The US Food and Drug Administration (FDA) has approved Orum Therapeutics’ investigational new drug (IND) application for ORM-1153, a new cluster of differentiation 123-G1 to S phase transition protein 1 (CD123-GSPT1) degrader-antibody conjugate, enabling the start of a Phase I clinical trial.
Orum’s first-in-human trial will target patients with relapsed or refractory acute myeloid leukaemia (AML) and other haematologic malignancies and is expected to commence by the end of 2026.
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ORM-1153 leverages Orum’s TPD² technology to deliver a targeted GSPT1 degrader payload to CD123-expressing cells. This method aims to facilitate the degradation of GSPT1 within these cells.
The upcoming multi-centre study will focus on evaluating the tolerability, safety, pharmacokinetics, pharmacodynamics, and preliminary anti-tumour activity of this treatment in an initial cohort of approximately 42 patients at US clinical sites, with plans for potential expansion to other regions.
Orum Therapeutics chief medical officer Olaf Christensen said: “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 haematologic malignancies.
“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 haematologic malignancies.”
Preclinical data shared at the American Association for Cancer Research Annual Meeting 2026 highlighted ORM-1153’s wide-ranging activity in various AML models, including in primary AML patient samples and TP53-relevant models. These studies also demonstrated the therapy’s low-dose in vivo activity and encouraging repeat-dose tolerability.
The company is progressing its GSPT1-focused TPD² initiatives and creating new degrader payloads to enhance the possibilities of targeted protein degradation.
Orum’s payloads are engineered to specifically degrade crucial intracellular proteins, providing a highly focused strategy for addressing challenging diseases.
