FDA cleared Orum Therapeutics’ IND for ORM-1153, a CD123-targeting degrader-antibody conjugate designed to deliver a GSPT1 degrader payload to CD123-expressing cells. The program uses Orum’s Dual-Precision Targeted Protein Degradation (TPD2) approach, combining antibody targeting with targeted degradation. GSPT1 is a translation-related protein implicated in tumor biology, and the therapy concept aims to degrade the target rather than inhibit it. The IND clearance opens the door to clinical testing under FDA oversight. For the targeted degradation field, IND clearance for a new ADC-degrader hybrid underscores how developers are increasingly pairing antibody delivery with precision proteostasis mechanisms to sharpen therapeutic windows.