First Clinical Trial Testing NBTXR3 Plus Immune Checkpoint Inhibitors to Recruit Patients in the US

First Clinical Trial Testing NBTXR3 Plus Immune Checkpoint Inhibitors to Recruit Patients in the US

The late-clinical-stage company Nanobiotix, which works toward developing new cancer treatment approaches, announced that it will soon launch its first clinical trial with NBTXR3 in combination with immune checkpoint inhibitors in the U.S.

The clinical study will recruit patients with recurrent head and neck cancer and metastatic lung cancer. It aims to transform patients who fail to respond to checkpoint inhibitors into responders, while also improving patient outcomes.

The trial will determine the potential of NBTXR3 to achieve what is known as the abscopal effect, or its ability to trigger systemic antitumor effects. The study, to be conducted in the U.S., will also allow scientists to further evaluate NBTXR3 and expand its use to other recurrent or metastatic cancers.

NBTXR3 is a nano-sized compound composed of hafnium oxide nanoparticles. The drug is directly administered into the tumor site and was first designed to enhance radiotherapy’s effectiveness.

In a Phase 3 trial with patients with soft tissue sarcoma (NCT02379845), only those treated with NBTXR3 plus radiotherapy had a significant increase in the number of T-cells inside the tumor, while this increase was not observed in patients treated with radiotherapy alone. Later, Nanobiotix announced NBTXR3’s ability to make a tumor responsive to immunotherapy.

Immunotherapies act by enhancing the body’s natural immune system responses against tumor cells, and in recent decades, they have produced promising results. However, several tumor types respond poorly to therapies targeting the immune system. These are often referred to as “cold” tumors because a lack of response is associated with few numbers or immune cells within tumors.

On the contrary, those that respond to these therapies are called “hot” tumors and are effectively targeted by cells of the immune system.

Previous studies reported that only a small fraction of patients with non-small-cell lung cancer (NSCLC) and head and neck squamous cell carcinoma respond to immunotherapy treatments.

NBTXR3 is capable of effectively turning a “cold” tumor into a “hot” tumor, thus researchers will test if it can induce the same phenotype in naturally non-responding patients treated with immune checkpoint inhibitors, which are designed to unleash an immune system attack on cancer cells.

“The immunomodulatory effects of NBTXR3 have the potential to transform non-responders into responders,” Elsa Borghi, Nanobiotix’s chief medical officer, said in a press release. “This approach could be practice-changing, as it addresses unmet medical needs through directed tumor in situ vaccination.”