Minhua Chu, Managing Partner at TransitionValue Partner, shared a post on X:
“Shenzhen Pregene Biopharma has received Orphan Drug Designation (ODD) from the FDA for its CD19/CD22-targeted CAR-T therapy for the treatment of acute lymphoblastic leukemia (ALL).
Pregene’s CD19/CD22-targeted CAR-T therapy is in preclinical stage. It is currently undergoing an Investigator-Initiated Trial (IIT) in collaboration with a Chinese hospital.
Results show that all six patients receiving the CAR-T therapy for the first time achieved complete remission (CR), with an objective response rate (ORR) of 100% and a minimal residual disease (MRD) negativity rate of 100%.”
More posts featuring Minhua Chu on OncoDaily.