On June 7, 2022 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, reported 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 (Press release, Kiromic, JUN 7, 2022, View Source [SID1234615692]).

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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:

Deltacel in combination with a standard antitumor modality
Procel in combination with a standard antitumor modality
Isocel in combination with a standard antitumor modality
Procel as monotherapy
Isocel as monotherapy