Kiromic BioPharma, Inc. (Nasdaq: KRBP), an immuno-oncology target discovery and gene-editing company, with a proprietary artificial intelligence neural network platform (Diamond AI) to develop novel oncology therapeutics, has announced the completion and certification of its GMP facility in Houston, Texas:
GMP facility construction is complete and certified to meet all FDA required regulatory guidelines.
GMP facility is ready to support our upcoming first in-human, off-the-shelf, allogenic CAR-T trial. The CAR-T ovarian cancer trials will have these targets: chPD1 Gamma-Delta and anti-ISOMSLN.
Gamma-Delta-T cell (GDT cell) GMP manufacturing test batch optimization and qualification studies are proceeding as scheduled.
"The in-house capability to manufacture allogenic, off-the-shelf CAR products removes a layer of complexity in the workflow, which we believe will greatly enhance our ability to move swiftly through our CAR-T trials," says Dr. Maurizio Chiriva-Internati, PhD, CEO of Kiromic BioPharma.
"The key features of the facility have been completed, clearing the path for the production of our off-the-shelf Gamma-Delta-T cells, a novel approach to CAR-T cell therapy, which will be evaluated in the upcoming clinical trials," says David Aguilar, PhD, Head of CMC Manufacturing of Kiromic BioPharma.
"Thanks to the hard work of our scientists, contractor engineers, suppliers, and the third party certifiers, our Houston Facility is completing the final steps needed for launching the next-generation of allogenic, off-the-shelf CAR-T," says Mr. Tony Tontat, CFO, COO of Kiromic BioPharma.
(chPD1: Chimeric PD1; ISOMSLN: Iso-mesothelin; CAR: Chimeric Antigen Receptors)
About Allogenic Gamma-Delta-T cells
GDT cells are a small fraction of blood lymphocytes, but they are the predominant T cell type in epithelia, where they patrol the barrier between the body and the outside world, with their potent multi-anti-pathogen abilities. Compared with alpha-beta-T cells (ABT), currently used in CAR therapies, GDT cells are more efficient in killing tumor cells and more resistant to mechanisms by which solid tumors escape from the immune system.
Furthermore, unlike ABT cells, GDT cells manufacturing does not require the patient’s blood, but can be produced using the blood of healthy donors, a process called allogenic cell transfer. This is possible because, while ABT cells from another individual will attack a patient’s normal organs, GDT cells will only target the tumor target for which they were engineered, leaving non-tumoral cells untouched.
The workflow of CAR-T therapy is as follows:
The GDT cells are grown and purified from the blood of healthy individuals.
The GDT cells are expanded with a proprietary process.
The GDT cells are then genetically modified to target tumor antigens discovered by Kiromic’s Diamond AI technology, resulting in the next generation of CAR-T cell therapy for solid malignancies.
Kiromic BioPharma, Inc. is an immuno-oncology biopharmaceutical company focused on discovering, developing, and commercializing novel immuno-oncology applications through its robust product pipeline. The pipeline development is leveraged through the Company’s proprietary target discovery engine called "DIAMOND." Kiromic's DIAMOND is essentially big data science meeting target identification, dramatically compressing the man-years and the millions of drug development dollars needed to develop a live drug. The Company’s headquarters are located in Houston, TX adjacent to the world’s largest medical center and the MD Anderson Cancer Center.
For more information, please visit Kiromic’s website at:
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