Recommended phase 2 dose set at 33% of gross tumor volume in all three cohorts from the full escalation portion of Study 1100
Updated clinical data from Study 1100 expected in Q4 2022
Protocol submission to the U.S. Food and Drug Administration for a Phase 3 clinical trial evaluating NBTXR3 in combination with anti-PD-1 in head and neck cancer patients is expected in Q1 2023
PARIS & CAMBRIDGE, Mass., September 21, 2022–(BUSINESS WIRE)–Regulatory News:
NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – the ”company”), a late clinical-stage biotechnology company pioneering physics-based approaches to expand treatment options for cancer patients, today announced the determination of the Phase 2 Recommended Dose (RP2D) of NBTXR3 in combination with pembrolizumab or nivolumab for the treatment of Patients known to have unresectable locoregionally recurrent (LRR) or recurrent and metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) resistant to prior immunotherapy. RP2Ds were determined for NBTXR3 plus pembrolizumab or nivolumab for patients with LRR or R/M HNSCC who have not received prior immunotherapy, pulmonary metastases (Mets) from a primary tumor, or liver Mets from a primary tumor.
The combined dose escalation and dose expansion portions of Study 1100 are expected to enroll up to 141 patients. The full dose escalation part included 29 patients in three cohorts: (i) head and neck lesions of LRR or R/M HNSCC eligible for anti-PD-1 therapy; (ii) lung metastases from any primary cancer amenable to anti-PD-1 therapy; and (iii) liver Mets from any primary cancer amenable to anti-PD-1 therapy. Study participants received a single intratumoral injection of NBTXR3 prior to their first radiation session. They then received radiation therapy followed by anti-PD-1. Based on the results of the study, the RP2D was set at 33% of the gross tumor volume for all three cohorts.
Nanobiotix aims to offer a best-in-class head and neck cancer treatment franchise based on NBTXR3 and expand this approach to other solid tumor indications. In line with this strategy, the Company has modified the ongoing expansion phase of Study 1100 to further strengthen the rationale for an enrollment protocol to evaluate NBTXR3 plus anti-PD-1 in patients with R/M HNSCC resistant to prior immunotherapy.
The modified dose-expansion portion of Study 1100 also includes three cohorts, but the cohorts were redesigned to further investigate NBTXR3 plus anti-PD-1 in multiple immunotherapy-candidate indications, with a particular focus on treating patients with LRR or R/M HNSCC primary lesions that are either naïve or resistant to prior immunotherapy. The extension part cohorts are as follows: (i) LRR or R/M HNSCC resistant to prior immunotherapy; (ii) LRR or R/M HNSCC that has not received prior immunotherapy; (iii) Lung, liver or soft tissue from inoperable NSCLC, malignant melanoma, hepatocellular carcinoma, renal cell carcinoma (RCC), urothelial cancer, cervical cancer or triple negative breast cancer (TNBC) primary tumors.
The Company expects to provide updated clinical data from Study 1100 in Q4 2022. Submission of the Phase 3 registration protocol is expected in Q1 2023, followed by a study design change.
NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles delivered via a single intratumoral injection and activated by radiation therapy. The physical mechanism of action (MoA) of the product candidate is designed such that, when activated by radiation therapy, it induces significant tumor cell death in the injected tumor and subsequently induces an adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes NBTXR3 could be scalable across solid tumors that can be treated with radiotherapy and across different therapeutic combinations.
Nanobiotix is a late-stage clinical biotechnology company developing pioneering physics-based therapeutic approaches to revolutionize patient outcomes for millions of patients; supported by people committed to making a difference for humanity. The Company is leveraging its proprietary nanoparticle platform, including its lead product candidate, radiotherapy-activated NBTXR3, to develop a pipeline of therapeutic options aimed at improving local and systemic control of solid tumors, with an initial focus on the treatment of head and neck cancer lies.
For more information about Nanobiotix, visit us at www.nanobiotix.com or follow us on LinkedIn and Twitter.
This press release contains certain “forward-looking” statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements are identified by words such as “current”, “anticipate”, “believe”, “expect”, “intend”. ‘, ‘in plan’, ‘plan’, ‘scheduled’ and ‘will’ or the negation of these and similar expressions. These forward-looking statements, which are based on management’s current expectations and assumptions and information currently available to management, include statements about the timing and progress of clinical studies, the timing of our presentation of data, the results of our preclinical and clinical studies Studies and their possible implications. Such forward-looking statements are made in light of the information currently available to us and are based on assumptions that Nanobiotix believes to be reasonable. However, these forward-looking statements are subject to numerous risks and uncertainties, including the risk that subsequent trials and ongoing or future clinical trials may fail despite positive early clinical results and the risks associated with the evolving nature of the duration and severity of the COVID-19 pandemic and as Official and regulatory measures taken in response thereto, the risk that the Company and the EIB will not reach final agreement on the restructuring of the loan; the risk that the EIB may accelerate loans under the Finance Agreement and its modification should normal default events occur; the risk that the company is unable or unable to raise additional capital on attractive terms. In addition, many other important risk factors and uncertainties, including those described in our Annual Report on Form 20-F filed with the United States Securities and Exchange Commission on April 8, 2022, under “Item 3.D. Risk Factors” were those listed in Nanobiotix’s universal registration document filed with the French Financial Markets Authority (Autorité des Marchés Financiers – AMF) on 08.08 www.nanobiotix.com), may adversely affect such forward-looking statements and cause our actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements. Except as required by law, we undertake no obligation to publicly update these forward-looking statements or to update the reasons why actual results may differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.
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