Nanobiotix is planning to conduct nine Phase 1/2 clinical trials in collaboration with the University of Texas MD Anderson Cancer Center to study the company’s investigational compound NBTXR3.
The trials, which will include about 340 patients total, will examine NBTXR3 in six cancer types, including head and neck, pancreatic, thoracic, lung, gastrointestinal, and genitourinary cancers. Most are expected to launch this year.
“It is important for Nanobiotix to collaborate with academic institutions to develop a broad spectrum of clinical trials in an expedited fashion,” Thomas Morris, global head of development at Nanobiotix, said in a press release. “This is a tremendous opportunity to strengthen our scientific and clinical understanding of the potential of NBTXR3 across the wide range of cancers treated with radiotherapy, with the goal of benefitting patients by applying novel research and bringing forward an innovative therapy.”
NBTXR3 is a nano-sized therapy developed to be injected directly into a tumor before radiation therapy is given, with the goal of enhancing the effectiveness of radiotherapy. The particles, designed to penetrate cancer cells and remain within the tumor, absorb radiation energy delivered by radiotherapy and magnify its effect locally.
This is expected to induce the death of cancer cells and to activate the immune system both locally and throughout the body.
In a Phase 2/3 trial in soft tissue sarcoma, NBTXR3 treatment helped 16.1% of patients achieve a complete response to radiation therapy, an effect that was only seen in 7.9% of patients receiving radiation alone.
The new clinical collaboration is intended to further develop NBTXR3 and test its efficacy when activated by radiotherapy, given either as a stand-alone agent or in combination with immune checkpoint inhibitors.
NBTXR3 will be tested with different radiation modalities — one-time radiation and re-irradiation, and using different levels of radiation intensity — to determine if the treatment improves quality of life and organ preservation, and extends the time patients live without their disease progressing.
In addition, researchers will test NBTXR3 in patients at different disease stages, including those at low risk and with a good prognosis, patients with a locally restricted tumor, and those whose cancer has already spread to distant organs.
“The collaboration between Nanobiotix and MD Anderson expands the number of NBTXR3 clinical trials to 16, illustrating our dedication to identify more effective treatments for cancer patients,” Morris said.
NBTXR3 is already undergoing testing in several Phase 1/2 trials for the treatment of head and neck cancer (NCT01946867, NCT02901483), liver cancer (NCT02721056), rectal cancer (NCT02465593), and prostate cancer (NCT02805894).
An additional Phase 1/2 trial (NCT03589339) will also test the treatment in combination with a PD-1 inhibitor — Opdivo (nivolumab) or Keytruda (pembrolizumab) — in patients with advanced head and neck squamous cell carcinoma or metastatic non-small cell lung cancer.
