NANOBIOTIX announced the reporting of new data at the 2022 Annual Meeting of the American Society for Clinical Oncology (ASCO) featuring potential first-in-class radioenhancer NBTXR3 in combination with concurrent chemoradiation for the treatment of head and neck cancer and rectal cancer. Nanobiotix also presented a trial-in-progress poster on the study design of the Company's ongoing pivotal phase 3 study, NANORAY-312, evaluating NBTXR3 as a single agent activated by radiotherapy for the treatment of elderly and frail patients with locally advanced head and neck squamous cell carcinoma (LA-HNSCC) who are ineligible for platinum-based chemotherapy (cisplatin). In view of the Company's strategy for development of NBTXR3 as a product candidate that can integrate across solid tumor indications along with major treatment modalities within each indication, starting with head and neck cancer, the company believes these new data add support for the radioenhancer in combination with chemoradiation and as a neoadjuvant (preoperative) therapy with the potential to improve surgical outcomes. "Revolutionizing treatment outcomes for millions of patients with cancer will require integration of NBTXR3 across solid tumor indications, treatment modalities, and lines of therapy where radiation is a part of the treatment regimen—starting with head and neck cancer. Most cisplatin-eligible patients with LA-HNSCC receive multimodal therapy including high dose concurrent chemoradiation (CCRT) as the standard of care. While CCRT has shown to improve local control and extend survival, the toxicity of high dose cisplatin creates challenges. These challenges appear both in terms of compliance with the treatment regimen for patients undergoing therapy that can impair efficacy, and in terms of the patients' quality of life after treatment. Although changes to the treatment protocol have been explored in randomized studies to reduce toxicity and improve compliance, reduction in toxicity has also led to reduction in efficacy. These patients need innovative new therapeutic options that do not create additional burden in their administration, do not add combined toxicity to radiotherapy and chemotherapy, and have the potential to improve survival. This study, sponsored, executed, and reported by former Nanobiotix collaborator in Asia, PharmaEngine Inc. (PEI), sought to evaluate the safety and feasibility of NBTXR3 intratumoral injection when added to low-dose weekly cisplatin-containing CCRT for patients with locally advanced or recurrent head and neck squamous cell carcinoma. The study also aimed to establish the recommended phase 2 dose (RP2D), however the RP2D was not determined due to stoppage of the phase 1b part of the trial resulting from the conclusion of the collaboration between PEI and Nanobiotix in 2021. Adult patients with T3-4 LA-HNSCC suitable for cisplatin were eligible for the study and 12 such patients were enrolled. These patients received a single intratumoral injection of NBTXR3, followed by a low-dose weekly regimen of CCRT. All 12 patients were deemed evaluable and all had stage 4 locally advanced disease.