Kiromic BioPharma Significantly Expands Gamma Delta T cell Product Pipeline with New Sponsored Research Agreement

Rhea-AI Summary

Kiromic BioPharma, Inc. (NASDAQ: KRBP) announced a two-year sponsored research agreement with Dr. James W. Welsh from The University of Texas MD Anderson Cancer Center. This agreement aims to generate in vivo preclinical data for Kiromic’s Gamma Delta T cell therapies, enabling three new investigational drug (IND) applications to the FDA. The first IND submission, Deltacel™, is expected in the second half of this year, with the initiation of its clinical trial anticipated by year’s end. This addition will expand Kiromic's therapy pipeline to five allogeneic GDT clinical trials.

Positive

• Entering a two-year sponsored research agreement to generate in vivo preclinical data.
• Three new IND applications expected to enhance the therapeutic pipeline to five.
• First IND submission (Deltacel™) anticipated in the second half of the year.

Negative

• None.

In Vivo Preclinical Data Expected to Enable Three New IND Applications to Evaluate Company’s Gamma Delta T cell Product Candidates Procel™, Isocel™, and Deltacel™

HOUSTON--(BUSINESS WIRE)-- Kiromic BioPharma, Inc. (NASDAQ: KRBP), a clinical-stage biotherapeutics company using its proprietary DIAMOND^® artificial intelligence (AI) and data mining platform to discover and develop cell and gene therapies with a focus on immuno-oncology, today announces it has entered into a sponsored research agreement (SRA) with Principal Investigator James W. Welsh, M.D. of The University of Texas MD Anderson Cancer Center.

Under the two-year SRA, in vivo preclinical data will be generated from Kiromic’s Gamma Delta T cell (GDT) allogeneic therapies. This SRA is intended to evaluate efficacy and patient safety outcomes to support three new investigational drug (IND) applications to the U.S. Food and Drug Administration (FDA).

“We believe that the SRA will enable us to generate key in vivo data efficiently and swiftly that will demonstrate the synergistic advantages of our Gamma Delta T cell therapies in combination with existing anticancer treatment modalities. These submissions will expand the total number of our product candidate therapies to five. The first of these three new IND submissions - the Deltacel™ - is expected to be submitted during the second half of the year,” stated Pietro Bersani, Chief Executive Officer of Kiromic BioPharma. “Importantly, we expect to begin the activation of the Deltacel clinical trial by the end of this year. We believe utilizing non-genetically engineered Gamma Delta T cells as our first-in-human study is ideal to establish the tolerability and safety of our proprietary allogeneic cell therapy platform.”

In addition to Deltacel/KB-GDT - Kiromic’s non-engineered Gamma Delta T cells that are expanded, enriched and activated through a proprietary method - the second IND is expected to focus on Procel/KB-PD1, a genetically engineered product candidate targeting PD-L1+ tumors. The third IND is expected to focus on Isocel/KB-ISO, a genetically engineered product candidate targeting mesothelin isoform 2+ tumors. This isoform of mesothelin is a tumor-specific target identified by Kiromic’s proprietary DIAMOND AI bioinformatics platform.

The SRA and the anticipated filing of the three IND applications described above will expand Kiromic’s therapeutic pipeline to five allogeneic GDT clinical trials as follows:

1. Deltacel in combination with a standard antitumor modality
2. Procel in combination with a standard antitumor modality
3. Isocel in combination with a standard antitumor modality
4. Procel as monotherapy
5. Isocel as monotherapy

About Kiromic BioPharma

Kiromic BioPharma is a clinical-stage biotherapeutics company using its proprietary DIAMOND^® artificial intelligence (AI) platform to discover and develop cell and gene therapies with a therapeutic focus on immuno-oncology and other diseases. Kiromic is in the process of developing a multi-indication gamma delta allogeneic T cell therapy treatment platform that exploits the natural potency of gamma delta T cells to target solid cancers. Kiromic is focused on discovering, developing and commercializing novel immuno-oncology therapies through its robust product pipeline, leveraged by DIAMOND^® AI, a proprietary target discovery engine where data science meets target identification to dramatically compress the timeline and cost of drug development. 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 current and anticipated IND applications including statements regarding the scope of an IND application; the Deltacel™ product platform; the sponsored research agreement and the data that will be generated as a result of such collaboration; the timing for submitting and activating Kiromic’s IND applications; the benefits of utilizing non-genetically engineered Gamma Delta T cells as our first in-human study; Kiromic’s ability to achieve its objectives; and the timing for the initiation and successful completion of Kiromic’s clinical trials of its product candidates. 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 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/20220607005593/en/

Kiromic BioPharma

Linda Phelan Dyson, MPH, Global Head, Corporate Communications

281-468-7683

ldyson@kiromic.com

LHA Investor Relations

Tirth T. Patel

212-201-6614

tpatel@lhai.com

Source: Kiromic BioPharma, Inc.

FAQ

What is the purpose of the sponsored research agreement announced by Kiromic BioPharma?

The agreement aims to generate in vivo preclinical data for Gamma Delta T cell therapies to support three new IND applications.

When will Kiromic's first IND submission, Deltacel™, be filed?

The Deltacel™ IND submission is expected to be submitted in the second half of this year.

How will the new IND applications impact Kiromic BioPharma's clinical pipeline?

The new IND applications will expand Kiromic's therapeutic pipeline to a total of five allogeneic GDT clinical trials.

Who is the principal investigator for the sponsored research agreement with Kiromic BioPharma?

Dr. James W. Welsh from The University of Texas MD Anderson Cancer Center is the principal investigator.

What is Kiromic BioPharma's focus in developing its therapies?

Kiromic BioPharma focuses on immuno-oncology and developing cell and gene therapies using its DIAMOND® AI platform.