Product Description
Modakafusp alfa (previously known as TAK-573) is a first-in-class immunocytokine designed to deliver interferon alpha-2b (IFNalpha2b) to CD38+ cells. It consists of two attenuated IFNalpha2b molecules genetically fused to the Fc portion of a humanized, anti-CD38, IgG4 monoclonal antibody (mAb). The specificity for CD38 and reduced IFN receptor binding affinity of the attenuated IFNalpha2b molecules significantly reduces the potential for off-target binding and toxicity. Furthermore, modakafusp alfa binds to a different epitope on CD38 than the currently approved anti-CD38 therapeutic mAbs, daratumumab and isatuximab. Preclinical evaluation of modakafusp alfa supports activation of type I IFN signaling in CD38+ cells, inducing direct anti-proliferative effects on myeloma cells, as well as direct and indirect immune cell activation. (Sourced from: https://www.myeloma.org/videos/modakafusp-alfa-tak-573-immunocytokine-patients-relapsedrefractory-multiple-myeloma-updated)
Mechanisms of Action: CD38 Inhibitor
Novel Mechanism: No
Modality: Fusion Protein
Route of Administration: Intravenous
FDA Designation: None *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Takeda
Company Location: TOKYO M0 103-8668
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Belgium, Canada, China, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Japan, Korea, Norway, Puerto Rico, South Korea, Spain, Taiwan, Turkey, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 8
Highest Development Phases
Phase 2: Multiple Myeloma
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| A Safety and Preliminary Efficacy, Pharmacokinetics, and Immunogenicity Study | P2 |
Active, not recruiting |
Multiple Myeloma |
2030-04-11 |
|
| 2022-001418-20 | P2 |
Active, not recruiting |
Multiple Myeloma |
2028-02-13 |
|
| 2022-002169-14 | P2 |
Active, not recruiting |
Multiple Myeloma |
2025-04-23 |
|
| jRCT2061220078 | P2 |
Recruiting |
Multiple Myeloma |
2024-09-03 |