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

Kiromic Biopharma, Inc. (Nasdaq: KRBP), an immuno-oncology target discovery and gene-editing company with a proprietary artificial intelligence neural network platform (Diamond AI) that is used to develop novel oncology therapeutics, today announced the submission of a novel Investigational New Drug (IND) to the U.S. Food and Drug Administration (FDA) for a Phase 1 clinical trial that has the potential to be a universal CAR T-Cell therapy for any solid malignancy that expresses the biomarker Iso-mesothelin, with higher efficacy, higher safety, as well as lower manufacturing and distribution costs.

The title of the clinical trial is: ALEXIS-ISO-1: A Phase 1, Open-label, Dose Escalation Study of KB-ISM, Allogeneic Gamma Delta T-cells Expressing a Chimeric Antigenic Receptor (CAR) Against the Isoform 2 of Mesothelin in Subjects with Metastatic or Progressive Locally Advanced Solid Malignancies.

The FDA feedback is expected within 30 days from IND submission.

Key features of the IND:

Product Name	KB-ISM
Product Type	CAR-T live cell therapy
Cancer Type	All solid tumors that express IsoMesothelin
Targeting	Isoform 2 of Mesothelin (AI algorithm predicted targets)
Patient Type	Patients with solid tumor positive for ISM
No. of Patients	30
Dosing	Dose escalation
Duration of Trial	18 months
First-in-human	3Q 2021 pending FDA authorization
First data from Trial	4Q 2021

How Our KB-ISM Live Cell Therapy CAR-T Improves CAR-T Market:

	Marketed and traditional CAR-T	Kiromic KB-ISM
Malignancies (Cancer Type)	Hematologic	Solid Tumors
Live Cell Origin	Autologous