- Recommended dose for the phase 2 portion of the 1100 dose-escalation study, set at 33% tumor volume (GTV) in all three study cohorts.
- Updated clinical data from study 1100 is expected in Q4 2022.
- A Phase 3 protocol evaluating NBTXR3 in combination with anti-PD-1 for patients with head and neck cancer (FDA) is scheduled to be submitted to the US Food and Drug Administration in the first quarter of 2023.
PARIS & CAMBRIDGE, Mass. – (BUSINESS WIRE) – Regulatory News:
NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – “ Company ), a late-stage biotech company pioneering physical approaches to expand treatment options for cancer patients, today announces that it has initiated a recommended-dose Phase 2 (RP2D) study combining NBTXR3 with pembrolizumab or nivolumab in the treatment of inoperable patients with locoregional recurrent ( LRR) or recurrent and metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) resistant to immunotherapy. RP2Ds were established for NBTXR3 plus pembrolizumab or nivolumab in patients with: immunotherapy-naïve LRR or R/M HNSCC, lung or liver metastases from any primary tumor.
A total of up to 141 patients are expected to be enrolled in the dose escalation and expansion phases of Study 1100. The dose escalation phase, now completed, included 29 patients in three cohorts: (i) head and neck lesions from LRR or R/M HNSCC eligible for anti-PD therapy -1; (ii) pulmonary metastases from any primary cancer amenable to anti-PD-1 therapy; and (iii) liver metastases from any primary cancer amenable to anti-PD-1 therapy. Study participants received a single intratumoral injection of NBTXR3 before the first session of radiation therapy. They then received radiotherapy, then anti-PD-1. Based on the results of this study, the RP2D for the three cohorts was determined to be 33% of the tumor volume.
Nanobiotix aims to provide a cutting-edge solution and future standard of care for NBTXR3-based head and neck cancer and to adopt this approach for other types of solid tumors. To this end, the company modified the ongoing extension phase 1100 study to strengthen the hypotheses of the protocol evaluating NBTXR3 combined with anti-PD-1 in patients with immunotherapy-resistant head or recurrent and metastatic neck cancer.
The revised protocol for the dose expansion phase of study 1100 also includes three cohorts, but has been revised to provide more clinical evidence in several indications suitable for immunotherapy, including patients with LRR or R/M HNSCC previously untreated or resistant to immunotherapy. The expansion phase cohorts are divided as follows: (i) HNSCC LRR or R/M resistant to immunotherapy; (ii) HNSCC LRR or R/M who have never been treated with immunotherapy; (iii) lung, liver, or soft tissue metastases from unresectable non-small cell lung cancer (NSCLC), malignant melanoma, hepatocellular carcinoma, renal cell carcinoma (RCC), urothelial carcinoma, cervical cancer, or triple-negative breast cancer.
The company expects to submit updated clinical data from study 1100 in the fourth quarter of 2022. A protocol submission for the Phase 3 study is expected in the first quarter of 2023, followed by a study design adjustment.
NBTXR3 is a novel oncology product, potentially the first in its class, composed of functionalized hafnium oxide nanoparticles. NBTXR3 is administered by a single intratumoral injection and activated by radiotherapy. The physical mechanism of action of the product candidate is designed to induce tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering an adaptive immune response and anti-cancer long-term memory. Due to the physical mechanism of action, Nanobiotix believes that NBTXR3 could be suitable for solid tumors that can be treated with radiotherapy and various therapeutic combinations.
Nanobiotix is a clinical-stage and late-stage biotechnology company developing innovative physics-based therapeutic approaches to revolutionize treatment benefits for millions of patients; it is supported by people who are determined to change humanity. The company is leveraging its proprietary nanoparticle platform, particularly its radiotherapy-activated lead product candidate NBTXR3, to develop a range of therapeutic options aimed at improving local and systemic control of solid tumors starting with head and neck cancer.
For more information about Nanobiotix, visit 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 can be identified by words such as “currently,” “anticipate,” “believe.” , “expect”, “intend”, “on track”, “plan”, “plan” and “will”, or the negative of these and other similar expressions. These forward-looking statements, which are based on our management’s current expectations and assumptions and information currently available to it, include statements about the timing and progress of clinical trials, the timing of the presentation of our data, the results of our preclinical and clinical studies and their potential consequences. These forward-looking statements are made based on information currently available to us and 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 studies and ongoing or future clinical trials may not yield favorable data despite positive preclinical results and risks associated with the evolving nature, duration and severity of the COVID-19 pandemic and governmental and regulatory actions taken in response to it, the risk of not reaching a definitive agreement with the EIB on the announced restructuring; the risk that the EIB may benefit from an early payment caused by cases of non-fulfillment of the obligations specified in the contractual documentation, the risk that the company will not have access to additional capital on attractive terms. In addition, there are a number of other significant risks and uncertainties, including those described in our Annual Report on Form 20-F filed with the US Securities and Exchange Commission on April 8, 2022 under “Item 3.D. risk factors’ and those listed in Nanobiotix’s universal registration document filed with the Autorité des marchés financiers on April 8, 2022 (a copy is available at www.nanobiotix.com), could adversely affect these forward-looking statements and cause our actual results, performance or achievements to differ materially from those expressed or implied by these 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 could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.
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