Kiromic Announces FDA IND Submission First-In-Human, AI derived Off-The-Shelf IsoMesothelin Gamma Delta CAR T-cell Therapy, 30 Days Before the End of the Second Quarter - Seite 3

Kiromic is optimistic that any cancer cell that expresses the Isoform 2 Mesothelin marker will effectively activate and accelerate the ability of KB-ISM to traffic through the tumor microenvironment (TME), which thus far has proven to be an imposing barrier to effective T cell treatments in solid cancers.

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CEO of Kiromic, Dr. Maurizio Chiriva-Internati, DBSc, PhDs stated:

“Kiromic’s Off-The-Shelf (OTS) CAR Gamma Delta T-Cell (GDT) is a unique product, and I am very excited to present this IND to the FDA.

This technology is meant to potentially change the Cell and Gene Therapy landscape, helping to address the major issues on manufacturing, safety, cost and most importantly, time.

A Bioinformatics approach in the Cell Therapy & Gene Therapy field is disruptive and will help to screen and design specific binder (monoclonal Antibodies) with more specificity and avidity creating better and more robust therapy with less side effects.

Kiromic is in a unique position because its bioinformatic engine combines CancerDiff, a data-mining tool for the identification of tumor-preferred isoforms, with Diamond, an AI-driven immunogenic peptide identification system.

This combination allows Kiromic to identify targetable sections of a tumor isoform (peptides) that are a unique signature of cancer cells.

The advantage of Kiromic’s system is two-fold: 1) it saves time and money because it allows the prioritization of tumor-selective targets, and 2) it maximizes the likelihood of identifying targets that are safe by increasing the targeting specificity.

I am proud of our Translational and CMC teams that were capable of creating a feeder free expansion system with a purity of over 99% GDT, and it is very exciting that we can cryopreserve these cells in long term storage so that they are available on demand for shipment and ready to inject around the world.

I believe that our science will reshape and revolutionize the approach to Immune Oncology treatment in the years to come.”

CFO of Kiromic, Mr. Tony Tontat stated:

"With this IsoMesothelin IND filing, Kiromic shows its commitment to invest in the latest AI technologies and then bring these AI predicted biomarkers into the clinic.

Going forth, we will look to announce our further investments in AI and how these investments in AI will keep the company in front of competitors in our space who are working without AI."

CSIO of Kiromic, Mr. Gianluca Rotino stated: