Pharma Focus Europe

NANOBIOTIX Commences Novel Phase 1/2 Study to Assess Radiotherapy-activated NBTXR3 Alongside Anti-PD-1 Therapy in Advanced Cancer Patients

Thursday, July 20, 2023

Nanobiotix, a late-stage biotechnology company focused on advancing cancer treatments through physics-based approaches, has announced the initiation of a Phase 1/2 study to evaluate their product NBTXR3 in combination with anti-PD-1/L-1 immune checkpoint inhibitors for treating patients with advanced solid tumor malignancies that have spread to the lungs or liver. The company has already injected the first patient in this study.

NBTXR3 is a novel oncology product made up of functionalized hafnium oxide nanoparticles, delivered through a one-time intratumoral injection and activated by radiotherapy. The unique mechanism of action aims to induce significant tumor cell death and trigger an adaptive immune response, leading to long-term anti-cancer effects.

The strategic collaboration between Nanobiotix and The University of Texas MD Anderson Cancer Center includes five actively recruiting trials. These trials involve NBTXR3 in combination with anti-PD-1, radiotherapy, and chemotherapy for different types of cancer, including head and neck cancer, non-small cell lung cancer, pancreatic cancer, and esophageal cancer.

Nanobiotix is optimistic about the potential benefits of NBTXR3 and believes that it can be scalable across various solid tumors treatable with radiotherapy, particularly when combined with immune checkpoint inhibitors.

The company has already obtained positive safety data and early signs of efficacy from their Phase 1 dose escalation and dose expansion study for locally advanced head and neck squamous cell carcinoma (HNSCC). They have launched a Phase 3 global registrational study for the same indication, and the United States Food and Drug Administration has granted Fast Track designation for this investigation.

Furthermore, Nanobiotix has initiated an Immuno-Oncology development program to explore NBTXR3 in combination with anti-PD-1 checkpoint inhibitors for other cancer types.

The collaboration with The University of Texas MD Anderson Cancer Center, as well as agreements with other partners, has allowed Nanobiotix to expand the development of NBTXR3 in various clinical studies, thereby advancing its potential in cancer treatment. The company expects data from these collaborations to be presented in the second half of 2023.

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