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Empaveli

(Magrolimab)

Phase 3Monoclonal antibody

Magrolimab is used to treat a blood disorder called cold agglutinin disease, where the body's immune system mistakenly attacks and destroys its own red blood cells, causing anemia and fatigue.[1] Empaveli is currently being investigated across 22 indications[3], with its most advanced program in Phase 3.[1]

Empaveli is one of 511 small molecule programs targeting Lymphoma. It is currently in Phase 3.

22

Indications

29

Total Trials

0

Active Trials

510

Competitors

Pipeline

Status by Indication[3][1]

Indication

LymphomaActive, not recruiting

Brain CancerActive, not recruiting

Hodgkins LymphomaActive, not recruiting

NeuroblastomaActive, not recruiting

Triple-Negative Breast CancerActive, not recruiting

Classic Hodgkin LymphomaActive, not recruiting

Metastatic Colorectal CancerActive, not recruiting

B-Cell Non-Hodgkins LymphomaActive, not recruiting

Brain NeoplasmActive, not recruiting

Myelodysplastic SyndromeActive, not recruiting

LymphomaPhase 1/Phase 2

Active, not recruiting

Brain CancerPhase 1

Active, not recruiting

Hodgkins LymphomaPhase 2

Active, not recruiting

NeuroblastomaPhase 1

Active, not recruiting

Triple-Negative Breast CancerPhase 2

Active, not recruiting

Classic Hodgkin LymphomaPhase 2

Active, not recruiting

Metastatic Colorectal CancerPhase 2

Active, not recruiting

B-Cell Non-Hodgkins LymphomaPhase 1

Active, not recruiting

Brain NeoplasmPhase 1

Active, not recruiting

Myelodysplastic SyndromePhase 3

Active, not recruiting

Showing 10 of 22 indications

Competition

Competitive Landscape

1774 competitors in Lymphoma

#DrugCompanyPhaseTrials

Empaveli

Blenoxane

SSequus Pharmaceuticals

Oncaspar

Zofran

Wellcovorin

GGlaxo Dba Glaxosmithkline

Tafasitamab

CAR-T

HHebei Senlang Biotechnology Inc., Ltd.

Rhg-CSF

CCSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

PD-1 Monoclonal Antibody

SSichuan Baili Pharmaceutical Co., Ltd.

Immune Checkpoint Inhibitor

IImmuneSensor Therapeutics Inc.

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

Clinical

Trials by Indication[1]

Acute Myeloid Leukemia4 trials

US Expanded Access Program for Magrolimab in Patients With Relapsed or Refractory Acute Myeloid Leukemia

No longer available· Gilead logo

Gilead··NCT05627466

Study of Magrolimab in Combination With Azacitidine Versus Physician's Choice of Venetoclax in Combination With Azacitidine or Intensive Chemotherapy in Patients With TP53 Mutant Acute Myeloid Leukemia That Have Not Been Treated

Terminated· Gilead logo

Gilead·Phase 3·NCT04778397·258 enrolled

Study of Magrolimab Versus Placebo in Combination With Venetoclax and Azacitidine in Participants With Acute Myeloid Leukemia

Terminated· Gilead logo

Gilead·Phase 3·NCT05079230·378 enrolled

Show 1 more trial

Magrolimab, Azacitidine, and Venetoclax for the Treatment of Acute Myeloid Leukemia

Terminated·MM.D. Anderson Cancer Center·Phase 1/2·NCT04435691·110 enrolled

Lymphoma3 trials

Trial of Magrolimab (Hu5F9-G4) in Combination With Rituximab or Rituximab + Chemotherapy in Participants With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

Terminated· Gilead logo

Gilead·Phase 1/2·NCT02953509·178 enrolled

An Open-Label, Single Center Phase 2 Study of Magrolimab, Rituximab and Radiation as Bridging Strategy Before CAR T-Cell Therapy in Patients With Relapsed or Refractory Large B-cell Lymphoma

Withdrawn·MM.D. Anderson Cancer Center·Phase 2·NCT05929716

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

Urothelial Carcinoma2 trials

Magrolimab in Combination With Cytotoxic Chemotherapy in Advanced Urothelial Carcinoma

Withdrawn·IInsel Gruppe AG, University Hospital Bern·Phase 1·NCT05738161

Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC)

Completed· Roche logo

Roche·Phase 1/2·NCT03869190·272 enrolled

Metastatic Colorectal Cancer1 trial

Study of Magrolimab Given Together With FOLFIRI/Bevacizumab (BEV) in Participants With Previously Treated Advanced Inoperable Metastatic Colorectal Cancer (mCRC)

Terminated· Gilead logo

Gilead·Phase 2·NCT05330429·77 enrolled

Newly Diagnosed1 trial

Magrolimab Plus Intensive Chemotherapy in Newly Diagnosed AML or HR-MDS

Withdrawn·UUwe Platzbecker·Phase 2·NCT05829434

18 more indications

B-cell Malignancies1 trial

Venetoclax With Obinutuzumab and Magrolimab (VENOM) in Relapsed and Refractory Indolent B-cell Malignancies

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT04599634·11 enrolled

Head and Neck Squamous Cell Carcinoma1 trial

Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma

Terminated· Gilead logo

Gilead·Phase 2·NCT04854499·193 enrolled

Treatment1 trial

A Study of Sabatolimab and Magrolimab-based Treatment in AML or Higher Risk MDS Participants

Withdrawn· Novartis logo

Novartis·Phase 1/2·NCT05367401

Squamous Cell Carcinoma1 trial

Phase II Trial of Magrolimab and Cetuximab With Pembrolizumab or Docetaxel for Recurrent/Metastatic Head Neck Squamous Cell Carcinoma

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT06046482·4 enrolled

MDS1 trial

Magrolimab in Combination with Azacitidine After Allogeneic HCTin Treating Patients with High-Risk AML or MDS

Withdrawn·—·Phase 1·NCT05823480

Patients With Solid Tumors1 trial

Study of Magrolimab in Patients With Solid Tumors

Terminated· Gilead logo

Gilead·Phase 2·NCT04827576·106 enrolled

Triple-Negative Breast Cancer1 trial

Study of Magrolimab Combination Therapy in Patients With Non-Surgically Removable Locally Advanced or Metastatic Triple-Negative Breast Cancer

Terminated· Gilead logo

Gilead·Phase 2·NCT04958785·92 enrolled

Myelodysplastic Syndrome1 trial

Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)

Terminated· Gilead logo

Gilead·Phase 3·NCT04313881·539 enrolled

Prostate Cancer1 trial

Testing the Addition of Immunotherapy With Hu5F9-G4 (Magrolimab) to the Usual PARP Inhibitor, Olaparib for Treatment of Metastatic or Recurrent Breast or Castrate-Resistant Prostate Cancer With BRCA Mutations

Withdrawn·NNational Cancer Institute (NCI)·Phase 1·NCT05807126

Malignant Brain Tumors1 trial

Magrolimab in Children and Adults With Recurrent or Progressive Malignant Brain Tumors

Completed·UUniversity of California, San Francisco·Phase 1·NCT05169944·13 enrolled

Myelodysplastic Syndromes1 trial

A Study of Oral Decitabine/Cedazuridine in Combination With Magrolimab in Participants With Intermediate- to Very High-Risk Myelodysplastic Syndromes (MDS)

Terminated·AAstex Pharmaceuticals, Inc.·Phase 2·NCT05835011·2 enrolled

Multiple Myeloma1 trial

Study of Magrolimab Combinations in Patients With Relapsed/Refractory Multiple Myeloma

Terminated· Gilead logo

Gilead·Phase 2·NCT04892446·36 enrolled

Colorectal Cancer1 trial

Study of Magrolimab (Hu5F9-G4) in Combination With Cetuximab in Participants With Solid Tumors and Advanced Colorectal Cancer

Completed· Gilead logo

Gilead·Phase 1/2·NCT02953782·78 enrolled

Hematological Malignancies1 trial

Magrolimab Monotherapy or Magrolimab in Combination With Azacitidine in Participants With Hematological Malignancies

Terminated· Gilead logo

Gilead·Phase 1·NCT03248479·258 enrolled

Ovarian Cancer1 trial

Study of Magrolimab (Hu5F9-G4) in Combination With Avelumab in Solid Tumor Participants and Checkpoint-Inhibitor-Naive Ovarian Cancer Participants Who Progress Within 6 Months of Prior Platinum Chemotherapy

Completed· Gilead logo

Gilead·Phase 1·NCT03558139·34 enrolled

Myeloid Malignancies1 trial

Study of Magrolimab Combinations in Participants With Myeloid Malignancies

Terminated· Gilead logo

Gilead·Phase 2·NCT04778410·54 enrolled

High-Risk Neuroblastoma1 trial

Phase 1 Trial of Hu5F9-G4 (Magrolimab) Combined With Dinutuximab in Children and Young Adults With Relapsed and Refractory Neuroblastoma or Relapsed Osteosarcoma

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT04751383·12 enrolled

Hodgkin Lymphoma1 trial

A Phase 2 Study of Magrolimab and Pembrolizumab in Relapsed or Refractory Classic Hodgkin Lymphoma

Terminated·SStanford University·Phase 2·NCT04788043·8 enrolled

Sources

References

[1]
ClinicalTrials.gov — 29 trial records for Magrolimab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Magrolimab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Magrolimab. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Gilead company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Leukocyte Surface Antigen CD47 Inhibitor[2]
Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Gilead

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