Kiromic BioPharma Reports Favorable Deltacel™ Preclinical Pharmacology Results

Rhea-AI Summary

Kiromic BioPharma (NASDAQ: KRBP) has announced favorable safety results from a preclinical study of its cell therapy Deltacel™. The histopathology evaluation revealed no adverse findings following the administration of Deltacel™, either alone or with a non-biological anti-tumor therapy in mice. This finding completes the necessary dataset for the pharmacology report needed for its IND application. The company plans to submit the IND to the U.S. FDA in Q1 2023 and expects to initiate clinical trials in Q2 2023, focusing on treating non-small cell lung cancer.

Positive

• Favorable safety results from preclinical study of Deltacel™, showing no adverse findings.
• Completion of the dataset for the pharmacology report is a critical step for the IND application.
• Plans to submit IND application to U.S. FDA in Q1 2023.
• Expected initiation of clinical trials in Q2 2023 for non-small cell lung cancer.

Negative

• None.

Favorable Safety Results are Last Component Needed to Complete the Nonclinical Module of the Company’s IND Application

IND Submission and Activation of Clinical Trial Process on Track for the First Quarter and Second Quarter of this Year, Respectively

HOUSTON--(BUSINESS WIRE)-- 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, announces 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.

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.”

About Kiromic BioPharma

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.

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Kiromic makes such forward-looking statements pursuant to the safe harbor provisions of the United States Private Securities Litigation Reform Act, Section 21E of the Securities Exchange Act of 1934, as amended, and other federal securities laws. All statements other than statements of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as: “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements regarding: Kiromic’s ability to achieve its objectives and Kiromic’s financing strategy and availability of funds. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in our Annual Report on Form 10-K for the year ended December 31, 2021, and as detailed from time to time in our other SEC filings. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance, or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, neither we nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements. Such forward-looking statements relate only to events as of the date of this press release. We undertake no obligation to update any forward-looking statements except to the extent required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230228005440/en/

Kiromic BioPharma

Linda Phelan Dyson, MPH

Global Head, Corporate Communications

ldyson@kiromic.com

281-468-7683

LHA Investor Relations

Tirth T. Patel

tpatel@lhai.com

212-201-6614

Source: Kiromic BioPharma, Inc.

FAQ

What are the recent developments for Kiromic BioPharma (KRBP) regarding Deltacel™?

Kiromic BioPharma announced favorable safety results from a preclinical study of Deltacel™, with plans to submit its IND application to the U.S. FDA in Q1 2023.

When will Kiromic BioPharma start clinical trials for Deltacel™?

Kiromic BioPharma plans to initiate clinical trials for Deltacel™ in Q2 2023.

What was the outcome of the preclinical study for Deltacel™ by Kiromic BioPharma?

The preclinical study revealed no adverse microscopic findings related to Deltacel™, indicating a favorable safety profile.

How many histological sections were evaluated in the Deltacel™ study?

More than 500 histological sections from multiple organs of treated mice were evaluated in the study.