On May 1, 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 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) (Press release, Kiromic, MAY 1, 2023, View Source [SID1234630779]).

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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.

"Receiving the authorization from the FDA to administer Deltacel to patients enables us to advance our GDT therapy candidate into the clinic. As a potentially well tolerated and effective treatment, we look forward to the opportunity for Deltacel to have a meaningful impact on the hundreds of thousands of patients with non-small cell lung cancer and with other solid cancers," stated Pietro Bersani, Chief Executive Officer of Kiromic BioPharma. "We are in the process of activating clinical trial sites, and we look forward to providing updates on our progress."