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Orum Therapeutics Announces U.S. FDA Clearance of an IND Application for ORM-1153, a Novel CD123-GSPT1 Degrader-Antibody Conjugate

Sat, 22 Aug 2026 20:00:00 -0400

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

Orum Therapeutics Announces U.S. FDA Clearance of an IND Application for ORM-1153, a Novel CD123-GSPT1 Degrader-Antibody Conjugate

Sat, 22 Aug 2026 20:00:00 -0400

“FDA clearance of the IND for ORM-1153 is an important

Orum Therapeutics Announces U.S. FDA Clearance of an IND Application for ORM-1153, a Novel CD123-GSPT1 Degrader-Antibody Conjugate

Sat, 22 Aug 2026 20:00:00 -0400

“FDA clearance of the IND for ORM-1153 is an important

Orum Therapeutics Announces U.S. FDA Clearance of an IND Application for ORM-1153, a Novel CD123-GSPT1 Degrader-Antibody Conjugate

Sat, 22 Aug 2026 20:00:00 -0400

“FDA clearance of the IND for ORM-1153 is an important

Orum Therapeutics Announces U.S. FDA Clearance of an IND Application for ORM-1153, a Novel CD123-GSPT1 Degrader-Antibody Conjugate

Sat, 22 Aug 2026 20:00:00 -0400

“FDA clearance of the IND for ORM-1153 is an important

Orum Therapeutics Announces U.S. FDA Clearance of an IND Application for ORM-1153, a Novel CD123-GSPT1 Degrader-Antibody Conjugate

Sat, 22 Aug 2026 20:00:00 -0400

“FDA clearance of the IND for ORM-1153 is an important

Orum Therapeutics Announces U.S. FDA Clearance of an IND Application for ORM-1153, a Novel CD123-GSPT1 Degrader-Antibody Conjugate

Sat, 22 Aug 2026 20:00:00 -0400

“FDA clearance of the IND for ORM-1153 is an important

Orum Therapeutics Announces U.S. FDA Clearance of an IND Application for ORM-1153, a Novel CD123-GSPT1 Degrader-Antibody Conjugate

Sat, 22 Aug 2026 20:00:00 -0400

“FDA clearance of the IND for ORM-1153 is an important

Orum Therapeutics Announces U.S. FDA Clearance of an IND Application for ORM-1153, a Novel CD123-GSPT1 Degrader-Antibody Conjugate

Sat, 22 Aug 2026 20:00:00 -0400

“FDA clearance of the IND for ORM-1153 is an important

Orum Therapeutics Announces U.S. FDA Clearance of an IND Application for ORM-1153, a Novel CD123-GSPT1 Degrader-Antibody Conjugate

Sat, 22 Aug 2026 20:00:00 -0400

“FDA clearance of the IND for ORM-1153 is an important

Orum Therapeutics Announces U.S. FDA Clearance of an IND Application for ORM-1153, a Novel CD123-GSPT1 Degrader-Antibody Conjugate

Sat, 22 Aug 2026 20:00:00 -0400

“FDA clearance of the IND for ORM-1153 is an important

Orum Therapeutics Announces U.S. FDA Clearance of an IND Application for ORM-1153, a Novel CD123-GSPT1 Degrader-Antibody Conjugate

Sat, 22 Aug 2026 20:00:00 -0400

“FDA clearance of the IND for ORM-1153 is an important

Orum Therapeutics Announces U.S. FDA Clearance of an IND Application for ORM-1153, a Novel CD123-GSPT1 Degrader-Antibody Conjugate

Sat, 22 Aug 2026 20:00:00 -0400

“FDA clearance of the IND for ORM-1153 is an important

Orum Therapeutics Announces U.S. FDA Clearance of an IND Application for ORM-1153, a Novel CD123-GSPT1 Degrader-Antibody Conjugate

Sat, 22 Aug 2026 20:00:00 -0400

“FDA clearance of the IND for ORM-1153 is an important

Orum Therapeutics Announces U.S. FDA Clearance of an IND Application for ORM-1153, a Novel CD123-GSPT1 Degrader-Antibody Conjugate

Sat, 22 Aug 2026 20:00:00 -0400

“FDA clearance of the IND for ORM-1153 is an important

Orum Therapeutics Announces U.S. FDA Clearance of an IND Application for ORM-1153, a Novel CD123-GSPT1 Degrader-Antibody Conjugate

Sat, 22 Aug 2026 20:00:00 -0400

“FDA clearance of the IND for ORM-1153 is an important

Orum Therapeutics presents AML drug data at cancer research meeting

Fri, 17 Apr 2026 15:00:44 -0400

Orum Therapeutics (KRX: 475830) presented preclinical data for ORM-1153, a CD123-targeting degrader-antibody conjugate, at the American Association for Cancer Research Annual Meeting 2026. The company is developing the drug candidate for treatment of acute myeloid leukemia and other CD123-positive blood cancers.

The data, presented in two posters, showed activity across primary AML patient samples and in models with TP53 mutations. ORM-1153 demonstrated anti-leukemia activity at low doses with prolonged tumor accumulation and undetectable systemic free payload in preclinical studies.

The drug candidate combines a proprietary CD123 antibody engineered for enhanced internalization with a GSPT1-degrading payload. The design aims to reduce off-target effects

Orum Therapeutics presents AML drug data at cancer research meeting

Fri, 17 Apr 2026 15:00:44 -0400

The drug candidate combines a proprietary CD123 antibody engineered for enhanced internalization with a GSPT1-degrading payload. The design aims to reduce off-target effects

Orum Therapeutics Presents New Preclinical Data at AACR 2026 on ORM-1153, a CD123-Targeting Degrader-Antibody Conjugate, Highlighting Broad Activity in Acute Myeloid Leukemia and the Potential for Imp

Fri, 17 Apr 2026 15:00:00 -0400

ORM-1153, with optimized antibody and linker design, demonstrates improved pharmacology, low-dose in vivo activity, and favorable repeat-dose tolerability
Data show activity across primary acute myeloid leukemia (AML) patient samples and retained activity in TP53-relevant models, indicating the potential for broad activity
Together, the AACR data support continued advancement of ORM-1153 toward clinical development, with a regulatory submission expected in the second half of 2026

BOSTON & DAEJEON, South Korea--(BUSINESS WIRE)-- Orum Therapeutics (“Orum” or the “Company”) (KRX: 475830), a biotechnology company pioneering the field of degrader-antibody conjugates (DACs), today announced the presentation of new preclinical data for ORM-1153, a

Orum Therapeutics Presents New Preclinical Data at AACR 2026 on ORM-1153, a CD123-Targeting Degrader-Antibody Conjugate, Highlighting Broad Activity in Acute Myeloid Leukemia and the Potential for Imp

Fri, 17 Apr 2026 15:00:00 -0400

ORM-1153, with optimized antibody and linker design, demonstrates improved pharmacology, low-dose in vivo activity, and favorable repeat-dose tolerability
Data show activity across primary acute myeloid leukemia (AML) patient samples and retained activity in TP53-relevant models, indicating the potential for broad activity
Together, the AACR data support continued advancement of ORM-1153 toward clinical development, with a regulatory submission expected in the second half of 2026

Orum Therapeutics Presents New Preclinical Data at AACR 2026 on ORM-1153, a CD123-Targeting Degrader-Antibody Conjugate, Highlighting Broad Activity in Acute Myeloid Leukemia and the Potential for Imp

Fri, 17 Apr 2026 15:00:00 -0400

ORM-1153, with optimized antibody and linker design, demonstrates improved pharmacology, low-dose in vivo activity, and favorable repeat-dose tolerability
Data show activity across primary acute myeloid leukemia (AML) patient samples and retained activity in TP53-relevant models, indicating the potential for broad activity
Together, the AACR data support continued advancement of ORM-1153 toward clinical development, with a regulatory submission expected in the second half of 2026

Orum Therapeutics Presents New Preclinical Data at AACR 2026 on ORM-1153, a CD123-Targeting Degrader-Antibody Conjugate, Highlighting Broad Activity in Acute Myeloid Leukemia and the Potential for Imp

Fri, 17 Apr 2026 15:00:00 -0400

ORM-1153, with optimized antibody and linker design, demonstrates improved pharmacology, low-dose in vivo activity, and favorable repeat-dose tolerability
Data show activity across primary acute myeloid leukemia (AML) patient samples and retained activity in TP53-relevant models, indicating the potential for broad activity
Together, the AACR data support continued advancement of ORM-1153 toward clinical development, with a regulatory submission expected in the second half of 2026

Orum Therapeutics adds two directors to board

Mon, 13 Apr 2026 09:00:33 -0400

Orum Therapeutics (KRX: 475830) announced the appointment of Maria Koehler, M.D., Ph.D., and Geoff Meyerson to its board of directors following approval at the company's annual general meeting on March 27.

The biotechnology company, which develops degrader-antibody conjugates, said the appointments bring clinical development and strategic investment expertise as it advances its programs.

Dr. Koehler previously served as chief medical officer at Repare Therapeutics until March 2025 and has held senior oncology development roles at Pfizer, GSK, and AstraZeneca. She led development of IBRANCE (palbociclib) at Pfizer and has more than 20 years of experience in clinical development and regulatory strategy.

Meyerson is

Orum Therapeutics adds two directors to board

Mon, 13 Apr 2026 09:00:33 -0400

The biotechnology company, which develops degrader-antibody conjugates, said the appointments bring clinical development and strategic investment expertise as it advances its programs.

Meyerson is

Orum Therapeutics adds two directors to board

Mon, 13 Apr 2026 09:00:33 -0400

The biotechnology company, which develops degrader-antibody conjugates, said the appointments bring clinical development and strategic investment expertise as it advances its programs.

Meyerson is