PARIS & HOUSTON—Last month, Nanobiotix and the University of Texas MD Anderson Cancer Center announced a large-scale comprehensive clinical collaboration focusing on new strategies in treating patients with a number of cancer types.
This collaboration will expand clinical development of NBTXR3, a first-in-class product that is activated by radiotherapy. This follows an immunotherapeutic preclinical research collaboration, launched in April 2018, to explore the potential of NBTXR3 in immuno-oncology with checkpoint inhibitors and its potential to control metastatic disease in patients with lung cancer.
NBTXR3 works by activating the immune system for both local control and systemic disease treatment, and is designed to destroy tumors through physical cell death and metastasis due to immunogenic cell death leading to activation of the immune system. It reportedly boasts a high degree of biocompatibility and only requires a single dose before any radiation therapy begins. Nanobiotix believes its product shows the potential for clinical benefit in an advanced Phase 3 randomized clinical trial. NBTXR3 is currently being evaluated in head and neck cancer with locally advanced squamous cell carcinoma of the oral cavity or oropharynx in elderly and frail patients unable to receive chemotherapy.
The other ongoing studies are treating patients with liver cancers (hepatocellular carcinoma and liver metastasis), locally advanced or unresectable rectal cancer in combination with chemotherapy, head and neck cancer in combination with concurrent chemotherapy, and prostate adenocarcinoma. The trials initiated as a part of this collaboration will aim to evaluate innovative strategies for treating patients with head and neck, pancreatic, thoracic, lung, gastrointestinal and genitourinary cancers.
The first step is a series of nine new Phase 1/2 clinical trials conducted by MD Anderson. These trials will involve approximately 340 patients and will focus on the use of NBTXR3 either alone or in conjunction with checkpoint inhibitors. They will look at various disease stages—including low-risk/good prognostic patients, locally advanced disease and metastatic disease across different radiation modalities—as well as compare different levels of intensity of radiation to evaluate whether the addition of NBTXR3 to radiotherapy will improve progression-free survival, loco-regional control, quality of life and organ preservation.
Dr. Thomas Morris, global head of development for Nanobiotix, said, “It is important for Nanobiotix to collaborate with academic institutions to develop a broad spectrum of clinical trials in an expedited fashion. 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 benefiting patients by applying novel research and bringing forward an innovative therapy. 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.”
Funding for this collaboration will come in phases, but represents a total of $12 million in investment.
Currently, Nanobiotix is also running an immuno-oncology development program. In the United States, the company received the FDA’s approval to launch a clinical study of NBTXR3 activated by radiotherapy in combination with anti-PD1 antibodies in patients with head and neck squamous cell carcinoma or non-small cell lung cancer. Incorporated in 2003, Nanobiotix is a leading, late clinical-stage nanomedicine company “pioneering new approaches to significantly change patient outcomes by bringing nanophysics to the heart of the cell.”
The Houston-based University of Texas MD Anderson Cancer Center ranks as one of the world’s most respected centers focused on cancer patient care, research, education and prevention, and it is one of only 49 comprehensive cancer centers designated by the National Cancer Institute (NCI).