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DRUG:

Saccovid (efprezimod alfa)

i
Other names: MK-7110, CD24Fc, CD24IgG, HAS-CD24, CD24Fc-fusion protein, Recombinant CD24 IgG1 Fc fusion protein, Recombinant human CD24FcIg
Associations
Company:
Merck (MSD)
Drug class:
NF-κB inhibitor, Siglec10 agonist
Associations
1year
A Phase 2 Trial of CD24Fc for Prevention of Graft-vs-Host Disease. (PubMed, Blood)
Patients who undergo human leukocyte antigen-matched unrelated donor (MUD) allogeneic hematopoietic stem cell transplantation (HSCT) with myeloablative conditioning for hematologic malignancies often develop acute graft-vs-host disease (GVHD) despite standard calcineurin inhibitor-based prophylaxis in combination with methotrexate. The multidose regimen of CD24Fc was well tolerated with no DLTs and was associated with high rates of severe acute GVHD-free survival after myeloablative MUD HSCT. This trial was registered at ClinicalTrials.gov as NCT02663622.
Clinical • P2 data • Journal
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CD24 (CD24 Molecule)
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methotrexate • Saccovid (efprezimod alfa)
over1year
CD24-Fc suppression of immune related adverse events in a therapeutic cancer vaccine model of murine neuroblastoma. (PubMed, Front Immunol)
This study illustrates that the combination of Myc suppressed whole tumor cell vaccination with checkpoint inhibitors is an effective therapy, but occult immune infiltrates are induced in several organ systems in a mouse neuroblastoma model. The systemic administration of CD24-Fc suppresses autoimmune tissue responses, but appropriate timing of administration is critical for maintaining efficacy of the therapeutic vaccine.
Preclinical • Journal • Adverse events
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CD24 (CD24 Molecule)
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Saccovid (efprezimod alfa)
over2years
CD24Fc for the Treatment of Immune Related Adverse Events in Patients With Advanced Solid Tumors, TIRAEC Study (clinicaltrials.gov)
P1/2, N=3, Terminated, Tianhong Li | N=78 --> 3 | Active, not recruiting --> Terminated; Terminated early by the Sponsor due to the sponsor change.
Enrollment change • Trial termination • Adverse events
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CD24 (CD24 Molecule)
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Saccovid (efprezimod alfa)
3years
Trial termination
|
HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • HLA-B (Major Histocompatibility Complex, Class I, B) • HLA-C (Major Histocompatibility Complex, Class I, C)
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methotrexate • Saccovid (efprezimod alfa)
over3years
Clinical • Enrollment change
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HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1)
|
methotrexate • Saccovid (efprezimod alfa)
over3years
CD24Fc for the Treatment of Immune Related Adverse Events in Patients With Advanced Solid Tumors, TIRAEC Study (clinicaltrials.gov)
P1/2, N=78, Active, not recruiting, Tianhong Li | Recruiting --> Active, not recruiting | Trial completion date: Jun 2023 --> Feb 2022 | Trial primary completion date: Oct 2022 --> Feb 2021
Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Adverse events
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CD24 (CD24 Molecule)
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Saccovid (efprezimod alfa)
over3years
Clinical • New P3 trial
|
HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1)
|
methotrexate • Saccovid (efprezimod alfa)
over3years
Trial completion
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HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1)
|
methotrexate • Saccovid (efprezimod alfa)
over3years
CATHY: CD24Fc for the Prevention of Acute Graft Versus Host Disease (GVHD) Following Myeloablative Hematopoietic Stem Cell Transplantation (HSCT) (MK-7110-005) (clinicaltrials.gov)
P3, N=180, Active, not recruiting, OncoImmune, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Feb 2024 --> Nov 2021 | Trial primary completion date: Aug 2023 --> Nov 2021
Clinical • Enrollment closed • Trial completion date • Trial primary completion date
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HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1)
|
methotrexate • Saccovid (efprezimod alfa)
over3years
Phase II Trial of CD24Fc for the Prevention of Acute Graft-Versus-Host Disease (GVHD) Following Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) (MK-7110-002) (clinicaltrials.gov)
P2, N=44, Active, not recruiting, OncoImmune, Inc. | Completed --> Active, not recruiting | Trial completion date: Jan 2021 --> May 2021
Enrollment closed • Trial completion date
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HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1)
|
methotrexate • Saccovid (efprezimod alfa)
over3years
CATHY: CD24Fc for the Prevention of Acute Graft Versus Host Disease (GVHD) Following Myeloablative Hematopoietic Stem Cell Transplantation (HSCT) (MK-7110-005) (clinicaltrials.gov)
P3, N=180, Recruiting, OncoImmune, Inc. | Trial completion date: Dec 2024 --> Feb 2024 | Trial primary completion date: Dec 2023 --> Aug 2023
Clinical • Trial completion date • Trial primary completion date
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HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1)
|
methotrexate • Saccovid (efprezimod alfa)
almost4years
Trial completion • Trial completion date
|
HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1)
|
methotrexate • Saccovid (efprezimod alfa)
almost4years
Trial completion date
|
HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1)
|
methotrexate • Saccovid (efprezimod alfa)
4years
Clinical • Enrollment open • Adverse events
|
CD24 (CD24 Molecule)
|
Saccovid (efprezimod alfa)
4years
Clinical • Enrollment open
|
HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1)
|
methotrexate • Saccovid (efprezimod alfa)
4years
Clinical • New P1/2 trial • Adverse events
|
CD24 (CD24 Molecule)
|
Saccovid (efprezimod alfa)