FDA Approved Nanobiotix for First Immuno-Oncology Trial
Nanobiotix, a nanomedicine announced the approval of U.S. Food and Drug Administration (FDA) on December 26, 2017, for Investigational New Drug (IND) Application.
NBTXR3 is a first in class nanoparticle designed for direct injection into cancerous tumors, which is activated by stereotactic ablative radiotherapy (SABR) and administered into the body with combination of anti-PD1 antibody (nivolumab or pembrolizumab). “Advancing our demonstration of NBTXR3’s potential to turn checkpoint inhibitor non-responders into responders could be game-changing and the approach could address the unmet medical needs of a significant number of patients. Based on existing pre-clinical and clinical data, NBTXR3 could become a backbone in immuno-oncology,” said Laurent Levy, CEO of Nanobiotix.
The study is expected to be conducted in two consecutive phases, which includes dose escalation, followed by a dose expansion phase. 36 to 72 patients are expected to be enrolled in Phase I and 40 patients in Phase II for the study. NBTXR3-1100 includes three cohorts of patients with recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC) or with metastatic non-small cell lung cancer (NSCLC). While NBTXR3 and Radiotherapy doses will be escalated and the anti-PD1 antibody dose will remain constant. The dose expansion phase will be selected based on the preliminary risk-benefit ratio assessment observed in Phase I portion of the trial.
Primary and secondary endpoints are expected to evaluate efficacy and safety, while exploratory endpoints characterize the treatment-induced genomic alterations. According to the Immunotherapy Drugs Market report published by Coherent Market Insights, Immuno-oncology therapy enhance, suppress or inducing an immune response. They are useful for treatment for some types of cancer. Immuno-oncology agents can boost immune system response by priming it for active attack against tumor cells. While the response to checkpoint inhibitors is infiltrated by T-cells and characterized by an inflammatory profile, which has long-lasting clinical benefits in cancer patients.
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