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 CA
|
