StemCell Therapy

Regulatory News:

"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

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.

Global Development Plan Visualization

TRIAL

STATUS

ANTICIPATED NEXT STEPS

Development in Head and Neck Moving Forward

Phase III Registration Trial for NBTXR3 in head and neck patients ineligible for cisplatin

TRIAL NAME: STUDY 312

Nanobiotix trial

Design completed based on last interactions with FDA and European payers (EUnetHTA)

Jan 2020 - Submission of final protocol to FDA and other global regulatory bodies

Phase I and Phase I Expansion Trial for NBTXR3 in head and neck patients ineligible for cisplatin or intolerant to cetuximab

TRIAL NAME: Study 102/ 102 Expansion

Nanobiotix trial

Phase I dose escalation completed / data reported 19 patients

Dose Expansion 38 of 44 patients recruited

Q1 2020 - Update of dose escalation patients follow-up

Mid 2020 - First expansion phase data on efficacy and safety of dose expansion

Phase I/II Trial for NBTXR3 combined with cisplatin for head and neck patients

TRIAL NAME: PEP503-HN-1002

PharmaEngine trial

3rd dose level recruiting

H2 2020- Last patient in for 5th (last) dose level

Immuno-Oncology Program with NBTXR3

Phase I Basket Trial for NBTXR3 combined with pembrolizumab or nivolumab in H&N, lung metastasis, liver metastasis patients

TRIAL NAME: Study 1100

Nanobiotix trial

First patients treated

Protocol extended to include patients with lung and liver metastases from any primary tumor. Recruitment ongoing

Mid-year 2020 - first data reported

Phase II Trial of reirradiation with NBTXR3 combined with anti-PD-1/L1 for inoperable, locally advanced HN cancer

Phase II Trial for NBTXR3 combined with anti-PD-1 or anti-PD-L1 in Stage IV lung cancer

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

Phase II Trial for NBTXR3 for recurrent/metastatic HNSCC patients with limited PD-L1 expression

MD Anderson trials

Final stage of protocol development

Q2-Q3 2020 - Submission of protocols to FDA

Development Across Other Indications

Phase I Trial for NBTXR3 in hepatocellular carcinoma and liver metastasis patients

TRIAL NAME: Study 103

Nanobiotix trial

Recruitment of the last patient at the 5th (last) dose level (one patient left to be treated)

Q1 2020 - Update on results

Phase I Trial for NBTXR3 in prostate cancer patients

TRIAL NAME: Study 104

Nanobiotix trial

2nd dose level recruiting

Q4 2020 - Update on results

Phase I Trial for NBTXR3 in pancreatic cancer

Phase I Trial for NBTXR3 in lung cancer patients in need of reirradiation

Phase I Trial for NBTXR3 in esophageal cancer patients

MD Anderson trials

Pancreas Regulatory process ongoing

Lung re-irradiation / Esophageal Submission of final protocol to regulatory process

Q2 2020 - First patient treated in pancreas

Q3 2020 - Lung re-irradiation / Esophageal first patient treated

Phase I/II Trial for NBTXR3 combined with chemotherapy in rectal cancer patients

TRIAL NAME: PEP503-RC-1001

PharmaEngine trial

4th (last) dose level recruiting

H2 2020 - Report phase I results

Next Steps in Soft Tissue Sarcoma

Phase III Trial for NBTXR3 in soft tissue sarcoma of the extremities and trunk wall patients

TRIAL NAME: Act.In.Sarc

Nanobiotix trial

Trial completed / data reported

H2 2020- Further follow up of the patients

Post-Approval Trial for NBTXR3 in soft tissue sarcoma of the extremities and trunk wall patients

TRIAL NAME: TBD

Nanobiotix trial

Design established (100 patients)

H2 2020 - Trial authorization by the relevant regulatory bodies expected

Development in Head and Neck Moving Forward

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).

Global Registration Trial for NBTXR3 in Head and Neck Patients Ineligible for Cisplatin

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).

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.

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.

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.

Story continues

Confirming Efficacy with Phase I (Study 102) Expansion

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.

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.

Additional Development in Head and Neck with Collaborators

See more here:
NANOBIOTIX Announces Plan for Global Phase III Head and Neck Cancer Registration Trial Along With Overall Development Update - Yahoo Finance

This entry was posted on January 8, 2020 at 11:44 pm and is filed under Nano medicine. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |