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 2

 

Live Cells from pre-treatment patients

Allogenic

 

Live Cells from healthy donors

Live Cell Cloning
(Manufacturing)

Single batch
Single dose

Single batch
Multi dose

 

(aka. Off-The-Shelf)

Mass Manufacturing

on-demand
a single patient

-- Will be manufactured like a traditional drug

-- Kiromic proprietary manufacturing

-- Kiromic proprietary cryopreservation processing techniques

This submission follows by one week the company’s prior submission of the IND for a phase 1 trial of the Gamma Delta chimeric PD1 Switch Receptor.

Both clinical trials support Kiromic’s clinical strategy of developing a “universal” off-the-shelf cell therapy against solid tumors.

This Submission was made 30 days ahead of the schedule previously announced on March 9, 2021.

This IND represents a Key Milestone of the program, which brings to the clinic the first target derived from the Kiromic’s AI and Bioinformatics target prediction platform.

Kiromic now expects that it will be able to deliver a first in human patient dosing by the end of the third quarter of 2021 Kiromic, an organization that is driven to achieve scientific breakthroughs, dedicated significant resources to the IND submission in an effort to achieve the optimal clinical trial design on the fastest possible timeline.

IQVIA (https://www.iqvia.com/) will be managing our clinical trial sites as the CRO (Clinical Research Organization). Leading global sites are lining up to be the first to dose our KB-ISM live cell therapies for solid tumors expressing IsoMesothelin.

IQVIA is an industry driver in data technology and advanced analytics, designed to produce and develop optimal clinical trial outcomes.

Site announcements are expected within the next few weeks.

Since Kiromic BioPharma’s Isoform 2 Mesothelin (KB-ISM) is off-the-shelf, it can be pre-manufactured like a typical drug, even though it is a living cellular therapy. This industry leading innovation is due to Kiromic’s proprietary manufacturing and cryopreservation processing techniques.