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Kiromic BioPharma announced the completion of the chPD1 licensing agreement with Longwood University. "Longwood University is proud to have completed this chPD1 licensing agreement with Kiromic. We believe that Kiromic has a strong Allogenic Off-The-Shelf CAR-T program which will be even stronger with chPD1. The role that chPD1 plays in the modulation of the tumor micro-environment (TME) can never be underestimated when treating solid tumors," says Dr. Amorette Barber, PhD, Associate Professor of Biology and Director of the Office of Student Research at Longwood University. "The completion of the licensing agreement for chPD1 marks a major milestone for Kiromic CAR-T development. With chPD1, we believe our chimeric PD1 CAR-T will be able to overcome the challenging tumor micro-environment (TME) which has plagued other CAR-T programs," says Dr. Maurizio Chiriva-Internati, PhD, CEO of Kiromic BioPharma.

Kiromic BioPharma 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 the company's 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 GMP manufacturing test batch optimization and qualification studies are proceeding as scheduled.

Kiromic BioPharma announced the submission of two investigational new drug applications with the U.S. Food and Drug Administration for the initiation of: Phase 1 clinical trial of an intravenously administered allogenic CAR-T for epithelial ovarian carcinoma and malignant pleural mesothelioma and; Phase 1 clinical trial of an intrapleural/intraperitoneal administered allogenic CAR-T for EOC and MPM. Kiromic's proprietary PD1 Gamma-delta CAR-T cell therapy is a novel method for "off-the-shelf" allogeneic CAR T cells derived from healthy donors. We believe our proprietary gamma-delta T cell manufacturing and distribution will offer significant advantages over competitive manufacturing technologies. The initial dose escalation component of each CAR-T trial is projected to enroll approximately 12 patients over 4 months at two sites. The first in-human dosing is targeted for 1Q-2021.