Nanobiotix, a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, announced that it is launching a research collaboration with Weill Cornell Medicine to begin non clinical studies of NBTXR3's mechanism of action. NBTXR3 is a first-in-class product designed to destroy, when activated by radiotherapy, tumors and metastasis through physical cell death and to induce immunogenic cell death leading to specific activation of the immune system.

The research collaboration between Weill Cornell Medicine, based in New York City, and Nanobiotix will be conducted over the course of one year, with the goal of continuing the exploration of the role of NBTXR3 in Immuno-Oncology.

The main objective of this collaboration is to study the impact of NBTXR3 activated by radiotherapy on the cGAS-STING pathway using different in vitro and in vivo murine models (mammary). Along with immunogenic cell death, the cGAS-STING pathway has emerged as the key component of the anti-tumor immune response. Data generated from this collaboration could support current evidence indicating that NBTXR3 activated by radiotherapy can increase the anti-tumor immune response, compared with radiotherapy alone, and transform an irradiated tumor into an efficient in situ vaccine.

Dr. Sandra Demaria, M.D., Professor of Radiation Oncology and Chief of the Division of Experimental Radiotherapy in the Department of Radiation Oncology at Weill Cornell Medicine, and Principal Investigator for the study, said: "We have learned that radiotherapy has the potential to convert a tumor into an in-situ vaccine, and enhance systemic tumor responses to immunotherapy. But there is room for improvement: NBTXR3 nanoparticles enhance the pro-immunogenic effects of radiotherapy, and we want to understand how they work. This knowledge will further the development of this innovative approach for the treatment of cancer patients who are resistant to immune checkpoint inhibitors."

The company received the FDA's approval to launch a clinical study of NBTXR3 activated by radiotherapy in combination with anti-PD1 antibody in lung, and head and neck cancer patients (head and neck squamous cell carcinoma and non small cell lung cancer). This trial that shall start in Q2 2018, aims to expand the potential of NBTXR3, including using it to treat recurrent or metastatic disease.

Many IO combination strategies focus on 'priming' the tumor, which is now becoming a prerequisite of turning a "cold" tumor into a "hot" tumor.

Compared to other modalities that could be used for priming the tumor, NBTXR3 could have a number of advantages: the physical and universal mode of action that could be used widely across oncology, a one-time local injection and good fit within existing medical practice already used as a basis for cancer treatment, as well as a very good chronic safety profile and well-established manufacturing process. Published preclinical and clinical data indicate that NBTXR3 could play a key role in oncology and could become a backbone in immuno-oncology.

Nanobiotix's immuno-oncology combination programme opens the door to new developments, potential new indications, and important value creation opportunities.

NBTXR3 is a first-in-class product designed to destroy, when activated by radiotherapy, tumors and metastasis through physical cell death and to immunogenic cell death leading to specific activation of the immune system. NBTXR3 has a high degree of biocompatibility, requires one single administration before the whole radiotherapy treatment and has the ability to fit into current worldwide standards of radiation care. NBTXR3 is being evaluated in head and neck cancer (locally advanced squamous cell carcinoma of the oral cavity or oropharynx), and the trial targets frail and elderly patients who have advanced cancer with very limited therapeutic options. The phase I/II trial has already delivered very promising results regarding the local control of the tumors and a potential metastatic control through in situ vaccination.