Details of the SBP
| General Information of Synthetic Binding Protein (SBP) (ID: SBP000157) | ||||||
|---|---|---|---|---|---|---|
| SBP Name |
DART MGD-010
|
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| Synonyms |
MGD010; PRV-3279; PRV3279
|
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| Design Method | Traditional methods (Site-directed mutagenesis and/or Directed evolution) | |||||
| Highest Status | Phase II | |||||
| Protein Scaffold Information of This SBP | ||||||
|---|---|---|---|---|---|---|
| Scaffold ID | PS028 | [1] | ||||
| Scaffold Name | DART | |||||
| Scaffold Class | Antibody fragment | |||||
| Fold Type | Beta-Sheets + Loops | |||||
| Binding Target(s) of This SBP (BTS) |
|---|
| BTS Name | Details | Mechanism | Application | Affinity | Research Organization | Ref |
|---|---|---|---|---|---|---|
| Low affinity immunoglobulin gamma Fc region receptor II-b | Modulator | Acute hepatitis A [ICD-11: 1E50.0] | N.A. | MacroGenics | [1] | |
| B-cell antigen receptor complex-associated protein beta chain | Modulator | Acute hepatitis A [ICD-11: 1E50.0];Systemic lupus erythematosus [ICD-11: 4A40.0] | N.A. | MacroGenics | [1] | |
| Clinical Trial Information of This SBP | ||||||
|---|---|---|---|---|---|---|
| NCT02376036 | Click to show the Detail | |||||
| Indication | Healthy | |||||
| Phase | Phase I | |||||
| Title | A Phase I, First-in-Human, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of?MGD010, a CD32B x CD79B Dual Affinity Re-Targeting (DART?) Bi-specific Antibody-Based Molecule, in Healthy Subjects | |||||
| Status | Completed | |||||
| Sponsor | MacroGenics | |||||
| NCT03955666 | Click to show the Detail | |||||
| Indication | Safety | |||||
| Phase | Phase I | |||||
| Title | A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRV-3279 in Healthy Subjects (PREVAIL1) | |||||
| Status | Completed | |||||
| Sponsor | Provention Bio, Inc. | |||||
| NCT05087628 | Click to show the Detail | |||||
| Indication | Systemic Lupus Erythematosus | |||||
| Phase | Phase II | |||||
| Title | PRV-3279-2a Trial in Systemic Lupus | |||||
| Status | Active, not recruiting | |||||
| Sponsor | Provention Bio, a Sanofi Company | |||||