Theraclion said yesterday its academic development partner, the University of Virginia, won an FDA nod to launch a study of the combined use of echotherapy high intensity focused ultrasound and immunotherapy drug pembrolizumab for treating patients with breast cancer.
The study will examine the combined treatment’s effect on fighting breast cancer tumor cells, the French company said. Theraclion is hopeful that HIFU treatment may locally potentiate immune responses induced by the immunotherapy drugs.
“Immunotherapy treatments help the body to fight against cancerous cells. This new treatment method is expected to have fewer side effects than existing cancer treatment alternatives. Nevertheless, large, solid masses are difficult for the immune system to access,” Dr. Patrick Dillon of the University of Virginia said in a prepared statement
“The HIFU treatment could be used to pre-treat a tumor in order to shrink the overall volume and, perhaps more importantly, allow the patient’s own immune system to access and recognize the malignant cells,” UVA breast care program co-director Dr. David Brenin said in prepared remarks.
In the trial, researchers will use Theraclion’s Echopulse HIFU system, which it said is currently being evaluated in a feasibility study in the US for non-invasive treatment of breast fibroadenomas.
“To our knowledge, this will be the first study combining HIFU and immunotherapy drugs in the field of breast cancer. Our system is specifically adapted for this combination treatment, as it is the only robotic system with flexible access to the target. We are eager to see this kind of investigation, as we have always committed to our customers and shareholders that we will leverage our outstanding clinical results in benign tumors into progress treating malignant disease. This is a critical milestone for today’s breast users, gynecologists, oncologists and radiologists, who are excited to explore this new path in the fight against cancer,” Theraclion CEO David Caumartin said in a press release.