial is supported by a broad NBTXR3 preclinical programme specific to liver cancers, showing that the use of the product is feasible and well tolerated in animals. The new clinical trial is part of the nanomedicine NICE consortium financed by Bpifrance.
Liver cancers are challenging diseases to address. Most patients, either with HCC or liver metastases, cannot benefit from surgery and have few or no therapeutic options available to them.
Clinical trials showing a direct correlation between higher doses of radiation therapy and better outcomes, including survival. However, high doses of radiation in the liver (vital organ) are not usually feasible. SBRT has been shown to be efficient only in specific subsets of population with small tumours. Complete response is a rare event and local control is often compromised in big tumours, metastases and HCC, with portal vein tumour thrombosis and short progression free survival and overall survival.
NBTXR3 is activated by radiotherapy and works by the deposit of increased energy doses (radio-enhancement) within the tumour. NBTXR3 may significantly increase the intratumour energy dose with higher destruction and improve the patient outcome in terms of higher tumour shrinkage, local control and overall survival.
Elsa Borghi, CMO of Nanobiotix said: "This clinical trial has been designed to test the safety and preliminary efficacy in patients representing three indications (two in HCC and one in liver metastases). Structure and number of patients per group have been chosen based on statistical hypothesis in comparison with literature for an efficient early de-risking. This approach could allow rapid efficacy results to be gathered, opening a faster pathway to market."