On July 19, 2023 NANOBIOTIX (Euronext: NANO — NASDAQ: NBTX – the "Company"), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported that the first patient has been injected in a Phase 1/2 study evaluating NBTXR3 activated by radiation therapy in combination with anti-PD-1/L-1 immune checkpoint inhibitors for the treatment of patients with advanced solid tumor malignancies that have spread to lungs (lung metastases) and/or liver (liver metastases) (Press release, Nanobiotix, JUL 19, 2023, View Source [SID1234633318]). The trial (NCT05039632) is being conducted as part of an ongoing strategic collaboration between Nanobiotix and The University of Texas MD Anderson Cancer Center evaluating radiotherapy-activated NBTXR3 across solid tumor indications and treatment combinations.
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"Fundamental in the effort to bring the potential benefits of NBTXR3 to millions of patients around the world is an expansive development program that pushes the scientific boundaries of oncology," said Leonard A. Farber, MD, Chief Clinical and Medical Affairs Officer at Nanobiotix. "This collaboration expands development of NBTXR3 across solid tumor indications, therapeutic combinations, and treatment modalities in parallel with studies led by Nanobiotix. We are pleased with the momentum we continue to build in our program and look forward to the opportunity to bring NBTXR3 to more patients."
This new study expands the ongoing strategic collaboration to five actively recruiting trials. Beyond the new study, the additional active studies in the collaboration include:
A Phase 2 study of radiotherapy-activated NBTXR3 in combination with anti-PD-1 for patients with recurrent or metastatic head and neck cancer (NCT04862455)
A Phase 1 study of radiotherapy-activated NBTXR3 for patients with inoperable non-small cell lung cancer (NCT04505267)
A Phase 1 study of radiotherapy-activated NBTXR3 for patients with pancreatic cancer (NCT04484909)
A Phase 1 study of NBTXR3 activated by radiotherapy in combination with chemotherapy for patients with esophageal cancer (NCT04615013)
Nanobiotix expects data from the collaboration to be presented in H2 2023.
About NBTXR3
NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.
NBTXR3 is being evaluated in locally advanced head and neck squamous cell carcinoma (HNSCC) as the primary development pathway. The company-sponsored Phase 1 dose escalation and dose expansion study has produced favorable safety data and early signs of efficacy; and a Phase 3 global registrational study was launched in 2021. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the Phase 3 study.
Nanobiotix has also prioritized an Immuno-Oncology development program—beginning with a Company-sponsored phase I clinical study evaluating NBTXR3 activated by radiotherapy in combination with anti-PD-1 checkpoint inhibitors for patients with locoregional recurrent or recurrent/metastatic HNSCC, or lung or liver metastases from any primary cancer eligible for anti-PD-1 therapy.
Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several Phase 1 and phase II studies to evaluate NBTXR3 across tumor types and therapeutic combinations. In 2021, the Company announced an agreement with LianBio to expand development of NBTXR3 into Greater China and other Asian Markets, and in 2023 Nanobiotix announced a license agreement for the global co-development and commercialization of NBTXR3 with Janssen Pharmaceutica NV.