CD38-targeted antibody-drug conjugate 
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  • ||||||||||  Journal:  Antibodies and bispecifics for multiple myeloma: effective effector therapy. (Pubmed Central) -  Dec 10, 2022   
    Currently, teclistamab, an anti-BCMA bispecific, is closest to approval for commercial use. In this review, we explore the evolving landscape of antibodies in the treatment of MM, including their role in frontline and relapse settings.
  • ||||||||||  Darzalex (daratumumab) / J&J, Darzalex Faspro (daratumumab/hyaluronidase) / J&J
    Safety of Subcutaneous Daratumumab/ Hyaluronidase after Intravenous Daratumumab for Patients with Multiple Myeloma () -  Nov 29, 2022 - Abstract #ASH2022ASH_8047;    
    Monoclonal antibodies targeting CD38 (i.e., daratumumab and isatuximab) are emerging as mainstay of therapy for upfront as well as relapsed multiple myeloma (MM)...The supportive medication to mitigate the AAR was the same for both preparation (acetaminophen, Diphenhydramine, corticosteroids and montelukast for patients with history of COPD or asthma)...Our results shows no AAR by transitioning from DARA IV to SC if the time interval between the two is less than a year. Therefore, the monitoring times following first dose DARA SC after receiving DARA IV may be able to be shortened in order to increase efficiency in the infusion center and decrease chair time for patients.
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD)
    Phase II Study of Pembrolizumab in Multiple Myeloma Patients Relapsing after or Refractory to Anti-BCMA CAR-T Therapies () -  Nov 29, 2022 - Abstract #ASH2022ASH_7749;    
    P2
    Toxicities of interest include cytokine release syndrome and immune-effector cell-associated neurotoxicity. Exploratory analysis includes assessing the immune profile after pembrolizumab treatment, including changes in absolute lymphocyte count and lymphocyte subsets by flow-cytometry.This ongoing study (NCT05191472) is currently open and enrolling at University of California, San Francisco.
  • ||||||||||  Darzalex (daratumumab) / J&J
    Real-World Outcome of Daratumumab in Patients with Relapsed/Refractory Multiple Myeloma: A Multicenter Propensity Score Matched Case Series Study () -  Nov 29, 2022 - Abstract #ASH2022ASH_7720;    
    Major trials in patients with relapsed/refractory multiple myeloma (RRMM), CASTOR, POLLUX, APOLLO, and CANDOR, has proved benefits in both progression free survival (PFS) and response rate in favor of daratumumab incorporation into proteasome inhibitors (PI) or immunomodulatory agents (IMiDs) and dexamethasone doublet regimen. The median PFS time were 15.2 months in control arm versus unreached in daratumumab arm (p0.05).Conclusion In our real-world propensity score matched data, we confirmed that daratumumab incorporation of MM care could provide significant response and progression free survival benefits.Figure legend: A. Progression free survival and B. overall survival of patients with RRMM receiving daratumumab-based regimens and conventional regimens (control arm).
  • ||||||||||  Darzalex (daratumumab) / J&J
    Evaluation of Daratumumab for the Treatment of Multiple Myeloma in Patients with Renal Insufficiency: A Systematic Review and Meta-Analysis () -  Nov 29, 2022 - Abstract #ASH2022ASH_7686;    
    Similar results were seen for RRMM patients with RI (pooled HR, 0.46; 95% CI, 0.37-0.58; P < .00001).2 studies (Alcyone, Cassiopeia) conducted in NDMM patients had subgroup analysis of MRD- rate in MM with RI, the meta-analysis showed that the addition of Daratumumab to backbone regimens could lead to higher MRD- rate (Risk ratio, 1.72; 95% CI, 1.45-2.06; P<.00001).Meta-analysis conducted among patients with non-RI showed that addition of Daratumumab to standard of care treatment significantly improved the OS (NDMM: pooled HR, 0.64; 95% CI, 0.50-0.82; P =.0005; RRMM: pooled HR, 0.73; 95% CI, 0.60-0.89; P = .001) and PFS (NDMM: pooled HR, 0.57, 95% CI, 0.47-0.69; P<.00001; RRMM: pooled HR, 0.43; 95% CI, 0.37-0.49; P<.00001) in both NDMM and RRMM. And MRD- rate was improved as well (NDMM: Risk ratio, 1.58; 95% CI, 1.36-1.83; P<.00001).Through the test for outcomes of MM patients with RI and non-RI, the result showed that the addition of Daratumumab to the backbone regimens can improve the OS (NDMM: p=0.93; RRMM: p=0.70), PFS (NDMM: p=0.28; RRMM: p=0.55) and MRD- rate (NDMM: p=0.45) of MM patients with RI and non-RI in both NDMM and RRMM to the same extend.Discussion :This study suggests that the addition of Daratumumab to the backbone regimens can lead to longer OS, PFS and achieve higher MRD- rate among patients with RI and non-RI in the context of newly diagnosed and relapsed or refractory disease.
  • ||||||||||  Abecma (idecabtagene vicleucel) / BMS, 2seventy bio
    Rapid Response to Idecabtagene Vicleucel in a Myeloma Patient Refractory to Multiple Prior Lines of Anti-BCMA Directed Therapies () -  Nov 29, 2022 - Abstract #ASH2022ASH_7668;    
    Treatment was switched to isatuximab/pomalidomide/dexamethasone...Lymphodepletion with fludarabine/cyclophosphamide according to the phase-II KarMMa protocol was initiated, and 441.5 x 10exp6 CAR T-cells were infused...Two weeks after infusion of Ide-cel, significant increases of serum uric acid and lactate dehydrogenase levels indicative of tumor lysis syndrome were detected, requiring application of rasburicase and intravenous hydration...This demonstrates that sequential treatment can be effective even after multiple prior lines of anti-BCMA directed therapies. Patients with prior exposure to anti-BCMA agents should have access to anti-BCMA CAR T-cells.
  • ||||||||||  Darzalex (daratumumab) / J&J
    Cytomegalovirus and Epstein-Barr Virus Infection during Daratumumab Treatment in Patients with Multiple Myeloma () -  Nov 29, 2022 - Abstract #ASH2022ASH_7667;    
    In longitudinal analysis of the subpopulations of lymphocytes in PB, we observed NK cell and B cell depletion, and T cell expansion (especially CD8+T cell) after the treatment of Dara. Compared with patients without CMV and/or EBV infections during Dara-containing regimes, patients with CMV and/or EBV infections had significant lower absolute numbers of NK cells, total T cells, CD8+T cells at 1 month and absolute numbers of CD8+T cells at 2 months after the first Dara infusion.Conclusion : We observed a considerable risk of infections of EBV and/or CMV in the early stage of Dara treatment in patients with MM and speculated the potential involvements of NK cells depletion and CD8+T cells expansion in the occurrence of EBV and CMV infections.
  • ||||||||||  Expression of CD38 and Zap-70 Antigens in Chronic Lymphocytic Leukemia () -  Nov 29, 2022 - Abstract #ASH2022ASH_7613;    
    Considering the specific activity of 89Zr-anti-CD38 antibodies of 4.2 MBq/nmol, 89Zr-anti-CD38 antibodies accumulated in RPMI8226 tumors at approximately 730 fmol/mg.Conclusion We proposed a new imaging method, called WGI, which clearly visualized MM cells and was able to estimate the uptake values of 89Zr-anti-CD38 antibody binding to specific antigen in MM tumors. Significant differences were found between CD19+/ZAP-70+ and CD38 cases in patients with CLL-B with laboratory parameters associated with poor prognosis, showing the importance of using these cellular markers as independent prognostic indicators for these leukemias.
  • ||||||||||  Darzalex (daratumumab) / J&J
    Preclinical, Journal:  CD38-specific nanobodies allow in vivo imaging of multiple myeloma under daratumumab therapy. (Pubmed Central) -  Nov 18, 2022   
    Fluorochrome-labeled nanobody JK36 showed specific binding to CD38-expressing myeloma cells pretreated with daratumumab in vitro and ex vivo and allowed for specific imaging of CD38-expressing xenografts in daratumumab-pretreated mice in vivo. Our study demonstrates that a nanobody recognizing a distinct, non-overlapping epitope of CD38 allows the specific detection of myeloma cells under daratumumab therapy in vitro, ex vivo, and in vivo.
  • ||||||||||  Tecvayli (teclistamab) / Genmab, J&J
    Review, Journal:  Teclistamab: First Approval. (Pubmed Central) -  Nov 16, 2022   
    Teclistamab was subsequently approved in the US for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy (including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody). This article summarizes the milestones in the development of teclistamab leading to this first approval for relapsed or refractory multiple myeloma.
  • ||||||||||  Darzalex (daratumumab) / J&J
    Generation Natural Killer Cell-Mimic Nanoparticles for Active Targeting of Acute Myeloid Leukemia (ENMCC - Hall D) -  Nov 4, 2022 - Abstract #ASH2022ASH_6630;    
    Liposomes were synthesized using the thin film hydration method followed by extrusion and functionalized them with the death ligand, TRAIL (tumor necrosis factor-related apoptosis-inducing ligand), immunoglobulin Fc-binding peptide (FCP, replicating the function of NK CD16 receptor) and the therapeutic antibody, anti-CD38 (daratumumab, Panel A) to target acute myeloid leukemia (AML)...Overall, we have developed an NK cell-mimic nanoparticle able to actively target AML based on AML surface marker expression without any detectable systematic toxicity. Importantly, due to the modular built of the NK.NPs, they can be functionalized by any therapeutic tumor-targeting antibody via the immunoglobulin-binding peptide (FCP), thus enabling selective targeting tumor cells based on expression of tumor-specific markers and enabling personalized therapy.
  • ||||||||||  Darzalex (daratumumab) / J&J
    Multi-Antigen Targeting By Novel Combination of CAR-T Cells and hnCD16 Transgene, Yields in Complete Tumor Clearance Via Antibody Dependent Cellular Cytotoxicity (ENMCC - Hall D) -  Nov 4, 2022 - Abstract #ASH2022ASH_6434;    
    For example, the percentage of IFNy+ TNFa+ CAR iT cells increased by approximately 10-fold in a cytokine release assay when hnCD16+ CAR-MICA/B iT cells were combined with anti-CD38 antibody, daratumumab, to target Nalm6 cells...In an orthotopic ovarian tumor model where CAR iT cells demonstrate potent, but incomplete tumor control, in vivo activation of hnCD16 with therapeutic mAb enhanced tumor control and prevented tumor recrudescence. Together, these preliminary results demonstrate that specific arming of an off-the-shelf, allogeneic CAR iT cell product with a unique Fc receptor, hnCD16, enables a flexible and potent anti-tumor killing strategy to mitigate against tumor heterogeneity and to provide more durable and long-lasting responses in cancer patients.
  • ||||||||||  Darzalex (daratumumab) / J&J
    Sumoylation Inhibition Potentiates Daratumumab Activity Against Multiple Myeloma (ENMCC - Hall D) -  Nov 4, 2022 - Abstract #ASH2022ASH_6305;    
    Conclusion Our study proves SUMOylation inhibition potentiates Dara efficacy against multiple myeloma by increasing CD38 level in MM cells and activating immune cells including T, NK cells and monocytes in Type I IFN pathway dependent manner. Our work presents TAK-981 as an efficient combination to Dara therapy in MM treatment, with relevance to other mono antibody therapies for blood cancers and solid tumors.
  • ||||||||||  Arzerra (ofatumumab) / Novartis, Genmab
    Early Treatment with Ofatumumab in Patients with High-Risk CLL (ENMCC - Hall D) -  Nov 4, 2022 - Abstract #ASH2022ASH_6259;    
    The PFS was similar to that of similarly designed trials with rituximab monotherapy and rituximab in combination with alemtuzumab, respectively. Further internal matched analysis is being conducted to compare time to second treatment.
  • ||||||||||  Therapeutic Potential and Role of CD38 in Cutaneous T-Cell Lymphoma Pathogenesis (ENMCC - Hall D) -  Nov 4, 2022 - Abstract #ASH2022ASH_5966;    
    Overall, our studies demonstrate strong evidence for further investigation into the role of CD38 in the immunopathogenesis of CTCL and its value as a novel target for therapeutic intervention. Our data also provide preliminary evidence for the association between CD38 expression and disease progression in CTCL and suggest that the suppressive tumor microenvironment may contribute to disease progression.
  • ||||||||||  Molecular Determinants of Human Red Blood Cell Survival in Murine Circulation (ENMCC - Hall D) -  Nov 4, 2022 - Abstract #ASH2022ASH_3939;    
    These findings warrant evaluating VIP943 in clinical trials. Our data show that CD47 and CD59 expression on human RBCs increases their survival after transfusion, and suggest that pre-transfusion profiling of CD47 and CD59 molecules could help predict the efficiency of human RBC transfusion.
  • ||||||||||  modakafusp alfa (TAK-573) / Takeda
    Final Results from the First-in-Human Phase 1/2 Study of Modakafusp Alfa, an Immune-Targeting Attenuated Cytokine, in Patients (Pts) with Relapsed/Refractory Multiple Myeloma (RRMM) (ENMCC - New Orleans Theater C) -  Nov 4, 2022 - Abstract #ASH2022ASH_3576;    
    P1/2
    As dexamethasone (dex) is part of standard of care in MM, but could counteract the immune activation elicited by modakafusp, additional cohorts at 0.4 mg/kg Q3W and 1.5 mg/kg Q4W in combination with 40 mg dex QW were opened...Conclusions Modakafusp alfa has a novel mechanism of action, a manageable safety profile, and encouraging anti-myeloma activity at 1.5 mg/kg Q4W, independent of peripheral blood immune cell CD38 expression. A randomized phase 2 study to compare fixed-dose levels of 120 and 240 mg (equivalent to 1.5 and 3.0 mg/kg) Q4W and to define the single-agent dose with the optimal benefit/risk profile is currently enrolling.