4 Apr 2017
NANOBIOTIX (Euronext: NANO – ISIN: FR0011341205), a late clinical-stage nanomedicine company pioneering new approaches to the treatment of cancer, today announced the expansion and acceleration of its clinical development activities. These include:
Acceleration of the head and neck cancer program. Phase I/II data will be presented at ASCO in June
Expansion of Nanobiotix’s Immuno-Oncology program into patients focused on the objective of turning cold tumors into hot tumors. Nanobiotix will present the first clinical data from this program mid year
NBTXR3: New programs and upcoming data
Presentation of the Phase I/II data of Nanobiotix’s European head and neck trial with NBTXR3 at the American Society of Clinical Oncology (ASCO) Annual Meeting in June. Nanobiotix is preparing the next clinical trials of the head and neck cancer program. Based on the value of the data to be presented in June, the Company will determine the fastest pathway to the U.S. and European markets.
Presentation of the first clinical data from Nanobiotix’s new clinical program in Immuno-Oncology mid year. Based on the preclinical proof of concept presented in November 2016 at the Society for Immunotherapy of Cancer (SITC), Nanobiotix initiated an exploratory clinical biomarkers study in soft tissue sarcoma patients (data from Nanobiotix’s phase II/III trial in soft tissues sarcoma). This trial investigates whether NBTXR3 could play a role in Immuno-Oncology by turning cold tumors into hot tumors (compared with radiotherapy alone).
Ongoing activities
Continuation of the Phase II/III trial in soft tissue sarcoma with NBTXR3, recommended by an Independent Data Monitoring Committee (IDMC), which evaluated the safety and efficacy data of two thirds of the patients in the “Act.in.Sarc” study. As planned and communicated, the completion of the patient recruitment process for this trial is expected by the end of Q2 2017, with data, except for long-term follow-up, expected by the end of 2017.
Nanobiotix will continue to develop NBTXR3 in other indications: These include prostate cancer (Phase I/II), liver cancers (Hepatocellular Phase I/II and liver cancer metastases Phase I/II), rectum cancer (Phase I/II – by PharmaEngine) and head and neck cancers in patients receiving chemotherapy (Phase I/II – by PharmaEngine). In H2 2017, the prostate cancer indication should deliver preliminary safety and feasibility data. Additionally, before the end of 2017, Nanobiotix aims to complete patient recruitment for the Phase I part in liver cancers, and may proceed to select the patient population for the dose-expansion part of the trial (Phase II).
In parallel, Nanobiotix is accelerating its market preparations for NBTXR3’s launch on the European market. The first approval (CE marking) in Europe is expected in H2 2017.