NANOBIOTIX Gets FDA Nod for Phase 2 Study of NBTXR3 in Stage 3 Lung Cancer

NANOBIOTIX, a late-clinical stage biotechnology firm based in Paris and Cambridge, Massachusetts, has announced a significant milestone in its quest to revolutionize cancer treatment. On May 14, 2024, the U.S. Food and Drug Administration (US FDA) issued a Study May Proceed Letter for a randomized Phase 2 study evaluating NBTXR3 for stage 3, unresectable non-small cell lung cancer (NSCLC). This initiative is supported by Johnson & Johnson Enterprise Innovation Inc., a subsidiary of Johnson & Johnson, who submitted the Investigational New Drug (IND) application.

NBTXR3 represents a novel approach in oncology. It comprises functionalized hafnium oxide nanoparticles, administered via a one-time intratumoral injection, and activated by radiotherapy. The product achieved proof-of-concept in soft tissue sarcomas, leading to a European CE mark in 2019. Its physical mechanism of action is designed to trigger significant tumor cell death, subsequently inducing an adaptive immune response and long-term anti-cancer memory. This unique mechanism suggests that NBTXR3 could be effective across various solid tumors treatable with radiotherapy, especially in combination with immune checkpoint inhibitors.

The ongoing development of radiotherapy-activated NBTXR3 spans multiple solid tumor indications, both as a monotherapy and in combination with anti-PD-1 immune checkpoint inhibitors. This includes NANORAY-312, a global, randomized Phase 3 study targeting locally advanced head and neck squamous cell cancers (HNSCC). In February 2020, the US FDA granted Fast Track designation for NBTXR3 activated by radiation therapy, with or without cetuximab, for patients with locally advanced HNSCC who are ineligible for platinum-based chemotherapy.

Dr. Louis Kayitalire, Chief Medical Officer at Nanobiotix, expressed optimism about the new Phase 2 study. He mentioned that the FDA's acceptance of the protocol could broaden the NBTXR3 development pipeline, potentially leading to significant clinical outcomes. He also affirmed the company's commitment to preparing for the study's launch.

Nanobiotix has adopted a collaboration strategy to accelerate the development of NBTXR3 alongside its priority projects. In 2019, the company entered a comprehensive clinical research partnership with The University of Texas MD Anderson Cancer Center, sponsoring several Phase 1 and Phase 2 trials across various tumor types and therapeutic combinations. In 2023, Nanobiotix further expanded its reach through a global co-development and commercialization agreement with Janssen Pharmaceutica NV.

Founded in 2003, Nanobiotix is dedicated to pioneering physics-based therapeutic approaches to enhance treatment outcomes for millions of patients. Headquartered in Paris, France, and listed on Euronext Paris and the Nasdaq Global Select Market, Nanobiotix is committed to pushing the boundaries of medical science to expand human health possibilities. The company holds over 25 patent families covering three nanotechnology platforms applicable in oncology, bioavailability and biodistribution, and central nervous system disorders.

As Nanobiotix advances its innovative cancer treatments, the new Phase 2 study of NBTXR3 for NSCLC represents a critical step in delivering novel oncology solutions to patients worldwide.

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