Favorable Safety Results are Last Component Needed to Complete the Nonclinical Module of the Company's IND Application
Does this $hitty stock action make sense? Hell no who can argue that? However this is when you load up and wait until PH1 because that was dang good news for an emerging bio startup with AI tech that treats LUNG CANCER tumors >> JMHO << but I've done a ton of DD on this just wait a storm is coming...
IND Submission and Activation of Clinical Trial Process on Track for the First Quarter and Second Quarter of this Year, Respectively
Kiromic BioPharma, Inc.
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."
Kiromic BioPharma, Inc. is a clinical-stage, fully integrated biotherapeutics company using its proprietary DIAMOND® artificial intelligence (AI) 2.0 target discovery engine to detect, develop, and commercialize cell therapies with a therapeutic focus on immuno-oncology. Kiromic is developing a multi-indication allogeneic cell therapy platform that exploits the natural potency of Gamma Delta T-cells to target solid cancers. Kiromic's DIAMOND® AI is where data science meets target identification to dramatically compress the years and hundreds of millions of dollars required to develop a live drug. The Company maintains offices in Houston, Texas. To learn more, visit www.kiromic.com and connect with us on Twitter and LinkedIn.
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