Kiromic BioPharma, Inc. announced consistent safety, tolerability, and efficacy from follow-up visits of the first cohort of three patients enrolled in the Company's Deltacel-01 Phase 1 clinical trial. Deltacel-01 is evaluating Deltacel?? (KB-GDT-01), Kiromic's allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy, in patients with stage 4 Metastatic non-small cell lung cancer (NSCLC).

Kiromic expects to report preliminary safety, tolerability, and early efficacy results from this patient in May. Based on encouraging preliminary results from the first patient cohort, Kiromic intends to apply for Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) by the end of the second quarter. FTD offers several benefits and expedited review of drugs targeting a serious condition and fulfilling an unmet medical need, including NSCLC.

FTD also facilitates more frequent communication with the FDA, enabling sponsors to receive timely feedback and guidance throughout the drug-development process. Additionally, FTD may qualify Deltacel for Accelerated Approval and Priority Review, potentially reducing the time required to bring the drug to market.