Nanobiotix Reports Disease Control and Tumor Response in RT-Activated NBTXR3 With anti-PD-1 for HNSCC

PARIS and CAMBRIDGE, Mass., June 2, 2024 -- Nanobiotix, a biotechnology company specializing in nanoparticle-based therapies for cancer and other severe diseases, announced new findings from their ongoing Study 1100 at the 2024 Annual Meeting of the American Society for Clinical Oncology (ASCO). The study assesses the safety, feasibility, and early efficacy signals of radiotherapy-activated NBTXR3 followed by anti-PD-1 immune checkpoint inhibitors in patients with recurrent or metastatic head and neck squamous cell carcinoma (R/M-HNSCC).

Study Overview

Study 1100 is a US-based Phase 1 study involving dose escalation and dose expansion phases. It evaluates the combination of NBTXR3 activated by radiotherapy (RT) followed by anti-PD-1 therapy in heavily pre-treated patients with advanced solid and metastatic tumors. This combination aims to "prime" the immune system to enhance the response to anti-PD-1 inhibitors, addressing the urgent need to improve outcomes for patients who are either resistant or new to anti-PD-1 treatment.

Patient Population and Results

Data were presented for 68 patients in total. The study included two primary groups: anti-PD-1 naïve patients (those who had never received anti-PD-1 therapy) and anti-PD-1 resistant patients (those who had previously received anti-PD-1 therapy without sufficient response).

- Anti-PD-1 Naïve Patients (n=25 evaluable for tumor response):
- Overall Response Rate (ORR): 48% as per RECIST 1.1 criteria.
- Disease Control Rate (DCR): 76%.
- Median Progression-Free Survival (mPFS): 7.3 months.
- Median Overall Survival (mOS): 26.2 months.

- Anti-PD-1 Resistant Patients (n=25 evaluable for tumor response):
- ORR: 28%.
- DCR: 68%.
- mPFS: 4.2 months.
- mOS: 7.8 months.

Safety Profile

The combination therapy was generally well tolerated. Serious Grade 3 or higher adverse events related to the treatment were reported in 8.8% of the patients. This suggests that NBTXR3 activated by RT, followed by anti-PD-1 therapy, is feasible for this patient population.

Expert Insights

Coordinating Investigator Dr. Ari Rosenberg emphasized the potential of this new treatment approach: "Priming the immune response with radiotherapy-activated NBTXR3 before administering anti-PD-1 therapy shows promise in improving response rates and overcoming resistance in head and neck cancer." This sentiment was echoed by Nanobiotix's Chief Medical Officer, Dr. Louis Kayitalire, who noted that the treatment's unique mechanism of action could benefit a broader patient population, regardless of prior therapy lines, CPS score, or HPV status.

Future Directions

Nanobiotix plans to further explore these promising early findings in randomized clinical trials. Additionally, data from cohort 3 of the study, which includes patients with advanced cancers other than R/M-HNSCC, are expected in 2025.

About NBTXR3

NBTXR3 is an innovative oncology product composed of functionalized hafnium oxide nanoparticles. Administered via intratumoral injection and activated by radiotherapy, it is designed to induce significant tumor cell death, activate adaptive immune responses, and generate long-term anti-cancer memory. Its physical mechanism of action suggests scalability across various solid tumors treatable with radiotherapy and in combination with other therapies, particularly immune checkpoint inhibitors.

Company Overview

Founded in 2003, Nanobiotix is headquartered in Paris, France, with additional locations including Cambridge, Massachusetts. The company focuses on disruptive, physics-based therapeutic approaches to improve treatment outcomes for cancer patients. Nanobiotix is listed on Euronext Paris and the Nasdaq Global Select Market.

In conclusion, the new data from Nanobiotix's Study 1100 present encouraging evidence that radiotherapy-activated NBTXR3 followed by anti-PD-1 therapy could significantly improve clinical outcomes for patients with recurrent or metastatic head and neck cancer. Further studies are underway to confirm these findings and expand treatment options for this challenging patient population.

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