On March 27, 2025 NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-stage clinical biotechnology company pioneering disruptive, nanotherapeutic approaches to revolutionize treatment outcomes for millions of patients, reported the first data from the completed dose escalation part of a Phase 1 study sponsored by The University of Texas MD Anderson Cancer Center ("MD Anderson") evaluating radiotherapy-activated NBTXR3 (JNJ-1900)1 as a second or later line (2L+) therapy for patients with locally advanced non-small cell lung cancer ("NSCLC") amenable to re-irradiation (Press release, Nanobiotix, MAR 27, 2025, View Source [SID1234651532]). These data will be presented at the 2025 European Lung Cancer Conference by study principal investigator Dr. Saumil Gandhi.

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ABSTRACT #207P: Phase 1 Study of Reirradiation ("ReRT") with NBTXR3 (JNJ-1900) for Inoperable Locoregional Recurrent Non-Small Cell Lung Cancer ("NSCLC")
Saumil J. Gandhi, MD, PhD, Enoch Chang, MD, Aileen Chen, MD, Stephen G. Chun, MD, Steven H. Lin, MD, PhD, Rachel C. Maguire, BS, Matthew S. Ning, MD, MPH, Julianna K. Bronk, MD, PhD, David Qian, MD, Joe Y. Chang, MD, PhD, James W. Welsh, MD, Zhongxing Liao, MD, Rahul A. Sheth, MD, Roberto F. Casal, MD

Locoregional recurrence occurs in 30-40% of patients with locally advanced NSCLC after treatment with definitive chemoradiation. Historically, patients who are amenable to re-irradiation are often limited to palliative doses due to associated toxicities. As such, strategies to enhance the therapeutic ratio of radiotherapy are needed to improve treatment outcomes.

"Patients with recurrence after prior radiation therapy for locally advanced lung cancer face limited therapeutic options and significant challenges in achieving durable disease control," said Saumil Gandhi, MD, PhD, Department of Thoracic Radiation Oncology, Division of Radiation Oncology at MD Anderson. "These data underscore the need for continued therapeutic innovation for these patients and highlight the potential of NBTXR3 (JNJ-1900) as a novel approach to improving patient outcomes."

Results from the completed dose escalation part of the study demonstrated a favorable safety profile with no dose-limiting toxicities (DLTs), and no Grade 3 or higher SAEs related to NBTXR3. Injection feasibility was confirmed, and the recommended phase 2 dose (RP2D) was established at 33% of gross tumor volume.

Promising early efficacy signals were observed. Preliminary review of survival data from 12 patients showed 12-month LPFS of 64% (median 18.6 months) and 12-month OS of 83% (median 30.2 months), further supporting the potential clinical benefit of NBTXR3 (JNJ-1900) in this patient population.

"The Nanobiotix team is encouraged by these early findings, which suggest NBTXR3 (JNJ-1900) could offer a new therapeutic option for patients with no alternatives after prior treatments have failed," said Louis Kayitalire, MD, Nanobiotix Chief Medical Officer. "Notably, these results were observed in patients who resisted prior curative radiation doses and that were treated with JNJ-1900 (NBTXR3) activated by a lower radiation dose. As we advance the study’s expansion phase, we look forward to further evaluating NBTXR3 (JNJ-1900)’s potential to improve patient outcomes."

The expansion phase of the study is ongoing, with 5/12 patients injected to date.

About JNJ-1900 (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. Its proof-of-concept was achieved in soft tissue sarcomas for which the product received a European CE mark in 2019. 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.

Radiotherapy-activated NBTXR3 is being evaluated across multiple solid tumor indications as a single agent or in combination with anti-PD-1 immune checkpoint inhibitors, including in NANORAY-312—a global, randomized Phase 3 study in locally advanced head and neck squamous cell cancers. 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.

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 2 studies evaluating NBTXR3 across tumor types and therapeutic combinations. In 2023, Nanobiotix announced a license agreement for the global co-development and commercialization of NBTXR3 with Janssen Pharmaceutica NV, a Johnson & Johnson company.