Nanobiotix (NANO) Status Update summary

Mechanism and clinical potential of NBTXR3

• NBTXR3 is a hafnium oxide nanoparticle radio enhancer that amplifies radiotherapy effects and primes the immune system, showing both local and systemic anti-tumor responses in preclinical and clinical studies.

• Demonstrated safety and efficacy in soft tissue sarcoma, with a tumor-agnostic mechanism and combinability with checkpoint inhibitors or chemotherapy.

• Preclinical data show NBTXR3 enhances cell death, activates immune pathways, and can overcome anti-PD-1 resistance, leading to improved survival and reduced metastasis in animal models.

• Early clinical evidence includes a case of complete response at both injected and non-injected tumor sites in an anti-PD-1 resistant patient.

Unmet needs and current treatment landscape in head and neck cancer

• Locoregionally recurrent or metastatic head and neck cancer has poor survival outcomes, especially in HPV-negative and PD-L1 negative patients.

• Standard treatments include surgery, chemoradiation, and immunotherapy, but long-term survival remains low, with only 16%-19% alive at long-term follow-up in recent studies.

• There is a significant need for improved therapies, particularly for patients refractory to both immunotherapy and platinum-based chemotherapy.

Study 1100: Design, safety, and efficacy

• Study 1100 evaluates NBTXR3 plus SBRT and anti-PD-1 therapy in both anti-PD-1 naïve and resistant head and neck cancer patients.

• Treatment involves a one-time intratumoral injection of NBTXR3, followed by SBRT and then anti-PD-1 therapy.

• Safety profile is favorable, with less than 10% of grade 3 or higher adverse events related to NBTXR3, radiotherapy, or anti-PD-1.