Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 747 |
| INN | Apamistamab-Iodine (131I) |
| Status | Clinical |
| Drug code(s) | I-131-BC8 |
| Brand name | Iomab-B, Iomab-ACT (low dose) |
| mAb sequence source | mAb murine |
| General Molecular Category | Radioimmunotherapy, RIC |
| Format, general category | Full length Ab conjugate |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | I-131 |
| Discovery method/technology | None |
| Target(s) | CD45 |
| Indications of clinical studies | Ablation of bone marrow prior to transplantation |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | July 01, 1993 |
| Start of Phase 2 | |
| Start of Phase 3 | June 29, 2016 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | Actinium Pharmaceuticals |
| Licensee/Partner | Immedica AB |
| Comments about company or candidate | Aug 2024: FDA has now determined that demonstrating an overall survival benefit in a randomized head-to-head trial is required for a BLA filing. https://ir.actiniumpharma.com/press-releases/detail/486/actinium-provides-regulatory-update-on-planned-bla-filing Phase 3 SIERRA data are expected to support the planned Biologics License Application (BLA) submission for Iomab-B to the FDA in 2H:2023, and if approved, the Company intends to commercialize the product in the U.S. Oct. 31, 2022 Actinium Pharmaceuticals, Inc. announced positive top-line results from the pivotal Phase 3 trial for its lead product candidate Iomab-B. Iomab-B met the primary endpoint of durable Complete Remission (dCR) of 6-months following initial complete remission after BMT with high statistical significance (p-value of <0.0001), 22% of patients achieved dCR in the Iomab-B arm compared to 0% in the control arm In April 2022, Actinium licensed the European, Middle East and North African commercial rights for Iomab-B to Immedica AB, a fully-fledged independent pharmaceutical company headquartered in Sweden. June 2021: Phase 3 SIERRA study still recruiting as of last update in April 2021. Plan BLA filing in 2022 (https://d1io3yog0oux5.cloudfront.net/_e303d025a381e01da1fab88f414d14c2/actiniumpharma/db/206/944/pdf/Actinium_InvestorPresentation_June+2021.pdf) March 2020: We expect to complete enrollment of the SIERRA trial and have topline data that we believe will support the submission of a Biologics License Application, or BLA, with the U.S. Food and Drug Administration, or FDA, in 2021. https://seekingalpha.com/filing/5066360 July 23, 2019: Actinium Pharmaceuticals, Inc. announced today that the 75th patient has been treated in the pivotal Phase 3 SIERRA trial of Iomab-B, thus achieving 50 percent patient enrollment for the trial. Preliminary feasibility and safety data from the first twenty-five percent of patients enrolled in the SIERRA trial were presented at several key medical conferences, including at an oral presentation at ASH 2018, in a late breaking oral presentation at TCT 2019, and in a poster at ASCO 2019. NCT02665065 Phase 3 study still recruiting as of Aug 2018. May 10, 2017 -- Actinium Pharmaceuticals, Inc., a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced today that the Company received clearance from Health Canada to initiate the pivotal Phase 3 SIERRA Trial of Iomab-B at Canadian based clinical trial sites. The European Medicines Agency has provided positive guidance for Actinium Pharmaceuticals' Iomab-B for treatment of acute myeloid leukemia. The agency said the company's data from a late-stage study of the drug was sufficient for filing a marketing authorization application. NCT02665065 Phase 3 study start announced June 29 2016. US Orphan designation as a conditioning treatment for patients with relapsed and refractory acute myeloid leukemia who will undergo hematopoietic stem cell transplant. Actinium looks forward to launching a pivotal Phase III trial for Iomab-B in preparing patients for hematopoietic stem cell transplants in 2016. Start of first clinical study is an estimate. Licensed from Fred Hutchinson Cancer Center. Numerous studies of I-131 and Y-90 versions done since 1990s by FHCC. See for example: Development of a marrow transplant regimen for acute leukemia using targeted hematopoietic irradiation delivered by 131I-labeled anti-CD45 antibody, combined with cyclophosphamide and total body irradiation. Matthews DC, Appelbaum FR, Eary JF, Fisher DR, Durack LD, Bush SA, Hui TE, Martin PJ, Mitchell D, Press OW, et al. Blood. 1995 Feb 15;85(4):1122-31. |
| Full address of company | 100 Park Avenue, 23rd Floor, New York, NY 10017 North America United States of America https://www.actiniumpharma.com/contact |
Iomab-B is a radioimmunotherapy comprised of the monoclonal antibody BC8 coupled with the radioisotope Iodine-131 that is designed to deliver targeted payloads to cells that express CD45, a pan-leukemic antigen expressed on white blood cells and stem cells. A nonmyeloablative dose of 131-I apamistamab (75 mCi, Iomab-ACT)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |