Key points from article :
Laurent Levy, co-founder, CEO, and chairman of the executive board of Nanobiotix updates on new nanoparticle therapy.
NBTXR3, a potential first-in-class radio enhancer that are delivered via one-time, intratumoral injection and activated by radiotherapy.
Biologically inert outside of the presence of radiation and delivers up to 9 times the dose within the tumor cells where it is present.
Shown a potential to "prime" the immune system by activating several adaptive and innate immune pathways.
The local effect of NBTXR3 has been confirmed in a randomized European phase III trial.
NANORAY-312 aims to enroll 500 patients across sites in the United States, Europe, and Asia.
The primary endpoint of the pivotal study is Progression-free Survival (PFS) and key secondary endpoints include Overall Survival (OS), response rates, and quality of life.
A futility analysis is expected 18 months after the first patient is randomized and an interim analysis is expected at 30 months.
Preliminary data presented at the 2021 Annual Meeting of the American Society for Radiation Oncology (ASTRO 21), supports NBTXR3 administration.
Ongoing median overall survival (mOS) of 17.9 months in all treated populations (n=56) and 23.0 months in evaluable patients (n=44).
Preclinical and clinical development collaboration with MD Anderson, and a development collaboration in Asia with LianBio.
Prioritizing the development of NBTXR3 for elderly and frail patients with locally advanced head and neck cancer who are ineligible for platinum-based chemotherapy.
Already achieved clinical proof of concept for NBTXR3 [] that led to the product's first European market approval (CE mark), under the brand name Hensify®.
