NEW YORK – Anocca said Tuesday that it is seeking permission from the European Medicines Agency to begin testing its T-cell receptor (TCR) T-cell therapy ANOC-001 in a Phase I/II trial in advanced KRAS G12C-mutated pancreatic cancer.
The Sodertalje, Sweden-based firm has submitted a clinical trial application to the EMA. If approved, the firm will begin the VIDAR-1 trial during the second quarter of 2025.
Anocca has designed VIDAR-1 as an umbrella trial, which will allow it to evaluate multiple TCR T-cell therapy candidates targeting various KRAS driver mutations. Each arm of the trial will include 20 patients with a specific KRAS mutation and HLA type. The firm is planning to conduct the Phase I portion of the trial at eight sites in four countries and add additional countries and sites during the Phase II portion of the trial.
"With our in-house [current good manufacturing practice] facilities and gene-edited autologous TCR-T manufacturing capability, we can efficiently and cost-effectively develop new investigational products at scale," Anocca CEO and Cofounder Reagan Jarvis said in a statement. "Our ambition is to grow our pipeline rapidly across the immense untapped target space for TCR T-cell therapies in solid tumors."