NEW YORK – Kiromic on Monday said it has submitted an investigational new drug application to the US Food and Drug Administration for a Phase I trial exploring the activity of its allogeneic T-cell therapy, KB-PD1, in any PD-L1-expressing solid tumor.
The ALEXIS-PRO-1 trial will be a dose-escalation study of the PD-1, gamma-delta switch receptor therapy in 30 patients with PD-L1-positive, metastatic, progressive, or locally advanced solid tumors. The company has demonstrated promising efficacy and safety of the treatment in preclinical trials.
Unlike checkpoint inhibitors that block the interaction of PD-1 and PD-L1 receptors, "KB-PD1 rewires the brake into an accelerator," the company said in a statement. "In this way, Kiromic is optimistic that any cancer cell that expresses the PD-L1 marker will effectively activate and accelerate the ability of KB-PD1 to traffic through the tumor microenvironment, which thus far has proven to be an imposing barrier to effective T-cell treatments in solid cancers."
The FDA is slated to respond to Kiromic's IND in 30 days, after which the Houston-headquartered firm expects to dose the first patient in the Phase I study by Q3 2021. Kiromic projected the first data release in the study to be in Q4 and completion within 18 months.