HOUSTON—Kiromic BioPharma, Inc., an immuno-oncology target discovery and gene-editing company using its proprietary Diamond AI neural network platform to develop novel oncology therapeutics, has announced the completion and certification of its GMP facility in Houston, Texas.
“The in-house capability to manufacture allogenic, off-the-shelf CAR [chimeric antigen receptor] 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,” stated Dr. Maurizio Chiriva-Internati, CEO of Kiromic BioPharma.
The company notes that their GMP facility construction is complete, and certified to meet all FDA-required regulatory guidelines. The facility is ready to support Kiromic’s upcoming first-in-human, off-the-shelf allogenic CAR-T trial. The CAR-T ovarian cancer trials will target chimeric PD1 Gamma-Delta, and Iso-mesothelin. The company also reports that Gamma-Delta-T cell (GDT cell) GMP manufacturing test batch optimization and qualification studies are proceeding as scheduled.
GDT cells are a small fraction of blood lymphocytes, but they are the predominant T cell type in the epithelia. Compared with alpha-beta-T cells (ABT) currently used in CAR therapies, GDT cells are said to be more efficient in killing tumor cells, and more resistant to mechanisms by which solid tumors escape from the immune system.
Unlike ABT cells, manufacturing GDT cells doesn’t require a patient’s blood — GDT cells can be produced using the blood of healthy donors via allogenic cell transfer. And GDT cells will only target the tumor for which they were engineered, leaving non-tumoral cells untouched. The cells are genetically modified to target tumor antigens discovered by Kiromic’s Diamond AI technology, and the company believes that its proprietary gamma-delta T cell manufacturing and distribution will offer significant advantages over competitive manufacturing technologies.
“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,” added Mr. Tony Tontat, chief financial officer and chief operating officer of Kiromic BioPharma.
Kiromic has submitted two Investigational New Drug applications with the FDA. One is for the Phase 1 clinical trial of an intravenously administered allogenic CAR-T for epithelial ovarian carcinoma (EOC) and malignant pleural mesothelioma (MPM); the other is for a Phase 1 clinical trial of an intrapleural/intraperitoneal administered allogenic CAR-T for EOC and MPM.
“It’s an exciting time to see our technology go into the clinic. This is the culmination of +25 years of research and development which has spanned the globe with international contributions and scientific collaborations from the sharpest minds of our time,” explained Chiriva-Internati in a press release. “Our gamma-delta T-cells are designed to offer clinicians a treatment option with: higher efficacy, higher safety (reducing graft vs. host risks), and lower manufacturing and distribution costs vs. cellular therapy technologies of the past.”
The initial dose escalation component of each CAR-T trial is projected to enroll approximately 12 patients over 4 months at two sites, and the dosing is targeted for the first quarter of 2021.