On February 28, 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 immune-oncology, reported favorable safety results from the histopathology evaluation of a preclinical study of the pharmacology of KB-GDT-01 (trademark: Deltacel) administered alone and in combination with a non-biological anti-tumor therapy in mice (Press release, Kiromic, FEB 28, 2023, View Source [SID1234627851]).
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The histopathology report, authored by a certified veterinary pathologist, revealed no adverse microscopic findings related to the administration of Deltacel alone or as part of the combination treatment.
"We’re pleased to receive a clean pharmacology profile with no adverse findings and are encouraged by the preclinical results to-date in support of our planned IND submission. This histopathology report includes results from more than 500 histological sections from multiple organs of mice treated with Deltacel, with the combination treatment of Deltacel and a non-biological anti-tumor therapy, or mice left untreated. This study completes the necessary dataset for authoring the Pharmacology Report of the Efficacy Study, which is an essential component of the nonclinical module of our IND application," stated Leonardo Mirandola, Ph.D., Chief Scientific Officer of Kiromic BioPharma.
"These findings are in line with what we observed in a study evaluating Deltacel monotherapy at a dose more than 7 times higher than the maximum dose planned for the Deltacel clinical trial, and they confirm that Deltacel was well tolerated in mice, even when given as part of a combination therapy that further boosted its potency," continued Dr. Mirandola. "Kiromic plans to submit the Deltacel IND application to the U.S. FDA in this first quarter, and if accepted, plans to begin the activation of the clinical trial process in the second quarter of 2023. The planned clinical study will evaluate Deltacel in combination with a non-biological anti-tumor therapy for the treatment of non-small cell lung cancer."