NANOBIOTIX to Present First Survival Data from Priority Head and Neck Cancer Program Among Five Presentations at 2021 American Society for Radiation Oncology Annual Meeting
PARIS & CAMBRIDGE, Mass .– (COMMERCIAL THREAD) – Regulatory news:
NANOBIOTIX (Euronext: NANO – NASDAQ: NBTX – the ”Society”), an advanced clinical biotechnology company pioneering physics-based approaches to expand treatment options for cancer patients, today announced two oral presentations and three poster presentations at the 2021 annual meeting of the American Society for Radiation Oncology (ASTRO). The meeting will be held from October 24-27, 2021.
âProviding disruptive therapeutic solutions that expand treatment options for cancer patients begins with having a significant impact on survival,â said Laurent Levy, co-founder and Chairman of the Board of Directors of Nanobiotix. âDelivering the first insight into these exploratory endpoints in our Phase I head and neck cancer study will provide useful insight into the potential of our innovation in our priority indication as we prepare to launch our phase World III. As we continue to develop NBTXR3 as a potential therapy widely applicable to solid tumor types and combination therapy in parallel, we also look forward to providing updates in immunotherapy and soft tissue sarcoma. ”
Oral and poster presentation details:
Local control with NBTXR3 as monotherapy for patients with head and neck cancer
- Poster presentation # 2805: Phase I study of the new radiotherapy-activated NBTXR3 radio amplifier in patients with locally advanced HNSCC ineligible for cisplatin by Christophe Le Tourneau, MD, PhD, October 26 at 1:15 p.m. CDT / 8:15 p.m. CET
NBTXR3 Tumor agnostic development potential, combination therapy and agnostic
- Oral presentation # 132: Overcoming Anti-PD-1 Resistance with Tumor Agnostic NBTXR3: Bench-to-Bedside by Tanguy Y. Seiwert, MD, October 26 at 4:20 p.m. CDT / 11:20 p.m. CET
Priming of the immune response with NBTXR3 plus Anti-PD-1 in advanced cancers
- Presentation of poster # 2739: NBTXR3 activated by radiotherapy in combination with nivolumab or pembrolizumab in patients with advanced cancers: a phase I trial by Colette Shen, MD, PhD, October 25 at 4:00 p.m. CDT / 11:00 p.m. CET
Local control with NBTXR3 monotherapy for patients with soft tissue sarcoma
- Oral presentation # 77: Study of New NBTXR3 Plus Radiation Therapy with the Radioenhancer in Patients with Locally Advanced Soft Tissue Sarcoma: Results of the Long-Term Evaluation of the Act.In.Sarc Phase II / III Trial by Sylvie Bonvalot, MD, PhD, October 26 at 5:15 p.m. CDT / 12:15 a.m. CET
Preclinical data on NBTXR3 plus Anti-PD-1 in the lung cancer model
- Poster presentation # 2865: NBTXR3 Nanoparticle with ImmunoRadiation Could Reshape Tumor-Infiltrating Metastatic T Cell Repertoire in Murine Lung Cancer Model by Chike O. Abana, MD, PhD, October 26, 3:30 p.m. CDT / 10:30 p.m. CET
NBTXR3 is a potentially first-in-class new oncology product comprised of functionalized hafnium oxide nanoparticles that are delivered by single intratumoral injection and activated by radiation therapy. The physical mechanism of action (MoA) of the candidate product is designed to induce significant 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 MoA, Nanobiotix believes that NBTXR3 could be scalable in any solid tumor that can be treated with radiation therapy and in any combination therapy, especially immune checkpoint inhibitors.
NBTXR3 is being evaluated in locally advanced squamous cell carcinoma of the head and neck (HNSCC) as a major development pathway. The company sponsored Phase I dose escalation and extension study produced favorable safety data and early signs of efficacy; and a phase III global registration study is expected to be launched in 2021. In February 2020, the United States Food and Drug Administration granted Fast Track regulatory designation for the study of radiotherapy-activated NBTXR3, with or without cetuximab , for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy – the same population being assessed in the planned phase III study.
Nanobiotix has also prioritized a development program in immuno-oncology, starting with a Company-sponsored Phase I clinical study evaluating radiotherapy-activated NBTXR3 in combination with anti-PD-1 checkpoint inhibitors for patients with recurrent or recurrent / metastatic locoregional HNSCC and pulmonary or hepatic metastases. any primary cancer eligible for anti-PD-1 treatment.
Given the areas of focus of the Company and the scalable potential of NBTXR3, Nanobiotix has embarked on a strategy of strategic collaboration with world-class partners to expand the development of the product candidate alongside its priority development paths. As part of this strategy, Nanobiotix entered into a large and comprehensive clinical research collaboration in 2019 with the MD Anderson Cancer Center at the University of Texas to sponsor several phase I and phase II studies to evaluate NBTXR3 through types of tumors and therapeutic combinations.
Nanobiotix is ââan advanced clinical biotechnology company developing disruptive physics-based therapeutic approaches to revolutionize treatment outcomes for millions of patients; supported by people committed to making a difference for humanity. The company’s philosophy is rooted in the concept of pushing the boundaries of what is known to expand the possibilities of human life. Established in 2003, Nanobiotix is ââheadquartered in Paris, France. The company also has subsidiaries in Cambridge, Massachusetts (United States), France, Spain and Germany. Nanobiotix has been listed on the regulated market of Euronext in Paris since 2012 and on the Nasdaq Global Select Market in New York since December 2020. Nanobiotix owns more than 30 umbrella patents associated with three (3) nanotechnology platforms with applications in 1) oncology; 2) bioavailability and biodistribution; and 3) central nervous system disorders. The company’s resources are mainly devoted to the development of its flagship product candidate, NBTXR3, which is the product of its proprietary oncology platform and has already obtained marketing authorization in Europe for the treatment of patients with sarcoma. soft tissue under the HensifyÂ® brand. For more information on 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 may be identified by words such as “at this time”, “anticipate “,” Believe “,” expect “,” intend “,” on the right track “,” plan “,” foresee “and” will “, or the negative of these expressions and the like. These forward-looking statements, which are based on our management’s current expectations and assumptions and on information currently available to management, include statements about the timing and progress of clinical trials, the timing of our data presentation, the results of our preclinical studies and their potential implications. These forward-looking statements are made in light of the information currently available to us and on the basis of assumptions that Nanobiotix considers to be reasonable. However, these forward-looking statements are subject to many risks and uncertainties, particularly with respect to the risk associated with the evolving nature of the duration and severity of the COVID-19 pandemic and the government and regulatory measures implemented to address it. answer to. In addition, many other important factors, including those described in our Annual Report on Form 20-F filed with the United States Securities and Exchange Commission (the SEC) on April 7, 2021 under âSection 3.D . Risk factors âand those set out in the universal registration document of Nanobiotix filed with the AutoritÃ© des marchÃ©s financiers (AMF) on April 7, 2021, as updated in our half-year financial report filed with the AMF and SEC on September 8, 2021 (a copy of which is available at www.nanobiotix.com) and other known and unknown risks and uncertainties may adversely affect these forward-looking statements and cause our results, performance or actual accomplishments be materially different from those expressed or implied by forward-looking statements. Except as required by law, we assume no obligation to update these forward-looking statements publicly, 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.