Nanobiotix, a biotechnology company focusing on nanoparticle-based treatments, has announced new findings from Study 1100, a Phase 1 clinical trial in the United States. This study examines the effects of NBTXR3 followed by anti-PD-1 therapy on patients with recurrent or metastatic head and neck cancer. The data will be presented at the 2024 Annual Meeting of the American Society for Clinical Oncology (ASCO).
Colette Shen, MD, PhD, the Coordinating Investigator for Study 1100, will present the data during a poster session on June 2, 2024, at ASCO. The session will highlight the outcomes from the completed dose escalation phase and the ongoing expansion phase of the study. A total of 68 patients were enrolled, and the early results are promising for those who had not previously been treated with anti-PD-1 (n=33) as well as those who had shown resistance to anti-PD-1 therapy (n=35).
The abstract, identified as #6035, details the efficacy signals seen in patients treated with NBTXR3 combined with stereotactic body radiation therapy (SBRT) and the immune checkpoint inhibitors nivolumab and pembrolizumab. This combination therapy aims to enhance the anti-cancer effects by leveraging both radiation and immune response mechanisms.
Following the presentation, Nanobiotix will hold an investor event to discuss the results in more detail. This event will be hosted by the company's CEO and chairman, Laurent Levy, and will take place on June 2, 2024, at 12:00 PM EDT. Investors are encouraged to join via an audio-only dial-in link or a webcast, with details available on Nanobiotix’s website.
NBTXR3, the focus of this study, is a novel oncology product composed of hafnium oxide nanoparticles. It is introduced directly into tumors and activated by radiotherapy. This method aims to induce significant tumor cell death and trigger an adaptive immune response, potentially providing long-term immunity against cancer. The product received a European CE mark in 2019 for treating soft tissue sarcomas and is currently being tested in various solid tumors.
The ongoing NANORAY-312 study is a global Phase 3 trial evaluating radiotherapy-activated NBTXR3 in locally advanced head and neck squamous cell carcinoma. The U.S. Food and Drug Administration granted Fast Track designation for NBTXR3 in 2020 for patients who are not eligible for platinum-based chemotherapy, which is the same group being studied in the Phase 3 trial.
In pursuit of expanding the development of NBTXR3, Nanobiotix has collaborated with The University of Texas MD Anderson Cancer Center since 2019. This partnership supports multiple Phase 1 and Phase 2 studies across various tumor types and treatment combinations. Additionally, in 2023, Nanobiotix entered a license agreement with Janssen Pharmaceutica NV for the global co-development and commercialization of NBTXR3.
Founded in 2003, Nanobiotix is based in Paris, France, and has been listed on Euronext Paris since 2012 and on the Nasdaq Global Select Market since December 2020. The company operates subsidiaries in Cambridge, Massachusetts, and other locations worldwide. Nanobiotix holds more than 25 patent families related to its nanotechnology platforms, which have applications in oncology, bioavailability, biodistribution, and central nervous system disorders.
Nanobiotix continues to push the boundaries of cancer treatment, aiming to significantly improve outcomes for patients through innovative, physics-based approaches.
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