I-131-Apamistamab - Actinium Pharmaceuticals
Alternative Names: 131-I-labeled anti-CD45 antibody; 131-I-labeled BC8 antibody; 131I-BC8 (anti-CD45) antibody - Actinium Pharmaceuticals; Anti-CD45 monoclonal antibody-BC8-I-131; Anti-CD45 monoclonal antibody-I-131; BC 8; BC8-I-131 construct; I-131-BC8; I131-Apamistamab; Iodine I 131 Apamistamab; Iodine-131-apamistamab; Iomab-ACT; Iomab-BLatest Information Update: 07 Aug 2024
At a glance
- Originator Fred Hutchinson Cancer Research Center
- Developer Actinium Pharmaceuticals; Fred Hutchinson Cancer Research Center; Memorial Sloan-Kettering Cancer Center
- Class Antineoplastics; Immunoconjugates; Iodine radioisotopes; Monoclonal antibodies; Radiopharmaceuticals
- Mechanism of Action Ionising radiation emitters
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Phase III Acute myeloid leukaemia
- Phase II Myelodysplastic syndromes; Precursor cell lymphoblastic leukaemia-lymphoma
- No development reported Diffuse large B cell lymphoma; Hodgkin's disease; Non-Hodgkin's lymphoma; Precursor B-cell lymphoblastic leukaemia-lymphoma
Most Recent Events
- 05 Aug 2024 Actinium plans to request a meeting with the US FDA to further discuss specifics of additional trial
- 05 Aug 2024 the US FDA determines that the Phase III SIERRA trial is not adequate to support a BLA filing for Iomab-B and asks for additional investigations
- 01 Aug 2024 Actinum Pharmaceuticals has patent protection for composition of matter patents covering Iomab-ACT in the US, until 2040