Kiromic BioPharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has authorized the Company's Investigational New Drug (IND) application to initiate a Phase 1 clinical trial to evaluate Deltacel (KB-GDT-01) for patients with non-small cell lung cancer (NSCLC). Deltacel is the Company's allogeneic, non-engineered, off-the-shelf Gamma Delta T-cell (GDT) therapy. Notably, Deltacel does not require the use of any viral vector as many other cell therapies do, which, among other advantages, allows for reduced manufacturing costs.

Kiromic is seeking to address a significant unmet need by applying cell therapy to treat solid malignancies, which comprise 90% of all cancers, including NSCLC. Lung cancer is by far the leading cause of cancer death in the US, accounting for about 1 in 5 of all cancer deaths. Each year, more people die of lung cancer than of colon, breast, and prostate cancers combined.