Nanobiotix will soon initiate a Phase 1/2 trial of NBTXR3 in combination with an anti-PD-1 antibody — Bristol-Myers Squibb’s Opdivo (nivolumab) or Merck’s Keytruda (pembrolizumab) — in patients with advanced head and neck squamous cell carcinoma (HNSCC) or metastatic non-small cell lung cancer (NSCLC).
This comes in the wake of the U.S. Food and Drug Administration’s approval of Nanobiotix’s investigational new drug (IND) application for NBTXR3.
“The FDA’s approval of Nanobiotix’s IND application for this trial is a major milestone for our Company,” Laurent Levy, CEO of Nanobiotix, said in a press release. “We’re ready and excited to launch our first immuno-oncology clinical trial in the U.S. combining NBTXR3 with a checkpoint inhibitor.”
NBTXR3 is a nano-sized compound composed of hafnium oxide nanoparticles. The drug is directly administered into the tumor site and was initially designed to enhance the effectiveness of radiotherapy.
But additional research revealed that NBTXR3 also has the ability to make a tumor responsive to immunotherapy.
Nanobiotix designed the open-label clinical trial to see if NBTXR3 can be used to improve responses to immune checkpoint inhibitors. The study will include a population that usually does not respond well to immunotherapies, allowing researchers to assess whether the drug can overcome resistance to these treatments.
The trial has two parts. In the first phase, researchers will test different doses of NBTXR3 and radiation, along with fixed doses of either Opdivo or Keytruda, to determine the safest and more effective combination for future studies.
For the second phase, the best immune checkpoint inhibitor will be selected to be used with NBTXR3, and researchers will continue to test its efficacy.
The trial will also evaluate treatment-induced genetic modifications that are associated with long-lasting clinical benefits.
“Based on existing pre-clinical and clinical data, NBTXR3 could become a backbone in immuno-oncology,” Levy said. “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.”
The NBTXR3-1100 trial will be led by Tanguy Seiwert, MD, of the University of Chicago Medical Center, and Jared Weiss, MD, of the University of North Carolina at Chapel Hill.
The company plans to start dosing patients during the second quarter of 2018, and interim data is expected by the summer of 2019.