On November 12, 2019 NANOBIOTIX (Paris:NANO) (Euronext : NANO – ISIN : FR0011341205 – the ‘‘Company’’) reported promising results from its pre-clinical collaboration1 with The University of Texas MD Anderson Cancer Center (Press release, Nanobiotix, NOV 12, 2019, View Source [SID1234551000]). The research, which evaluated first-in-class radioenhancer NBTXR3 activated by radiation therapy in combination with anti-PD-1 and anti-CTLA-4 immune checkpoint inhibitors, was presented last week at the 2019 Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper).
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Combination of a radiation-enhancing nanoparticle, radiotherapy, and immune checkpoint inhibitors for treating metastasized lung cancer in mice – SITC (Free SITC Whitepaper) 2019 Poster – 508
Yun Hu1, Sébastien Paris2, Hampartsoum B. Barsoumian1, Mark Wasley1, Ahmed Younes1, DaweiChen1, Liang P. Yang1, Fatemeh Masrorpour1, Maria Angelica Cortez1, James W. Welsh1
1 Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA
2 Nanobiotix, Department of Translational Science, Paris, France
This pre-clinical research studied NBTXR3 activated by radiation therapy in combination with anti-PD-1 in immunocompetent mice bearing an anti-PD-1 resistant tumor on each flank—only one tumor on each mouse was irradiated. According to the data from this model, the combination treatment that included NBTXR3 and anti-PD-1 increased local control of the irradiated tumor, generated a marked abscopal effect, decreased the number of spontaneous lung metastases, and significantly increased survival when compared to other treatments in the study including anti-PD-1 combined with radiation therapy alone.
The results also show that the combination that included NBTXR3 and anti-PD-1 has the potential to achieve an equivalent abscopal effect at a lower dose of radiation. This opens the possibility for radiation de-escalation, meaning the amount of radiation therapy could be reduced without decreasing efficacy.
Additionally, the study included an in vivo RadScopal model where the second tumor received a low dose of radiation while the first tumor received a full dose. In the RadScopal model, researchers evaluated NBTXR3 activated by radiation therapy combined with anti-PD-1 and anti-CTLA-4. The data show that this combination triggered superior local control along with significant increases in abscopal effect and survival when compared to all other tested combinations. Several complete responses were observed in the second tumor of the group that received the NBTXR3 combination while none were observed in the other groups.
These results could pave the way for the use of NBTXR3 to improve treatment outcomes for immuno-oncology patients, including checkpoint inhibitor non-responders.
About NBTXR3
NBTXR3 is a first-in-class product designed to destroy tumors through physical cell death when activated by radiotherapy. NBTXR3 has a high degree of biocompatibility, requires one single administration before the first radiotherapy treatment session, and has the ability to fit into current worldwide standards of radiation care. The physical mode of action of NBTXR3 makes it applicable across solid tumors such as lung, prostate, liver, glioblastoma, and breast cancers.
NBTXR3 is actively being evaluated in head and neck cancer with locally advanced squamous cell carcinoma of the oral cavity or oropharynx in elderly and frail patients unable to receive chemotherapy or cetuximab with limited therapeutic options. Promising results have been observed in the phase I/II trial regarding local control. In the United States, based on discussions with the Food and Drug Administration (FDA) that occurred in the first half of 2019, the Company plans to begin the clinical trial authorization process in the second half of 2019 and commence a phase II/III clinical trial in locally advanced head and neck cancers.
Nanobiotix is also running an Immuno-Oncology development program. The Company received approval FDA to launch a clinical trial of NBTXR3 activated by radiotherapy in combination with anti-PD-1 antibodies in locoregional recurrent (LRR) or recurrent and metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) and lung or liver metastasis (mets) with HNSCC not amenable to re-irradiation or non-small cell lung cancer (NSCLC) as the primary tumor .
The other ongoing NBTXR3 trials 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. Furthermore, the company has a large-scale, comprehensive clinical research collaboration with MD Anderson (9 new phase I/II clinical trials in the United States) to evaluate NBTXR3 across head and neck, pancreatic, thoracic, lung, gastrointestinal and genitourinary cancers.