On April 3, 2023 Kiromic BioPharma, Inc. (NASDAQ: KRBP) ("Kiromic" or the "Company"), a clinical-stage fully-integrated biotherapeutics company using its proprietary DIAMOND artificial intelligence and data mining platform to develop cell therapies with a focus on immuno-oncology, reported the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a Phase 1 clinical trial to evaluate KB-GDT-01, or Deltacel, in combination with an anti-tumor therapy for the treatment of non-small cell lung cancer (NSCLC) (Press release, Kiromic, APR 3, 2023, View Source [SID1234629751]).

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Deltacel is the Company’s allogeneic, non-viral, non-engineered off-the-shelf Gamma Delta T-cell (GDT) therapy. The Company is seeking to address the significant unmet need of applying cell therapy to treat solid malignancies, which comprise 90% of all cancers, including NSCLC.

"Submitting this IND brings us one step closer to beginning human clinical testing with this incredible science and providing a promising treatment option to the tens of thousands of patients living with non-small cell lung cancer. While this is the second most common type of cancer, lung cancer is the leading cause of cancer deaths in the United States, accounting for about 1 in 5 of all cancer deaths," stated Pietro Bersani, Chief Executive Officer of Kiromic BioPharma. "This milestone, achieved on March 31, 2023, is a tremendous accomplishment by our team, and we look forward to initiating clinical testing upon IND acceptance by the FDA."