A variety of malignant brain and central nervous system tumors kill about 15,000 people in the United States each year, often after difficult courses of surgery, radiation and chemotherapy. Patients with Grade 4 glioblastomas — the most aggressive type — survive under 15 months after diagnosis. Radiotherapy plus Temozolomide plus radiotherapy was FDA approved for Glioblastoma with survival benefit of only 2.5 months, median survival 14.6 months versus 12.1 months radiotherapy alone.
Aurora’s AU105 was tested in a Phase I/II clinical trial of 16 Newly Diagnosed Glioblastoma patients, and showed it was safe with no signs of severe adverse events. CAR T Cells can transverse through the Blood-Brain Barrier, one partial response had nearly 50% reduction of the brain tumor. The median Overall survival for patients treated with AU105 Car T Cells was 24.8 months nearly double the median overall survival that of matched historical controls.
Aurora is planning to apply for Breakthrough Therapy Designation. The Company is planning a Ground-Breaking Randomized High-Powered Phase IIB/III clinical trial in Newly Diagnosed Glioblastoma with AU105.
Aurora is currently recruiting for a Phase I/II Trial in Recurrent Glioblastoma using novel intracranial catheter, to bypass the Blood Brain Barrier and deliver CAR T “serial killer” cells locally.