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Also known as Vonsetamig, Noninterventional, BCMAxCD3
REGN5459 · 3 trials · 4 indications
TEAEs include adverse events of special interest (AESI) and serious adverse events (SAEs)
Phase 1
Phase 1
Phase 1
Phase 2
| Arm | Type | Description |
|---|---|---|
| Experimental Arm 1: Vonsetamig | EXPERIMENTAL | - |
| Experimental Arm 2: Odronextamab | EXPERIMENTAL | - |
| Vonsetamig | EXPERIMENTAL | - |
| REGN5459 | EXPERIMENTAL | Cohorts of multiple REGN5459 dose levels |
| Name | Type | Description |
|---|---|---|
| Vonsetamig | DRUG | Administered as per the protocol |
| Odronextamab | DRUG | Administered as per the protocol |
| REGN5459 | DRUG | Administered by intravenous (IV) infusion |
Key General Inclusion Criteria: 1. Diagnosis of Systemic Lupus Erythematosus (SLE) and LN, as described in the protocol 2. Participant must have refractory or relapsed disease, as described in the protocol Key General Exclusion Criteria: 1. History of or active severe or unstable lupus-associated...
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REGN5459 is an investigational small molecule being developed by Regeneron Pharmaceuticals for relapsed or refractory multiple myeloma, a cancer of plasma cells in the bone marrow. It is a Phase 1 clinical-stage asset and has not been approved by the FDA. It was studied in a single first-in-human trial that has completed.
REGN5459 is being studied for the treatment of relapsed or refractory multiple myeloma in adults. The clinical program enrolled patients 18 years and older with relapsed or refractory disease. It remains investigational, and no approved use has been established for REGN5459 in multiple myeloma or any other indication.
REGN5459 targets BCMA, or B-cell maturation antigen, a protein expressed on the surface of plasma cells. BCMA is a recognized target in multiple myeloma because it is highly expressed on malignant plasma cells. REGN5459 is described as a small molecule directed against this protein target.
Regeneron Pharmaceuticals, Inc. is developing REGN5459. Regeneron trades on the Nasdaq under the ticker REGN. The company sponsored the first-in-human Phase 1 study of REGN5459 in adult patients with relapsed or refractory multiple myeloma, which was conducted in the United States.
REGN5459 is in Phase 1 development. Its only listed clinical trial, a first-in-human study in relapsed or refractory multiple myeloma, has completed. The program enrolled 43 patients. REGN5459 is investigational and has not received FDA approval for any indication.
REGN5459 has been evaluated in one clinical trial, NCT04083534, titled a First In Human Study of REGN5459 in Adult Patients With Relapsed or Refractory Multiple Myeloma. That Phase 1 trial is completed, enrolled 43 participants, was conducted in the United States, and was an uncontrolled study without randomization or blinding.