The designation has been granted for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, to treat patients with locally advanced head and neck squamous cell cancer (HNSCC) who are not eligible for platinum-based chemotherapy.
The NBTXR3 is a first-in-class product designed to damage tumours via physical cell death when activated by radiotherapy.
Nanobiotix’s first-in-class product needs one single administration before the first radiotherapy treatment session.
According to the company, the NBTXR3’s physical mode of action allows applying across solid tumours such as lung, prostate, liver, glioblastoma, and breast cancers.
The company is evaluating NBTXR3 in locally HNSCC of the oral cavity or oropharynx in elderly and frail patients unable to secure chemotherapy or cetuximab with limited therapeutic options.
Nanobiotix has reported significant results in the phase I trial that related to local control. Nanobiotix began the regulatory process for the clinical authorisation of a phase II/III trial in locally advanced head and neck cancers.
The company is also running an immuno-oncology development programme, as well as secured FDA approval to conduct a clinical trial of NBTXR3 activated by radiotherapy in combination with anti-PD-1 antibodies in locoregional recurrent (LRR) or recurrent and metastatic (R/M) HNSCC amenable to re-irradiation of the HN and lung or liver metastases (mets) from any primary cancer eligible for anti-PD-1.
The firm’s other ongoing NBTXR3 studies are treating patients with hepatocellular carcinoma (HCC) or liver metastases, locally advanced or unresectable rectal cancer in combination with chemotherapy, head and neck cancer in combination with concurrent chemotherapy, and prostate adenocarcinoma.
In addition, the firm announced a clinical research collaboration with The University of Texas MD Anderson Cancer Center to assess NBTXR3 across head and neck, pancreatic, thoracic, lung, gastrointestinal and genitourinary cancers.
In 2012, PharmaEngine entered into a licence and collaboration agreement to develop and commercialise Nanobiotix’s NBTXR3 radioenhancer in Australia, China, India, Japan, Korea, Taiwan and other countries in the Asia-Pacific region.