News | Radiation Therapy | October 07, 2021

Poster presentation by Pr. Christophe Le Tourneau featuring first OS and PFS data from phase I expansion study of NBTXR3 as a single agent activated by radiotherapy in tough-to-treat HNSCC population

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.

October 7, 2021 — NANOBIOTIX, a late-stage clinical biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, today announced two oral presentations and three poster presentations at the 2021 Annual Meeting of the American Society for Radiation Oncology (ASTRO). The meeting will be held from October 24-27, 2021.

“Bringing disruptive therapeutic solutions that expand treatment possibilities for patients with cancer starts with making a meaningful impact on survival,” said Laurent Levy, co-founder and chairman of the executive board of Nanobiotix. “Delivering the first look at these exploratory endpoints in our phase I head and neck cancer study will provide useful insight into the potential of our innovation in our priority indication as we prepare to launch our global phase III. While we continue to develop NBTXR3 as a broadly applicable potential therapy across solid tumor types and therapeutic combinations in parallel, we also look forward to presenting updates in immunotherapy and soft tissue sarcoma as well.”

Oral and Poster Presentation Details:

Local Control with NBTXR3 as a Single-Agent for Patients with Head and Neck Cancer

  • Poster presentation #2805: Phase I Study of Novel Radioenhancer NBTXR3 Activated by Radiotherapy in Cisplatin-Ineligible Locally Advanced HNSCC Patients by Christophe Le Tourneau, MD, PhD, on October 26 at 1:15 PM CDT / 8:15 PM CET

NBTXR3 Tumor-Agnostic, Therapeutic Combination-Agnostic Development Potential

  • Oral presentation #132: Overcoming Resistance to Anti-PD-1 With Tumor Agnostic NBTXR3: From Bench to Bedside by Tanguy Y. Seiwert, MD, on October 26 at 4:20 PM CDT / 11:20 PM CET

Priming Immune Response with NBTXR3 plus Anti-PD-1 in Advanced Cancers

  • Poster presentation #2739: NBTXR3 Activated by Radiotherapy in Combination with Nivolumab or Pembrolizumab in Patients with Advanced Cancers: A Phase I Trial by Colette Shen, MD, PhD, on October 25 at 4:00 PM CDT / 11:00 PM CET

Local Control with NBTXR3 as a Single-Agent for Patients with Soft Tissue Sarcoma

  • Oral presentation #77: Study of Novel Radioenhancer NBTXR3 Plus Radiotherapy in Patients with Locally Advanced Soft Tissue Sarcoma: Results of the Long-Term Evaluation in the Phase II/III Act.In.Sarc Trial by Sylvie Bonvalot, MD, PhD, on October 26 at 5:15 PM CDT / 12:15 AM CET

Preclinical Data on NBTXR3 plus Anti-PD-1 in Lung Cancer Model

  • Poster presentation #2865: NBTXR3 Nanoparticle with ImmunoRadiation Might Reshape Metastatic Tumor-Infiltrating T Cell Repertoire in Murine Lung Cancer Model by Chike O. Abana, MD, PhD, on October 26 3:30 PM CDT / 10:30 PM CET

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 I dose escalation and dose expansion study has produced favorable safety data and early signs of efficacy; and a phase III global registrational study is planned to launch 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 planned phase III 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 and 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 strategic collaboration strategy with world class partners 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 I and phase II studies to evaluate NBTXR3 across tumor types and therapeutic combinations.

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