On August 23, 2026 Orum Therapeutics ("Orum" or the "Company") (KRX: 475830), a biotechnology company pioneering the field of degrader-antibody conjugates (DACs), reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ORM-1153, a CD123-GSPT1 DAC. Orum plans to initiate a first-in-human Phase 1 study of ORM-1153 in patients with relapsed or refractory acute myeloid leukemia (AML) and other hematologic malignancies by the end of 2026.
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"FDA clearance of the IND for ORM-1153 is an important milestone for Orum, bringing another first-in-class DAC into the clinic and extending our approach into CD123-expressing hematologic malignancies," said Olaf Christensen, M.D., Chief Medical Officer of Orum Therapeutics. "By combining cell-selective delivery with targeted protein degradation in a single molecule, we believe ORM-1153 has the potential to improve treatment efficacy and tolerability for patients with severe hematologic malignancies."
ORM-1153 uses Orum’s TPD² approach to deliver a GSPT1 degrader payload to CD123-expressing cells, enabling targeted degradation of GSPT1. In preclinical studies presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, ORM-1153 demonstrated broad activity across AML models, including activity in primary AML patient samples and TP53-relevant models, as well as low-dose in vivo activity and favorable repeat-dose tolerability.
The first-in-human Phase 1 study will assess the safety and tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of ORM-1153 in patients with relapsed or refractory AML and other hematologic malignancies. The multicenter study is expected to enroll approximately 42 patients initially at U.S. clinical sites, with potential expansion to other regions.
Orum will host a conference call on Monday, August 24, at 7:00 a.m. KST (Sunday, August 23, at 6:00 p.m. EDT) to discuss the ORM-1153 IND clearance and provide a high-level overview of the Phase 1 clinical study. Conference call details are available at View Source
About Orum’s TPD² Approach
Orum’s unique Dual-Precision Targeted Protein Degradation (TPD²) approach builds novel targeted protein degraders combined with the precise cell delivery mechanisms of antibodies to generate innovative, first-in-class, cell-selective TPDs for the treatment of cancer and other serious diseases. Orum has developed new targeted protein degrader payloads to specifically degrade an intracellular target protein within cancer cells via the E3 ubiquitin ligase pathway. Conjugated to antibodies, the payloads are designed to be delivered specifically to target cells and precisely degrade the intracellular target protein of interest.
(Press release, Orum Therapeutics, AUG 23, 2026, View Source [SID1234670284])