Orum Therapeutics(475830) said on the 23rd that the U.S. Food and Drug Administration (FDA) approved the investigational new drug (IND) application for a phase 1 clinical trial of the acute myeloid leukemia treatment candidate "ORM-1153."
Orum Therapeutics plans to begin a first-in-human phase 1 clinical trial of ORM-1153 by the end of this year for patients with relapsed or refractory acute myeloid leukemia (AML) and other hematologic cancers, following this approval.
ORM-1153 is a degradation-activating conjugate (DAC) that combines an antibody-drug conjugate (ADC) with a targeted protein degrader (TPD). It attaches a protein-degrading payload to an antibody that homes to cancer cells, selectively degrading the GSPT1 protein essential for cancer cell survival.
Olaf Christensen, chief medical officer (CMO) at Orum Therapeutics, said, "The IND approval for ORM-1153 is an important milestone that brings another first-in-class DAC into the clinic and expands our research targeting CD123-expressing hematologic cancers."
Christensen added, "By combining precise cell-selective drug delivery technology with targeted protein degradation technology into a single therapy, we believe ORM-1153 has the potential to improve efficacy and tolerability for patients with severe blood cancers."
In preclinical studies presented at the American Association for Cancer Research (AACR) annual meeting in 2026, ORM-1153 showed broad antitumor activity across various acute myeloid leukemia models. Activity was also confirmed in primary cells derived from AML patients and in TP53-related models. It demonstrated in vivo activity even at low doses and showed favorable tolerability with repeat dosing.
This phase 1 trial will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of ORM-1153 in patients with relapsed or refractory acute myeloid leukemia and other hematologic cancers.
The clinical trial is expected to enroll about 42 patients at multiple sites in the United States and may be expanded to other regions in the future.
Meanwhile, Orum Therapeutics will hold a conference call at 7 a.m. on the 24th to explain the IND approval for ORM-1153 and the detailed plan for the phase 1 clinical trial.