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

Rhea-AI Summary

Kiromic Biopharma, Inc. (Nasdaq: KRBP) has submitted a novel Investigational New Drug (IND) application to the FDA for a Phase 1 clinical trial of KB-ISM, a universal CAR-T therapy targeting solid tumors expressing Iso-mesothelin. The trial, titled ALEXIS-ISO-1, will evaluate the safety and efficacy of allogeneic Gamma Delta T-cells expressing a CAR against Isoform 2 of Mesothelin. The trial is set to enroll 30 patients and will last 18 months, with initial data expected by Q4 2021. FDA feedback on the IND submission is anticipated within 30 days.

Positive

• Submission of IND for a novel CAR-T therapy could position KRBP favorably in the oncology market.
• The trial targets a significant patient population with solid tumors expressing Iso-mesothelin.
• Expectations of FDA feedback within 30 days could expedite trial initiation.

Negative

• Potential delays in FDA approval may impact timelines for trial commencement.
• Market competition in CAR-T therapies may limit KRBP's market share.

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

FAQ

What is the purpose of the IND submission by Kiromic Biopharma (KRBP)?

The IND submission aims to initiate a Phase 1 clinical trial for KB-ISM, a universal CAR-T therapy targeting solid tumors expressing Iso-mesothelin.

When is the FDA expected to respond to KRBP's IND submission?

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

What is the duration of the clinical trial for KB-ISM?

The clinical trial for KB-ISM is expected to last 18 months.

How many patients will be involved in the KB-ISM clinical trial?

The clinical trial will enroll 30 patients.

What type of therapy is KB-ISM?

KB-ISM is an allogeneic CAR-T live cell therapy targeting Isoform 2 of Mesothelin.