Nanobiotix Receives FDA Protocol Acceptance for Lung Cancer Study
Biotechnology company Nanobiotix announced its NBTXR3 investigational therapy has received U.S. Food and Drug Administration (FDA) protocol acceptance for a randomized Phase 2 study. The study will evaluate NBTXR3 in patients with stage three, unresectable non-small cell lung cancer.
Biotechnology firm Nanobiotix has secured U.S. Food and Drug Administration (FDA) protocol acceptance for a randomized Phase 2 study of its NBTXR3 investigational therapy. The trial will assess NBTXR3 as a treatment for patients diagnosed with stage three, unresectable non-small cell lung cancer (NSCLC).
The acceptance of the study protocol represents a significant advancement in the NBTXR3 development pipeline, potentially extending its application to a new therapeutic area. NBTXR3 is comprised of functionalized hafnium oxide nanoparticles administered via a single intratumoral injection and activated by radiotherapy. Nanobiotix posits that the therapy's physical mechanism of action could be scalable across various solid tumors, particularly when used in conjunction with other treatments like immune checkpoint inhibitors.
The Phase 2 study is sponsored by Johnson & Johnson Enterprise Innovation Inc., a Johnson & Johnson company, which has also submitted an Investigational New Drug (IND) application to support the trial. Nanobiotix has previously demonstrated proof-of-concept for NBTXR3 in other cancer indications, including obtaining a European CE mark for the treatment of soft tissue sarcomas in 2019.
Nanobiotix is pursuing multiple development pathways for NBTXR3 and has established strategic collaborations with entities such as The University of Texas MD Anderson Cancer Center and Janssen Pharmaceutica NV to advance the product candidate's research and commercialization efforts.