ALEXIS-Pro-1

ALEXIS-Pro-1 is an allogeneic, off-the-shelf chimeric antigen receptor (CAR) Gamma Delta T-cell (GDT) therapy developed by Kiromic BioPharma. It was designed to target Mesothelin (MSLN), a cell surface glycoprotein frequently overexpressed in various solid tumors, including mesothelioma, non-small cell lung cancer (NSCLC), and ovarian cancer. The candidate was part of Kiromic's ALEXIS (Allogeneic Expansible Immunotherapy Solution) platform, which utilized the company's proprietary Diamond AI for target discovery and selection. In May 2021, Kiromic submitted an Investigational New Drug (IND) application for ALEXIS-Pro-1, but the FDA placed the application on clinical hold in June 2021 due to concerns regarding chemistry, manufacturing, and controls (CMC). The company subsequently faced regulatory scrutiny and an SEC settlement related to the non-disclosure of this clinical hold during a fundraising round. Following internal restructuring and a strategic pivot toward its lead candidate, Deltacel (KB-GDT-01), Kiromic has effectively discontinued the development of the ALEXIS-Pro-1 program.