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Poteligeo

(Mogamulizumab)

Phase 3Monoclonal antibody

KKyowa Kirin, Inc.

Mogamulizumab is used to treat certain types of blood cancers, specifically cutaneous T-cell lymphomas like mycosis fungoides and Sézary syndrome, which are cancers of immune cells in the skin.[1] Poteligeo is currently being investigated across 8 indications[3], with its most advanced program in Phase 3.[1]

Poteligeo is one of 80 small molecule programs targeting Sezary's disease. It is currently in Phase 3.

8

Indications

22

Total Trials

9

Active Trials

79

Competitors

Pipeline

Status by Indication[3][1]

Indication

Sezary's DiseaseUnknown

Sezary SyndromeRecruiting

Adult T-Cell Leukemia/lymphomaRecruiting

Mycosis FungoidesTerminated

LymphomaTerminated

Folliculotropic Mycosis FungoidesRecruiting

Cutaneous T-Cell LymphomaCompleted

CTCLActive, not recruiting

Sezary's DiseasePreclinical

Unknown

Sezary SyndromePhase 2

Recruiting

Adult T-Cell Leukemia/lymphomaPhase 2

Recruiting

Mycosis FungoidesPhase 2

Terminated

LymphomaPhase 2

Terminated

Folliculotropic Mycosis FungoidesPhase 2

Recruiting

Cutaneous T-Cell LymphomaPhase 3

Completed

CTCLPhase 2

Active, not recruiting

Competition

Competitive Landscape

401 competitors in Lymphoma

#DrugCompanyPhaseTrials

Poteligeo

KKyowa Kirin, Inc.

Cabenuva

Norvir

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Kenalog

BBausch Health Americas, Inc.

Nuvigil

NNuvo Research GmbH

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

Decadron

QQuince Therapeutics S.p.A.

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Systemic Therapy

Bristol-Myers Squibb

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Recruiting

Sezary Syndrome

NCT04256018

Q1 2027

Phase 2Recruiting

Cutaneous T-Cell Lymphoma

NCT04128072

Phase 1Recruiting

Adult T-Cell Leukemia/lymphoma

NCT04848064

Q2 2027

Phase 2Recruiting

Cutaneous T-Cell Lymphoma

NCT05956041

Q4 2027

Phase 2Recruiting

Lymphoma

NCT05996185

Clinical

Trials by Indication[1]

Lymphoma3 trials

Testing the Addition of an Anti-cancer Drug, Hu5F9-G4 (Magrolimab), to the Usual Chemotherapy Treatment (Mogamulizumab) in T-Cell (a Type of Immune Cell) Lymphoma That Has Returned After Treatment or Does Not Respond to Treatment

Terminated·NNational Cancer Institute (NCI)·Phase 1/2·NCT04541017·8 enrolled

Study of Mogamulizumab With DA-EPOCH or CHOEP in Patients With Aggressive T-cell Lymphoma

Recruiting·YYale University·Phase 2·NCT05996185·22 enrolled

Mogamulizumab and Pembrolizumab in Treating Patients With Relapsed or Refractory Diffuse Large B Cell Lymphoma

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT03309878·8 enrolled

Mycosis Fungoides3 trials

Mogamulizumab and Brentuximab Vedotin in CTCL and Mycosis Fungoides

Recruiting·UUniversity of Alabama at Birmingham·Phase 1·NCT05414500·10 enrolled

Phase I Study of Recombinant Human IL-15 (rhIL-15) and Mogamulizumab for People With Refractory or Relapsed Adult T-Cell Leukemia and Mycosis Fungoides/Sezary Syndrome

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT04185220·6 enrolled

Mogamulizumab and Extracorporeal Photopheresis for the Treatment of Sezary Syndrome or Mycosis Fungoides

Terminated·EEmory University·Phase 1/2·NCT04676087·5 enrolled

Cutaneous T-cell lymphoma3 trials

Pembrolizumab and Mogamulizumab in Advanced-stage, Relapsed/Refractory Cutaneous T-cell Lymphomas

Recruiting·UUniversity of Michigan Rogel Cancer Center·Phase 2·NCT05956041·23 enrolled

Anti-CCR4 Monoclonal Antibody (Mogamulizumab) and Total Skin Electron Beam Therapy (TSEB) in Patients With Stage IB-IIB Cutaneous T-Cell Lymphoma

Recruiting·EEuropean Organisation for Research and Treatment of Cancer - EORTC·Phase 2·NCT04128072·43 enrolled

An Open-Label, Multicenter, Single Arm Study to Evaluate the Efficacy and Safety of Anti-CCR4 Monoclonal Antibody Mogamulizumab (KW-0761) in Chinese Subjects With Mycosis Fungoides or Sézary Syndrome Previously Treated With Systemic Therapy

Completed·KKyowa Kirin China Pharmaceutical Co., Ltd.·Approved·NCT06285370·23 enrolled

Adult T-Cell Leukemia/lymphoma2 trials

Third-Party Natural Killer Cells and Mogamulizumab for the Treatment of Relapsed or Refractory Cutaneous T-cell Lymphomas or Adult T-Cell Leukemia/Lymphoma

Recruiting·JJohn Reneau·Phase 1·NCT04848064·12 enrolled

A Study of Mogamulizumab to Prevent Adult T-cell Leukemia/Lymphoma in People With HTLV-1

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT06698003·134 enrolled

Locally Advanced or Metastatic Solid Tumors2 trials

Study of Mogamulizumab + Nivolumab in Subjects w/Locally Advanced or Metastatic Solid Tumors

Completed·KKyowa Kirin, Inc.·Phase 1/2·NCT02705105·114 enrolled

KHK2455 Alone and in Combination With Mogamulizumab in Subjects With Locally Advanced or Metastatic Solid Tumors

Completed·KKyowa Kirin, Inc.·Phase 1·NCT02867007·36 enrolled

9 more indications

Non-Small Cell Lung Cancer1 trial

Study of Mogamulizumab + Docetaxel in Subjects With Non-small Cell Lung Cancer

Completed·KKyowa Kirin, Inc.·Phase 1·NCT02358473·13 enrolled

Advanced Solid Tumors1 trial

Study of Mogamulizumab + MEDI4736 (Durvalumab) and Mogamulizumab + Tremelimumab in Subjects w/ Advanced Solid Tumors

Completed·KKyowa Kirin, Inc.·Phase 1·NCT02301130·64 enrolled

CTCL1 trial

Mogamulizumab Q4week Dosing in Participants With R/R CTCL

Active, not recruiting·KKyowa Kirin, Inc.·Phase 2·NCT04745234·34 enrolled

Metastatic Solid Tumors1 trial

Safety, Tolerability, and Immunoregulatory Activity of Mogamulizumab (KW-0761) in Subjects With Advanced and/or Metastatic Solid Tumors

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1/2·NCT02281409·17 enrolled

Recurrent Cancer1 trial

Phase Ia/Ib Multicenter Trial of Mogamulizumab for Advanced or Recurrent Cancer.

Unknown status·—·Phase 1·NCT01929486·58 enrolled

Combination Therapy1 trial

Study of Pre-operative Combination Therapy With Mogamulizumab and Nivolumab Against Solid Cancer Patients

Completed·OOsaka University·Phase 1·NCT02946671·16 enrolled

Folliculotropic Mycosis Fungoides1 trial

A Phase II Study of Combination Extracorporeal Photopheresis (ECP) and Mogamulizumab in Erythrodermic CTCL

Recruiting·CCity of Hope Medical Center·Phase 2·NCT04930653·34 enrolled

Sezary Syndrome1 trial

A Phase 2 Single Center, Single Arm, Open Label Mogamulizumab Combined Upfront With Low Dose Total Skin Electron Beam Therapy (LD TSEBT) in Patients With Mycosis Fungoides (MF) and Sézary Syndrome (SS)

Recruiting·SStanford University·Phase 2·NCT04256018·30 enrolled

Mycosis Fungoides and Sézary Syndrome1 trial

Prospective Research Based Observational Study of Poteligeo® Experience in the Real World in Adult Patients With Mycosis Fungoides and Sézary Syndrome

Completed·KKyowa Kirin Pharmaceutical Development Ltd··NCT05455931·73 enrolled

Sources

References

[1]
ClinicalTrials.gov — 22 trial records for Mogamulizumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Mogamulizumab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Mogamulizumab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Kyowa Kirin, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: C-C Chemokine Receptor Type 4 Cross-Linking Agent[2]
Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: KKyowa Kirin, Inc.

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