NANOBIOTIX Provides Updates on Global Clinical Development Plan for First-in-class Radioenhancer NBTXR3 at ASTRO 2020
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NANOBIOTIX (Euronext : NANO – ISIN : FR0011341205 – the ‘‘Company’’) today announced updates to the Company’s global development plan for first-in-class radioenhancer NBTXR3 at the 2020 American Society for Radiation Oncology (ASTRO) Annual Meeting.
While the COVID-19 crisis and subsequent measures to curtail the spread of the virus have created challenges in clinical trial recruitment, a sharpened focus on the Company’s priority pathways in head and neck cancer and immunotherapy has led to the continued achievement of necessary milestones for the development of lead product candidate NBTXR3. Moreover, diligent efforts in collaboration with The University of Texas MD Anderson Cancer Center (MD Anderson) in the United States (US) has helped to advance expansion of the development plan across new indications.
Priority Development in Head and Neck Cancer and Immunotherapy
Pathway to Global Registration in Head and Neck Cancer On Track
Nanobiotix has presented an update on the expansion part of the Company’s phase I study evaluating NBTXR3 activated by radiation therapy for patients with head and neck cancer (Study 102) at ASTRO 2020. In 31 evaluable patients, positive results confirmed the target lesion objective response rate presented earlier this year at 83.9% and showed an increase in target lesion complete response rate at 67.7%. The target lesion complete response rate is an increase over previously reported data (60%) with additional follow up (7.8-month median follow up vs. 5 months). Additionally, data showed an overall objective response rate of 83.9% and an overall complete response rate of 48.4%, which were also increases over previously reported data (83% and 43% respectively).
The trial has recruited 44 patients in total (31 evaluable to date), and will remain ongoing until reaching 44 evaluable patients. The next update on the study is expected in the second quarter of 2021.
Preparation for the Company’s pivotal phase III trial evaluating NBTXR3 activated by radiation therapy for patients with head and neck cancer (NANORAY-312) is ongoing as planned. The trial is expected to commence after the financing to fund the trial is secured.
As previously announced, NBTXR3 activated by radiation therapy for the population in NANORAY-312 received Fast Track designation from the US Food and Drug Administration (FDA) in February 2020. Fast Track is a process designed to facilitate the development and accelerate the review of drugs for serious conditions and that have the potential to address unmet medical needs. The purpose is to expedite the availability of new treatment options for patients.