PARIS & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Regulatory News:
NANOBIOTIX (Paris:NANO) (Euronext : NANO – ISIN : FR0011341205 – the ‘‘Company’’) today announced updates to the Company’s operational and global development plan in light of the COVID-19 crisis. To protect the interests of employees, patients, partners, and shareholders, Nanobiotix has made organizational adjustments to control costs and is in active discussions regarding non-dilutive financing options—both public and private.
Regarding clinical development, priorities are unchanged. The Company remains in position to deliver data from its priority pathways in head and neck cancer and immuno-oncology (I/O) on schedule. While recruitment and monitoring have slowed due to the crisis, delivery of data in these areas will proceed as planned based on patients already recruited.
The following breakdown provides an update on the Global Development Plan released on January 7, 2020:
Priority Development in Head and Neck Cancer and Immuno-Oncology
Pathway to Global Registration in Head and Neck Cancer On Track
Global registration of NBTXR3, particularly in the United States (US) and Europe (EU), remains the top development priority for Nanobiotix. Preliminary efficacy and safety data from Study 102 Expansion—the expansion part of the Company’s phase I trial evaluating NBTXR3 activated by radiation therapy for elderly and frail patients ineligible for platinum-based chemotherapy (cisplatin)—will be presented at the annual meeting of the American Society for Clinical Oncology (ASCO) scheduled May 29th to May 31st 2020.
As previously announced, the design of Study 312–a phase III investigator’s choice, dual-arm, randomized (1:1) global registration trial including elderly head and neck cancer patients ineligible for cisplatin—is currently under review by the U.S. Food and Drug Administration (FDA). Once approved, the trial will launch as soon as the requisite financing is secured
First Clinical Data in I/O to be Presented Soon
In addition to the registration pathway in head and neck cancer, evaluation of the potential for NBTXR3 as a pillar of the I/O treatment paradigm is the Company’s second key priority. Although recruitment has been impacted by the global pandemic, Study 1100–an I/O basket trial in the US evaluating NBTXR3 activated by radiation therapy in combination with anti-PD-1 in patients with head and neck cancer, lung metastasis and/or liver metastasis—remains on track to report first new data on patients already recruited within the next few months.
Early-Stage Development Across Other Indications and with Collaborators
Nanobiotix Trials in Additional Indications
The dose escalation part of Study 103–a phase I trial evaluating NBTXR3 activated by radiation therapy for the treatment of patients with hepatocellular carcinoma (HCC) and liver metastasis—is complete and final data will be shared by the end of the year. Crisis-related trial monitoring and recruitment restrictions are driving the delay in delivery of data.
The status of Study 104—a phase I trial evaluating NBTXR3 activated by radiation therapy for the treatment of patients with prostate cancer— is currently under review and updates will be provided in due time.
In soft tissue sarcoma, further follow up of patients from Act.In.Sarc remains ongoing, however the timeline will extend to account for hospital restrictions and monitoring barriers. Launch of the planned post-registrational trial in soft tissue sarcoma will be pushed from the second half of 2020 to Q2 2021. This will have no impact on the global development of the product, business and company other than postponing some expenses.
Trials with Collaborators
New data from the previously announced pre-clinical collaboration with The University of Texas MD Anderson Cancer Center (MD Anderson) has been delayed due to shifting congress schedules, but should be presented later in 2020.
Clinical trials from the Company’s clinical collaboration with MD Anderson are moving through the regulatory review process. Given recruitment barriers, the Company expects delays in execution after regulatory approval.
Regarding the Company’s clinical collaboration with PharmaEngine in Asia, Nanobiotix understands from its partner that the phase I head and neck trial is expected to complete recruitment by the end of 2020. PharmaEngine has also indicated it is on pace to fully enroll the rectal study—evaluating NBTXR3 in combination with chemotherapy—by the end of 2020 as well.
Additional updates will be delivered once the Company has clearer visibility on the operational impact of systemic healthcare restrictions in the coming months.
NBTXR3 is a first-in-class product designed to destroy tumors through physical cell death when activated by radiotherapy. NBTXR3 has a high degree of biocompatibility, requires one single administration before the first radiotherapy treatment session, and has the ability to fit into current worldwide standards of radiation care. The physical mode of action of NBTXR3 makes it applicable across solid tumors such as lung, prostate, liver, glioblastoma, and breast cancers.
About NANOBIOTIX: www.nanobiotix.com
Incorporated in 2003, Nanobiotix is a leading, clinical-stage nanomedicine company pioneering new approaches to significantly change patient outcomes by bringing nanophysics to the heart of the cell.
The Nanobiotix philosophy is rooted in designing pioneering, physical-based approaches to bring highly effective and generalized solutions to address unmet medical needs and challenges.
Nanobiotix’s first-in-class, proprietary lead technology, NBTXR3, aims to expand radiotherapy benefits for millions of cancer patients. Nanobiotix’s Immuno-Oncology program has the potential to bring a new dimension to cancer immunotherapies.
Nanobiotix is listed on the regulated market of Euronext in Paris (Euronext: NANO / ISIN: FR0011341205; Bloomberg: NANO: FP). The Company’s headquarters are in Paris, France, with a U.S. affiliate in Cambridge, MA, and European affiliates in France, Spain and Germany
This press release contains certain forward-looking statements concerning Nanobiotix and its business, including its prospects and product candidate development. Such forward-looking statements are based on assumptions that Nanobiotix considers to be reasonable. However, there can be no assurance that the estimates contained in such forward-looking statements will be verified, which estimates are subject to numerous risks including the risks set forth in the reference document of Nanobiotix registered with the French Financial Markets Authority (Autorité des Marchés Financiers) under number R.19-018 on April 30, 2019 (a copy of which is available on www.nanobiotix.com) and to the development of economic conditions, financial markets and the markets in which Nanobiotix operates. The forward-looking statements contained in this press release are also subject to risks not yet known to Nanobiotix or not currently considered material by Nanobiotix. The occurrence of all or part of such risks could cause actual results, financial conditions, performance or achievements of Nanobiotix to be materially different from such forward-looking statements.