After the achievement of major development milestones in 2019, 2020 offers great opportunity for Nanobiotix and NBTXR3 to fulfill unmet patient needs across oncology. Given NBTXR3s universal mode of action, our proof-of-concept in soft tissue sarcoma, and promising results from our phase I trial in head and neck cancers, we are confident that NBTXR3 activated by radiation therapy has the potential to significantly improve treatment outcomes for head and neck cancer patients. Beyond head and neck, we will continue to expand into additional indications and combination therapies. Ultimately, we aim to change the oncology treatment paradigm for millions of patients around the world. Laurent Levy, CEO of Nanobiotix<\/p>\n
NANOBIOTIX (Euronext : NANO ISIN : FR0011341205 the Company) today announced its global development strategy for 2020 and beyond, following proof-of-concept (POC) and European market approval for NBTXR3 in locally advanced soft tissue sarcoma of the extremities and trunk wall (Brand Name: Hensify) in 2019. The Company will continue to prioritize its registration pathway in the US and EU for the treatment of head and neck cancers, while also working to advance the Nanobiotix immuno-oncology (I\/O) program and evaluate NBTXR3 in other indications such as lung, pancreatic, esophageal, hepatocellular carcinoma (HCC), prostrate, and rectal cancers. To execute this plan, Nanobiotix will focus on H&N cancers while its collaborators (i.e. The University of Texas MD Anderson Cancer Center (MD Anderson) in the US and PharmaEngine in Asia) are working on other indications.<\/p>\n
Global Development Plan Visualization<\/p>\n
TRIAL<\/p>\n
STATUS<\/p>\n
ANTICIPATED NEXT STEPS<\/p>\n
Development in Head and Neck Moving Forward<\/p>\n
Phase III Registration Trial for NBTXR3 in head and neck patients ineligible for cisplatin<\/p>\n
TRIAL NAME: STUDY 312<\/p>\n
Nanobiotix trial <\/p>\n
Design completed based on last interactions with FDA and European payers (EUnetHTA)<\/p>\n
Jan 2020 - Submission of final protocol to FDA and other global regulatory bodies<\/p>\n
Phase I and Phase I Expansion Trial for NBTXR3 in head and neck patients ineligible for cisplatin or intolerant to cetuximab<\/p>\n
TRIAL NAME: Study 102\/ 102 Expansion<\/p>\n
Nanobiotix trial<\/p>\n
Phase I dose escalation completed \/ data reported 19 patients<\/p>\n<\/p>\n
Dose Expansion 38 of 44 patients recruited<\/p>\n
Q1 2020 - Update of dose escalation patients follow-up<\/p>\n<\/p>\n
Mid 2020 - First expansion phase data on efficacy and safety of dose expansion<\/p>\n
Phase I\/II Trial for NBTXR3 combined with cisplatin for head and neck patients<\/p>\n
TRIAL NAME: PEP503-HN-1002<\/p>\n
PharmaEngine trial<\/p>\n
3rd dose level recruiting<\/p>\n
H2 2020- Last patient in for 5th (last) dose level<\/p>\n
Immuno-Oncology Program with NBTXR3<\/p>\n
Phase I Basket Trial for NBTXR3 combined with pembrolizumab or nivolumab in H&N, lung metastasis, liver metastasis patients <\/p>\n
TRIAL NAME: Study 1100<\/p>\n
Nanobiotix trial<\/p>\n
First patients treated<\/p>\n
Protocol extended to include patients with lung and liver metastases from any primary tumor. Recruitment ongoing<\/p>\n
Mid-year 2020 - first data reported<\/p>\n
Phase II Trial of reirradiation with NBTXR3 combined with anti-PD-1\/L1 for inoperable, locally advanced HN cancer <\/p>\n<\/p>\n
Phase II Trial for NBTXR3 combined with anti-PD-1 or anti-PD-L1 in Stage IV lung cancer<\/p>\n<\/p>\n
Phase I Trial for NBTXR3 combined with anti- CTLA4 and anti-PD-1 or PD-L1 in patients with advanced solid tumors and lung or liver mets<\/p>\n<\/p>\n
Phase II Trial for NBTXR3 for recurrent\/metastatic HNSCC patients with limited PD-L1 expression <\/p>\n<\/p>\n
MD Anderson trials<\/p>\n
Final stage of protocol development<\/p>\n<\/p>\n
Q2-Q3 2020 - Submission of protocols to FDA<\/p>\n
Development Across Other Indications<\/p>\n
Phase I Trial for NBTXR3 in hepatocellular carcinoma and liver metastasis patients<\/p>\n
TRIAL NAME: Study 103<\/p>\n
Nanobiotix trial<\/p>\n
Recruitment of the last patient at the 5th (last) dose level (one patient left to be treated)<\/p>\n
Q1 2020 - Update on results<\/p>\n
Phase I Trial for NBTXR3 in prostate cancer patients<\/p>\n
TRIAL NAME: Study 104<\/p>\n
Nanobiotix trial<\/p>\n
2nd dose level recruiting<\/p>\n
Q4 2020 - Update on results<\/p>\n
Phase I Trial for NBTXR3 in pancreatic cancer<\/p>\n<\/p>\n
Phase I Trial for NBTXR3 in lung cancer patients in need of reirradiation <\/p>\n<\/p>\n
Phase I Trial for NBTXR3 in esophageal cancer patients<\/p>\n<\/p>\n
MD Anderson trials<\/p>\n
Pancreas Regulatory process ongoing<\/p>\n<\/p>\n
Lung re-irradiation \/ Esophageal Submission of final protocol to regulatory process<\/p>\n
Q2 2020 - First patient treated in pancreas<\/p>\n<\/p>\n
Q3 2020 - Lung re-irradiation \/ Esophageal first patient treated<\/p>\n
Phase I\/II Trial for NBTXR3 combined with chemotherapy in rectal cancer patients<\/p>\n
TRIAL NAME: PEP503-RC-1001<\/p>\n
PharmaEngine trial<\/p>\n
4th (last) dose level recruiting<\/p>\n
H2 2020 - Report phase I results<\/p>\n
Next Steps in Soft Tissue Sarcoma<\/p>\n
Phase III Trial for NBTXR3 in soft tissue sarcoma of the extremities and trunk wall patients<\/p>\n
TRIAL NAME: Act.In.Sarc<\/p>\n
Nanobiotix trial<\/p>\n
Trial completed \/ data reported<\/p>\n
H2 2020- Further follow up of the patients<\/p>\n
Post-Approval Trial for NBTXR3 in soft tissue sarcoma of the extremities and trunk wall patients<\/p>\n
TRIAL NAME: TBD<\/p>\n
Nanobiotix trial<\/p>\n
Design established (100 patients)<\/p>\n
H2 2020 - Trial authorization by the relevant regulatory bodies expected<\/p>\n
Development in Head and Neck Moving Forward<\/p>\n
There are approximately 700,000 new head and neck cancer patients worldwide each year300,000 of these patients reside in the US and the European Union (EU) 1. Of these patients at diagnosis, 90% suffer from local disease and the remaining 10% have metastatic disease. 70-80% of all Head and Neck patients will receive radiation therapy, but significant unmet medical needs remain regarding either local control, systemic control, toxicity, or some combination of the three2. This is especially challenging for patients ineligible for platinum-based chemotherapy (cisplatin).<\/p>\n
Global Registration Trial for NBTXR3 in Head and Neck Patients Ineligible for Cisplatin<\/p>\n
As previously announced, Nanobiotix has begun interacting with the US Food and Drug Administration (FDA) on its regulatory pathway and met with the agency in October 2019 to refine the design elements of Study 312a phase III investigators choice, dual-arm, randomized (1:1) global registration trial including elderly head and neck cancer patients who are ineligible for platinum-based chemotherapy (cisplatin).<\/p>\n
More than half of head and neck cancers include large primary tumors which may invade underlying structures and\/or spread to regional nodes. Treatment of these locally advanced forms of the disease ordinarily requires aggressive, concerted measures. Due to potential comorbidities and toxicities associated with treatment, elderly and frail patients suffer from limited therapeutic options. Study 312 aims to target the unmet needs of this population.<\/p>\n
Patients in the control arm will receive radiation therapy with or without cetuximab (investigators choice), and patients in the treatment arm will receive NBTXR3 activated by radiation therapy with or without cetuximab (investigators choice). The trial will recruit around 500 patients, the initial readout will be based on event-driven progression-free survival (PFS), and the final readout will be based on PFS and overall survival (OS). The study will be powered to demonstrate the OS superiority of NBTXR3 activated by radiation therapy. In addition, quality of life (QoL) will be measured as a key secondary outcome.<\/p>\n
The Companys next step is to submit the final trial design to FDA and other global regulatory bodies within the month. A futility analysis is expected 18 months after the first patient is randomized, the interim analysis for PFS superiority is expected at 24-30 months, and final analysis will report on PFS and OS. In the event of favorable data from the initial readout, Nanobiotix plans to apply for conditional registration in the US.<\/p>\n
Confirming Efficacy with Phase I (Study 102) Expansion<\/p>\n
Nanobiotix has already reported promising early signs of efficacy for patients with head and neck cancer through Study 1023 a phase I trial of NBTXR3 nanoparticles activated by intensity-modulated radiation therapy (IMRT) in the treatment of advanced-stage head and neck squamous cell carcinoma (HNSCC). The patient population for Study 102 includes elderly and frail patients who are ineligible for cisplatin or intolerant to cetuximab.<\/p>\n
As a result of this report, the Company launched an expansion cohort with 44 additional patients to strengthen preliminary efficacy data. Recruitment for the expansion cohort has reached 38 of 44 patients and the initial readout is expected by mid-2020. Depending on the favorability of the final expansion phase data, the Company may seek to expedite the regulatory process in the EU.<\/p>\n
Additional Development in Head and Neck with Collaborators<\/p>\n
To serve as many head and neck cancer patients as possible and as mentioned above, the Company has engaged in ongoing clinical collaborations with MD Anderson in the US and PharmaEngine in Asia.<\/p>\n
The Company is collaborating with MD Anderson on nine (9) clinical trials across multiple indications, three (3) of which are expected to evaluate head and neck cancer in patient populations outside of the trials Nanobiotix is executing alone (e.g. borderline resectable, inoperable and neck cancer (re-irradiation), etc.)<\/p>\n
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Follow this link: After the achievement of major development milestones in 2019, 2020 offers great opportunity for Nanobiotix and NBTXR3 to fulfill unmet patient needs across oncology. Given NBTXR3s universal mode of action, our proof-of-concept in soft tissue sarcoma, and promising results from our phase I trial in head and neck cancers, we are confident that NBTXR3 activated by radiation therapy has the potential to significantly improve treatment outcomes for head and neck cancer patients. Beyond head and neck, we will continue to expand into additional indications and combination therapies. Continue reading
\nNANOBIOTIX Announces Plan for Global Phase III Head and Neck Cancer Registration Trial Along With Overall Development Update - BioSpace<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"