Nanobiotix has named veteran pharmaceutical executive Alain Dostie as its chief operating officer. Among other functions, Dostie will lead the development, manufacturing, market access and sales of the French company’s lead product, NBTXR3 — a nano-sized compound designed to enhance radiotherapy efficacy without increasing toxicity in the surrounding tissues.
NBTXR3 is being evaluated in soft tissue sarcoma (STS), head and neck cancers, prostate cancer and liver cancers (primary and metastases). Additionally, head and neck cancer as wella s rectal cancer trials led by Nanobiotix’s Taiwanese partner, PharmaEngine, are underway in the Asia-Pacific region. The company may receive its first European approval in 2017.
“Nanobiotix is at the tipping point of its value creation with the coming first Phase 2/3 interim readout and a potential first market approval this year,” Dostie, former oncology general manager at Novartis Germany, said in a news release.
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. Recently, Nanobiotix revealed promising preliminary data for NBTXR3 in patients with liver cancer, either primary or metastatic tumors.
Patients with primary liver cancer, or hepatocellular carcinoma, and liver metastasis have very few or no therapeutic options available. Radiation therapy has been shown to improve patients’ outcomes in a dose-dependent manner, but delivering high-dose radiation is complex and often problematic due to toxicity.
Nanobiotix is conducting a Phase 1/2 study (NCT02721056) evaluating the safety and efficacy of NBTXR3 nanoparticles administrated by intra-tumoral or intra-arterial injection and activated by high-precision radiation therapy — delivered as high dose fractions — for the treatment of liver cancers.
The study was designed to enroll up to 200 patients with either primary liver cancer or liver metastasis. Each will receive four increasing doses of NBTXR3, injected 24 hours before activation with stereotactic body radiation therapy (SBRT).
To date, two sub-groups of patients received the 10 percent dose of NBTXR3 with intra-tumoral injections — or a volume of NBTXR3 injection equivalent to 10 percent of the baseline tumor volume.
Results revealed that the compound stays within the tumors, with no leakage in the surrounding healthy tissues until the end of the radiotherapy treatment. Nanobiotix is now recruiting participants to the next dose levels, in order to examine the safety and feasibility of higher doses of NBTXR3, assessed through progression-free survival, complete response rate, and overall survival.
In addition, Nanobiotix is assessing NBTXR3 in a Phase 2/3 trial for soft tissue sarcoma (NCT02379845), a Phase 1/2 trial for prostate cancer (NCT02805894), two Phase 1/2 trials for head and neck cancer (NCT02901483 and NCT01946867), and a Phase 1/2 trial for rectal cancer patients (NCT02465593).