On May 3, 2018 NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, reported that it is launching a research collaboration with Weill Cornell Medicine to begin nonclinical studies of NBTXR3’s mechanism of action (Press release, Nanobiotix, MAY 3, 2018 View Source [SID1234526080]). 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.

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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 cGASSTING
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 antitumor
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 proimmunogenic
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 nonsmall 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.
NBTXR3 positioning in IO
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 program opens the door to new developments, potential new
indications, and important value creation opportunities.
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About NBTXR3
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.
Nanobiotix is running an Immuno-Oncology program with NBTXR3 that includes several studies. In the U.S., the Company received
the FDA’s approval to launch a clinical study of NBTXR3 activated by radiotherapy in combination with anti-PD1 antibodies in lung,
and head and neck cancer patients (head and neck squamous cell carcinoma and non-small cell lung cancer). This trial aims to
expand the potential of NBTXR3, including using it to treat recurrent or metastatic disease.
The first market authorization process (CE Marking) is ongoing in Europe in the soft tissue sarcoma indication.
The other ongoing studies are treating patients with liver cancers (hepatocellular carcinoma and liver metastasis), locally advanced
or unresectable rectal cancer in combination with chemotherapy, head and neck cancer in combination with concurrent
chemotherapy, and prostate adenocarcinoma.