TVAX®’s second candidate (TVI-Kidney-1) is being evaluated for the treatment of kidney cancer and targets stage 4 renal cell carcinoma.
As with TVI-Brain-1, this drug candidate is supported by positive Phase 2 clinical data, as well as extensive preclinical and Phase 1 safety studies. Based on these supportive data, TVAX has been authorized by the United States Food and Drug Administration (FDA) to conduct pivotal Phase 3 trials for TVI-Kidney-1 to support the therapy’s potential FDA approval.
Several independent clinical studies have validated the potential of TVI-Kidney-1 in treating patients with stage IV renal cell carcinoma. Data from an independent Phase 2 trial in 39 newly diagnosed stage IV renal cell carcinoma patients demonstrated a significant number of clinical responses (n=9), each of which was associated with significantly prolonged survival. Additionally, the overall survival for the 39 enrolled patients was prolonged compared to a historical control group (n=81). Data from this and other independent studies led to FDA’s authorization for TVAX to initiate pivotal Phase 3 studies with TVI-Kidney-1.