ORM-1153 / Orum Therap - LARVOL DELTA

ORM-1153: A CD123-targeting degrader antibody conjugate with GSPT1-degrading payload exhibits potent preclinical antitumor activity in Acute Myeloid Leukemia (ASH 2025) - "Treatment options for unfit patients withoutactionable mutations are more limited following first-line treatment with the venetoclax / HMA standard-of-care...Currently, there is only one approved ADC for AML therapy:gemtuzumab ozogamicin (GO)... ORM-1153 combines CD123 target specificity with GSPT1 degradation to deliver potent anti-AML activityand a favorable safety profile in preclinical models. These data indicate that ORM-1153 may represent aviable therapeutic agent for the treatment of AML, including TP53-mutant and CD123-positive subtypes,and warrants further investigation in clinical trials."

Preclinical • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CD123 • GSPT1 • IL3RA • TP53

Orum Therapeutics Presents Preclinical Data at ASH 2025 Demonstrating Potent and Selective Antitumor Activity of ORM-1153, a CD123-Targeting Degrader Antibody Conjugate for Acute Myeloid Leukemia (Businesswire) - "The preclinical data presented at ASH show that ORM-1153 drives efficient, CD123-dependent internalization and degradation of GSPT1, resulting in strong and durable antitumor activity in AML models, including TP53-mutant disease. In comparative studies, ORM-1153 demonstrated approximately 1,000-fold higher potency than the unconjugated degrader payload and produced dose-dependent tumor regression in a disseminated AML xenograft model, with complete and durable responses at the highest dose level."

P53mut • Preclinical • Acute Myelogenous Leukemia

Orum Therapeutics will present preclinical data on ORM-1153, a novel CD123-targeted antibody-drug conjugate (ADC) candidate for acute myeloid leukemia (AML). (Korea Biomedical Review) - "ORM-1153 is a next-generation candidate with a novel payload that degrades the GSPT1 protein, inducing cytotoxicity regardless of TP53 mutation. It demonstrated potent, selective anticancer activity in AML cell lines and patient-derived cells while sparing normal hematopoietic cells. The company reported that a single intravenous dose in animal studies significantly reduced tumor burden."

Preclinical • Acute Myelogenous Leukemia

The "TPD² Evolution" Begins in Full Swing… GSPT1 Target Pipeline Unveiled [Google translation] (HIT News) - "Preclinical studies have shown that ORM‑1153 selectively delivers a GSPT1 degradation inducer to tumor cells through this antibody, and exhibits tumor-selective cytotoxicity up to 1,000 times higher than existing small molecule degraders (CC-90009) or single payloads (SMol006), raising expectations before entering clinical trials. In addition, Orum announced that it has confirmed potent anti-tumor activity in preclinical studies of ORM-1023, a protein degradation-based therapeutic currently in development for small cell lung cancer (SCLC) and neuroendocrine tumors....The company is also accelerating development of ORM-1153, aiming for an IND submission next year, and has announced key data to be presented at ASH later this year."

IND • Preclinical • Hematological Malignancies • Neuroendocrine Tumor • Small Cell Lung Cancer

Development of the world's first HER2 antibody-conjugated degrader terminated [Google translation] (new.qq.com) - "On April 28, Orum Therapeutics announced a strategic update to the company's product pipeline, terminating further clinical development of the HER2-targeted GSPT1 antibody-coupled degrader (DAC) ORM-5029, and nominating the next-generation DAC candidate ORM-1153 under development for the treatment of hematological malignancies....After reviewing the existing clinical and preclinical data, Orum decided to terminate the development of ORM-5029."

Discontinued • Pipeline update • Hematological Malignancies • HER2 Breast Cancer

[IPO Alert][Orum Therapeutics] No Good News for Several Years After IPO [Google translation] (PRESS9) - "Orum therapeutics announced that it plans to transfer technology for ORM-5029, which was suspended due to toxicity issues in the low-dose phase 1 clinical trial, in 2026....In addition, Orom Therapeutics announced that it plans to transfer ORM-1023 and ORM-1153, which are still in the discovery stage, in 2026. It seems premature to discuss technology transfer when the substance has not been confirmed."

Commercial • Hematological Malignancies • HER2 Breast Cancer • Small Cell Lung Cancer

Orum Therapeutics invests 30 billion won in research funds for 3 types including ’ORM-5029’ [Google translation] (Medipana) - "It plans to raise the funds through a public offering on the KOSDAQ market in November. According to the Financial Supervisory Service's Electronic Disclosure System on the 7th, Orum Therapeutics plans to use approximately 30 billion won in funds for three projects under research and development, 'ORM-5029', 'ORM-1023', and 'ORM-1153', by 2026. Specifically, it plans to invest 11.3 billion won in 'ORM-5029', a metastatic breast cancer treatment, 9 billion won in 'ORM-1023', a small cell lung cancer treatment, and 9.8 billion won in 'ORM-1153', a blood cancer treatment....The plan is to procure funds for research and development through a KOSDAQ listing scheduled for November. According to the securities report submitted by Orum Therapeutics on the 2nd, the number of shares being offered through this KOSDAQ listing is 3 million, and the range of the desired public offering price per share is 30,000 to 36,000 won."

Financing • Breast Cancer • Hematological Malignancies • HER2 Breast Cancer • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor