BOSTON and DAEJEON, South Korea, Aug. 22, 2026 (GLOBE NEWSWIRE) -- Orum Therapeutics ("Orum" or the "Company") (KRX: 475830), a biotechnology company pioneering the field of degrader-antibody conjugates (DACs), today announced 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.
"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) 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 https://www.orumrx.com/events.
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.
About Orum Therapeutics
Orum Therapeutics is a public biotech pioneering the development of cell-specific, targeted protein degraders (TPD²) with the precision of antibody targeting to develop the next generation of degrader-antibody conjugates (DACs) for oncology and beyond. The company is advancing its GSPT1-directed TPD² programs and developing novel degrader payloads to expand the potential of targeted protein degradation. Orum's novel targeted protein degrader payloads are designed to selectively degrade key intracellular proteins, offering a highly targeted approach to treating difficult-to-treat diseases. Orum is located in Daejeon, South Korea, and Lexington, MA, US. For more info, visit www.orumrx.com
Orum Therapeutics Forward-Looking Statements
This press release contains forward-looking statements that are based on the current expectations and beliefs of Orum Therapeutics, Inc. ("Orum"). Statements in this release regarding matters that are not historical facts, including, but not limited to, statements relating to the potential therapeutic value of ORM-1153 and Orum's TPD² approach; the expected initiation, timing, design, enrollment, conduct, and results of clinical trials of ORM-1153; the projected number of patients and the location of clinical trial sites; the successful translation of preclinical findings into clinical results; the potential indications for ORM-1153; the potential for ORM-1153 to address unmet medical needs in AML or other hematologic malignancies; the advancement of Orum's GSPT1-directed TPD² programs; and the development of additional novel degrader payloads and their potential benefits, are forward-looking statements.
These forward-looking statements are based on management's expectations and assumptions as of the date of this release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, the uncertainty of success in research and development activities; risks related to clinical trials, including potential delays, safety issues, enrollment challenges, or negative results; competition from alternative therapies; risks related to regulatory review and approval; risks related to third-party manufacturing and development activities; and risks related to the recruitment and retention of key employees, fluctuating markets and economic conditions, and future fundraising. The forward-looking statements in this release speak only as of the date of this release, and Orum undertakes no obligation to update or revise any of the statements. Orum cautions investors not to place considerable reliance on the forward-looking statements contained in this release.
