Nanobiotix has named senior pharmaceutical executive Alain Dostie its chief operating officer. Dostie will head development of NBTXR3 — a radio-enhancer nanoparticle to treat seven types of cancer including prostate cancer.
The company hopes NBTXR3 will win its first European approval in 2017, CEO Laurent Levy said in a news release.
“We are thrilled to welcome Alain to the Nanobiotix team as our company takes major strides to enter a new phase in its development,” Levy said. “His experience and values make Alain the perfect person to join the team to play this crucial role.”
Dostie, formerly oncology general manager at Novartis in Germany, said Nanobiotix is at the “tipping point” with the coming first Phase 2/3 interim readout and a potential first market approval this year.
NBTXR3 is a nano-sized compound, designed to be administered directly into the tumor site, bound and captured by cancer cells, and enhance radiotherapy energy within the tumor tissue.
A Phase 1/2 trial (NCT02805894) is currently being conducted in patients with intermediate and high-risk prostate cancer. The dose-escalation study will test NBTXR3 in two different modalities of radiation therapy; external beam radiation therapy (EBRT) delivered as intensity modulated radiotherapy, and the combination of EBRT and brachytherapy, a type of therapy in which radioactive seeds are implanted directly into the tumor.
The trial’s primary aims are to identify the maximum tolerated dose and dose-limiting toxicities of NBTXR3, and to determine the recommended dose for the Phase 2 part of the trial. In Phase 2, 20 subjects will receive NBTXR3 at the recommended dose in combination with EBRT, and 20 patients will receive it in combination with EBRT and brachytherapy.
In addition, Nanobiotix is now assessing NBTXR3 in a Phase 2/3 trial for soft tissue sarcoma (NCT02379845), a Phase 1/2 trial for hepatocellular carcinoma and liver metastasis (NCT02721056), two Phase 1/2 trials for head and neck cancer (NCT02901483 and NCT01946867), and a Phase 1/2 trial for rectal cancer patients (NCT02465593).