Kiromic BioPharma announces the submission of an Investigational New Drug application to the U.S. Food and Drug Administration 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. Deltacel is the Company’s allogeneic, non-viral, non-engineered off-the-shelf Gamma Delta T-cell herapy. 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."
Published first on TheFly
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