NEW YORK – Kiromic Biopharma said on Tuesday it has submitted an investigational new drug application to the US Food and Drug Administration to begin a clinical trial for its CAR T-cell therapy targeting solid tumors that express the biomarker iso-mesothelin.
If cleared by the FDA, the planned Phase I study, called ALEXIS-ISO-1, is expected to begin dosing patients by the end of the third quarter of 2021. The trial will enroll up to 30 patients with solid tumors expressing iso-mesothelin. The FDA decision on the IND is expected within a month.
The company identifies its drug targets, such as iso-mesothelin, using the combination of its CancerDiff data-mining tool and Diamond AI immunogenic peptide identification system. These technologies allow the Houston-headquartered firm to identify targetable tumor peptides.
This IND submission comes one week after Kiromic submitted another IND for its CAR T-cell therapy targeting solid tumors that express PD-L1. The company also expects to begin that trial, called ALEXIS-PRO-1, in the third quarter of 2021.
"This IND filing confirms the solidity of our portfolio and highlights the results obtained by our bioinformatics department and the application of our AI platform," Gianluca Rotino, Kiromic's chief strategy and innovation officer, said in a statement. "In combination with the ALEXIS-PRO-1 clinical trial, it represents the second element of the development of our clinical strategy, which will allow us at the end of the dose escalation phase of this trial to select the best indication for the expansion phase that we project will ultimately lead to a biologics license application."