- Recommended dose for the phase 2 dose escalation portion of Study 1100, established at 33% tumor volume (GTV) in all three study cohorts.
- Updated clinical data from Study 1100 is expected in Q4 2022.
- Submission to the US Food and Drug Administration (FDA) of a Phase 3 protocol evaluating NBTXR3 in combination with anti-PD-1 for head and neck cancer patients is planned for the first quarter of 2023.
PARIS & CAMBRIDGE, MA–(BUSINESS WIRE)–Regulatory news:
NANOBIOTIX (Euronext: NANO –– NASDAQ: NBTX – “ Company ), a late-stage biotech company pioneering physics-based approaches to expand treatment options for cancer patients, today announces that it has established a recommended dose phase 2 (RP2D) study combining NBTXR3 with pembrolizumab or nivolumab in the treatment of unresectable, locoregional recurrent (LRR) or immunotherapy-resistant recurrent and metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). RP2Ds were determined for NBTXR3 plus pembrolizumab or nivolumab in patients with: immunotherapy-naïve LRR or R/M HNSCC, lung or liver metastases from any primary tumor.
The dose escalation and extension phases of Study 1100 are expected to enroll a total of up to 141 patients. The dose-escalation phase, now completed, included 29 patients in three cohorts: (i) head and neck lesions of LRR or R/M HNSCC eligible for anti-PD therapy -1; (ii) lung 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, followed by anti-PD-1. Based on the results of this study, RP2D for the three cohorts was determined to be 33% of tumor volume.
Nanobiotix’s goal is 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 do so, the Company modified the ongoing expansion phase of Study 1100 to strengthen the hypothesis of a protocol evaluating NBTXR3 associated with anti-PD-1 in patients with immunotherapy-resistant recurrent and metastatic head or neck cancer.
The revised protocol for the dose-expansion phase of Study 1100 also includes three cohorts, which, however, have been redesigned to provide more clinical evidence in several immunotherapy-eligible indications, including patients with HNSCC LRR or R/M who were naïve or resistant to immunotherapy. Expansion phase cohorts were divided as follows: (i) immunotherapy-resistant HNSCC LRR or R/M; (ii) HNSCC LRR or R/M that have never been treated with immunotherapy; (iii) lung, liver, or soft tissue metastases from inoperable 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 present updated clinical data from study 1100 in the fourth quarter of 2022. The protocol submission for the phase 3 study is expected in the first quarter of 2023, followed by a modification of the study design.
NBTXR3 is a new 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 product candidate’s physical mechanism of action is designed to induce tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering an adaptive immune response and long-term anti-cancer memory. Given the physical mechanism of action, Nanobiotix believes that NBTXR3 may be suitable for solid tumors that can be treated with radiotherapy and various therapeutic combinations.
Nanobiotix is a clinical 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 committed to making a difference for humanity. The company is using 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 cancers.
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 may be identified by words such as “in at this time”, “anticipate”, “believe”, “expect”, “intend”, “on the way”, “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 data presentations, the results of our preclinical and clinical studies and their potential implications. These forward-looking statements are made in light of information currently available to us and based on assumptions that Nanobiotix believes to be reasonable. However, these forward-looking statements are subject to a number of risks and uncertainties, including the risk that subsequent studies and ongoing or future clinical trials may not generate favorable data despite positive preclinical results and risks associated with the developing nature. the duration and severity of the COVID-19 pandemic and the governmental and regulatory measures implemented in response to it, the risk of not reaching a final agreement with the EIB on the announced restructuring; the risk that the EIB may benefit from early payment caused by events of default specified in the contractual documentation, the risk that the Company may not have access to additional capital on attractive terms. In addition, numerous other material risks and uncertainties, including those described in our Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission on April 8, 2022 under “Item 3.D. Risk Factors” and those set forth in Nanobiotix’s universal registration document filed with the Autorité des marchés financiers on April 8, 2022 (a copy of which is available at www.nanobiotix.com), may adversely affect these forward-looking statements and cause our actual results, performance or achievements to differ materially from those expressed or implied in the forward-looking statements. Except as required by law, we undertake no obligation to publicly update these forward-looking statements or to update any reasons that could cause actual results to differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.
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