ADXS-HER2 has received orphan drug designation from the FDA and EMA for the treatment of osteosarcoma. In April 2016 ADXS-HER2 was granted Fast Track Designation by the FDA for treatment of patients with newly diagnosed, non-metastatic, surgically-resectable osteosarcoma.
ADXS-HER2 is being evaluated in a first-in-human Phase 1b dose-escalation clinical study for the treatment of patients with metastatic HER2-expressing solid tumors. The dose escalation portion of the study will investigate the safety and tolerability of ADXS-HER2 as a monotherapy in patients diagnosed with metastatic HER2-expressing solid tumors. Results from the study will be used to determine the future clinical development program of ADXS-HER2.
Advaxis plans to conduct a pivotal trial in pediatric osteosarcoma in collaboration with Children’s Oncology Group (COG).