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  • ||||||||||  Actimab-A (lintuzumab-Ac225) / Actinium
    Lintuzumab-Ac225 has potent mutation agnostic antileukemic activity in preclinical models of AML (Section 25; Poster Board No: 29) -  Mar 25, 2025 - Abstract #AACR2025AACR_3134;    
    It improves AML control in high-risk cases and enhances response durability when combined with standard of care treatments. These findings support its potential as a backbone therapy for relapsed/refractory AML, warranting further clinical evaluation.
  • ||||||||||  Actimab-A (lintuzumab-Ac225) / Actinium
    Lintuzumab-Ac225 Exerts Mutation Agnostic Antileukemic Activity in Preclinical Models of AML () -  Dec 7, 2024 - Abstract #ASH2024ASH_7881;    
    In clinical trials, lintuzumab-Ac225 has demonstrated promising therapeutic responses when added to CLAG-M chemotherapy in heavily pretreated relapsed/refractory AML patients, including high risk populations with venetoclax failures and TP53 mutations...Although the single agent cytotoxicity of FLT3 inhibitors (gilteritinib, quizartinib) and KMT2A inhibitors (revumenib, ziftomenib) was observed with varied sensitivity in both MV-4-11 and MOLM-13 FLT3/KMT2A mutation-carrying cells, the combinations with lintuzumab-Ac225 were additive at all studied dose levels (p<0.01)...CD33-targeted radiation-induced damage improves AML control in adverse-risk settings, and further potentiates response durability when added to standard-of-care, including molecularly targeted therapy. Collectively, these data support the backbone therapy potential of lintuzumab-Ac225 in a mutation agnostic manner, warranting further clinical evaluation in difficult to treat relapsed/refractory AML.
  • ||||||||||  Iomab-B (I-131-apamistamab) / Actinium, Immedica
    Humanization of Clinically Used Murine CD45 Antibody for Optimized CD45-Targeted Radioimmunotherapy (Halls G-H (San Diego Convention Center)) -  Nov 6, 2024 - Abstract #ASH2024ASH_4367;    
    Validating this approach, BC8 labeled with iodine-131 (131I-apamistamab [Iomab-B]) followed by allogeneic HCT was recently shown to improve outcomes of older adults with relapsed/refractory AML relative to conventional care...Our studies identify the antibody framework (with greatest efficacy so far observed with IgG1) and specific activity as critical factors for the efficacy of 211At-NCS-HuBC8. Together, these study support further development of HuBC8 as antibody for possible clinical RIT applications.
  • ||||||||||  Iomab-B (I-131-apamistamab) / Actinium, Immedica
    Modeling-based Assessment of Exposure Measurements After High-Dose Targeted 131I-apamistamab: Results and Analyses from the Phase III SIERRA Trial (Hall Y4-Y9) -  Sep 27, 2024 - Abstract #EANM2024EANM_568;    
    Exposure readings following radiation isolation showed considerable variability in clearance rate between patients, although no difference was seen in estimated time needed to reach release criteria by administered activity level, with a median of only 5 days even for patients receiving activities over 800 mCi. This ensured that patients were well below the 131I release criteria at the time of transplant, typically 12 days following the 131I-apamistamab infusion.
  • ||||||||||  Iomab-B (I-131-apamistamab) / Actinium, Immedica
    Long-Term Follow-up Demonstrates Ongoing Efficacy Benefit of (LEVEL 3, HALL B3) -  Aug 30, 2024 - Abstract #SOHO2024SOHO_440;    
    P3
    Most patients achieving dCR are long-term survivors. Improved outcomes in Iomab-B-treated patients persisted at longer follow-up.
  • ||||||||||  Actimab-A (lintuzumab-Ac225) / Actinium
    ANTILEUKEMIC ACTIVITY OF CD33-DIRECTED MUTATION-AGNOSTIC LINTUZUMAB-AC225 IN KMT2A MUTANT AML (Poster Area (Hall 7)) -  May 15, 2024 - Abstract #EHA2024EHA_939;    
    Combination of CD33-targeted radionuclide therapy with menin inhibitorsignificantly improves AML control, demonstrating that targeted radiotherapy approaches can augment menin-targeted therapy. Based on these findings, the combination of lintuzumab-Ac225 with mutation-targetedagents may enhance anti-leukemic response compared to single-agent approaches.
  • ||||||||||  Actimab-A (lintuzumab-Ac225) / Actinium
    Safety and Dosimetric Analysis of Lintuzumab-Ac225 in Combination with Intensive CLAG-M Chemotherapy in Patients with Relapsed/Refractory AML (717AB (Convention Center); In-Person) -  May 8, 2024 - Abstract #SNMMI2024SNMMI_1758;    
    Induction consisted of G-CSF, 300mcg/d, given D1-6, cladribine 5mg/m2, given D2-6, cytarabine2g/m2, given D2-6, and mitoxantrone 10mg/m2, given D2-4. Lintuzumab-Ac225 can be delivered with estimated radiation doses well below expected tolerance thresholds from EBRT, which was validated by the safety results of this study showing no toxicity to potential dose-limiting organs (liver, lungs, kidneys, heart, intestine) at studied dose levels of Lintuzumab-Ac225.
  • ||||||||||  Iomab-B (I-131-apamistamab) / Actinium, Immedica
    131I-Apamistamab Improves Outcomes in Patients 65 Years and Older with Relapsed or Refractory AML (Stars at Night B2 & B3 (Ballroom Level, Henry B. Gonzalez Convention Center); in-person) -  Dec 5, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_720;    
    P3
    Both PIF and TP53 for Iomab B pts were double in frequency compared to the CC patients. Iomab-B was effective in improving outcomes despite advancing age and presence of these very high-risk features.
  • ||||||||||  Iomab-B (I-131-apamistamab) / Actinium, Immedica
    131I-Apamistamab Effectively Achieved Durable Responses in Patients with R/R AML Irrespective of the Presence of Multiple High-Risk Factors (SDCC - Halls G-H) -  Nov 3, 2023 - Abstract #ASH2023ASH_2597;    
    P3
    Pts with R/R AML who have multiple risk factors such as adverse risk cytogenetics, age >65, venetoclax failure, high comorbidity index or poor KPS are typically not considered for alloHCT due to high transplant-related mortality and post-transplant relapse rates. 131 I-apamistamab was effective in achieving durable responses in R/R AML pts irrespective of the presence of multiple risk factors and successfully enabled alloHCT in such pts due to its targeted mechanism of action.
  • ||||||||||  Actimab-A (lintuzumab-Ac225) / Actinium
    Preclinical evaluation of lintuzumab-Ac225, a CD33 antibody radioconjugate targeting myeloid-derived suppressor cells (Exhibit Hall B) -  Sep 27, 2023 - Abstract #SITC2023SITC_1468;    
    Conclusions In this study, we demonstrated lintuzumab-Ac225 radiotherapy can deplete human CD33 positive immune suppressing MDSCs and through PET imaging illustrated the intra-tumoral targeting capabilities of alpha-emitting radiotherapy. Continued evaluation of lintuzumab-Ac225 as an MDSC targeting agent is highly warranted, including the potential to combine with immune checkpoint therapy, to further enhance antitumor immunity in cancer patients.
  • ||||||||||  Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Xospata (gilteritinib) / Astellas, Actimab-A (lintuzumab-Ac225) / Actinium
    Antileukemic Activity of Lintuzumab?Ac225 in Preclinical Model of FLT3 Mutant AML () -  Aug 31, 2023 - Abstract #SOHO2023SOHO_441;    
    Our findings show that single-agent lintuzumab-Ac225 has potent antileukemic activity against FLT3 mutant AML and can significantly improve the effect of FLT3 inhibitors in combination. Based on these results, lintuzumab-Ac225 may potentially provide new combination therapy for patients with FLT3 mutant AML.
  • ||||||||||  Iomab-B (I-131-apamistamab) / Actinium, Immedica
    Journal:  Nelson Bay Reovirus Isolated from Bats and Blood-Sucking Arthropods Collected in Yunnan Province, China. (Pubmed Central) -  Aug 21, 2023   
    This study successfully isolated two NBV strains (MLBC1302 and MLBC1313) from blood-sucking bat fly specimens (Eucampsipoda sundaica) and one (WDBP1716) from the spleen specimen of a fruit bat (Rousettus leschenaultii), which were collected at the China-Myanmar border area of Yunnan Province...While the potential threat to humans remains to be determined, evolutionary analyses involving different segments revealed that the novel strains had complex reassortment histories, with S1, S2, and M1 segments highly similar to human pathogens. Further experiments are required to determine whether more NBVs are vectored by bat flies, their potential threat to humans, and transmission dynamics.
  • ||||||||||  Actimab-A (lintuzumab-Ac225) / Actinium
    Trial completion date, Trial primary completion date:  Venetoclax and Lintuzumab-Ac225 in AML Patients (clinicaltrials.gov) -  Aug 4, 2023   
    P1/2,  N=38, Recruiting, 
    Further experiments are required to determine whether more NBVs are vectored by bat flies, their potential threat to humans, and transmission dynamics. Trial completion date: Jan 2023 --> Jun 2024 | Trial primary completion date: Dec 2022 --> Nov 2023
  • ||||||||||  Actimab-A (lintuzumab-Ac225) / Actinium
    Enrollment change, Trial withdrawal:  Venetoclax, Azacitidine, and Lintuzumab-Ac225 in AML Patients (clinicaltrials.gov) -  Jul 20, 2023   
    P1/2,  N=0, Withdrawn, 
    Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2024 --> Jan 2025 N=38 --> 0 | Not yet recruiting --> Withdrawn