Orum Therapeutics Receives FDA Clearance to Begin Clinical Development of ORM-1153

Orum Therapeutics announced on August 22, 2026, that the U.S. FDA cleared its Investigational New Drug (IND) application for ORM-1153.

ORM-1153 is a CD123-targeting degrader-antibody conjugate (DAC) that delivers a GSPT1-degrading payload into cancer cells. The approach combines antibody targeting with targeted protein degradation.

The company plans to begin a first-in-human Phase 1 trial by the end of 2026 in patients with relapsed or refractory acute myeloid leukemia (AML) and other CD123-positive blood cancers.

The planned multicenter study is expected to initially enroll about 42 patients at U.S. sites. Researchers will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity.

Preclinical findings presented at AACR and ASH indicated potent, CD123-dependent activity—including in TP53-mutant AML models—and a potentially favorable effect on normal hematopoietic cells. These findings remain preliminary and require clinical confirmation.

The FDA clearance is a regulatory milestone, not evidence that ORM-1153 is effective or approved for patient treatment.