zinpentraxin alfa (RG6354) / Roche 
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  • ||||||||||  zinpentraxin alfa (RG6354) / Roche
    Zinpentraxin Alfa in Patients With Idiopathic Pulmonary Fibrosis: Results and Learnings From the Phase III STARSCAPE Trial (San Diego Convention Center, Ballroom 20A (Upper Level)) -  Feb 20, 2024 - Abstract #ATS2024ATS_7128;    
    P3
    The different efficacy outcome in Phase II versus III could be explained by outliers in FVC decline occurring in placebo patients in Phase II, which impacted the calculated mean values and consequently the comparison of zinpentraxin alfa versus placebo. Understanding how outliers should be analyzed and what learnings can be taken forward is crucial to inform future IPF trials.
  • ||||||||||  zinpentraxin alfa (RG6354) / Roche
    Journal:  Repeat-Dose and Embryo-Fetal Developmental Toxicity of Zinpentraxin Alfa. (Pubmed Central) -  Jan 22, 2024   
    The disparate effects of zinpentraxin alfa on embryo-fetal development between the two species suggests a potential unknown biological function of PTX-2 in pregnancy in the rabbit, which may be relevant to humans. Our findings warrant the consideration for highly effective contraceptive measures to avoid pregnancy in patients enrolled in clinical studies with zinpentraxin alfa.
  • ||||||||||  zinpentraxin alfa (RG6354) / Roche
    Journal:  Evaluation of multiple immunoassay formats for detection of anti-drug antibodies to zinpentraxin alfa. (Pubmed Central) -  Oct 30, 2023   
    Overall, the semi-homogenous ADA assay format with no sample pre-treatment was selected for the measurement of zinpentraxin alpha immunogenicity as it provided the desired sensitivity, drug tolerance, and reproducibility. Our study emphasizes the importance of assay format evaluation during drug development and the necessity to select the most suitable assay format and sample pre-treatment method by which to evaluate therapeutic drug immunogenicity.
  • ||||||||||  Ebglyss (lebrikizumab) / Roche, Almirall, Eli Lilly, Actemra IV (tocilizumab) / Roche, JW Pharma, zinpentraxin alfa (RG6354) / Roche
    Journal:  Weak to no correlation between quantitative high-resolution computed tomography metrics and lung function change in fibrotic diseases. (Pubmed Central) -  Oct 24, 2023   
    The incremental prognostic value of the baseline HRCT metrics was marginal after adjusting baseline characteristics and was inconsistent across study arms. Data from the SSc and IPF studies suggested weak to no and inconsistent correlation between quantitative HRCT metrics derived by the Imbio LTA tool and FVC slope in the studied SSc and IPF population.
  • ||||||||||  Review, Journal:  Anemia in myelofibrosis: current and emerging treatment options. (Pubmed Central) -  Nov 5, 2022   
    This review summarizes current and emerging treatments for anemia in MF, including luspatercept and KER-050 (transforming growth factor-β ligand traps), momelotinib and pacritinib (JAK inhibitors), pelabresib (a bromodomain extra-terminal domain inhibitor), PRM-151 (an antifibrotic agent), imetelstat (a telomerase inhibitor), and navitoclax (a BCL-2/BCL-xL inhibitor). Therapeutic combinations with ruxolitinib may offer another treatment approach.
  • ||||||||||  lademirsen (RG-012) / Regulus Therapeutics, Sanofi, recombinant human pentraxin-2 (RG6354) / Roche, Kerendia (finerenone) / Bayer
    Review, Journal:  Antifibrotic Agents for the Management of CKD: A Review. (Pubmed Central) -  Jul 28, 2022   
    Reversing dysfunctional tubular cell metabolism that leads to kidney fibrosis offers additional therapeutic opportunities. However, any future drug targeting fibrosis of the kidneys should demonstrate added benefit to a novel standard of care combining renin-angiotensin system with mineralocorticoid receptor (e.g. finerenone) blockade or with SGLT2 inhibitors.
  • ||||||||||  Review, Journal:  Novel treatments for myelofibrosis: beyond JAK inhibitors. (Pubmed Central) -  Apr 30, 2022   
    Specifically, we discuss agents that target epigenetic modification (pelabresib, bomedemstat), apoptosis (navitoclax, navtemdalin), signaling pathways (parsaclisib), bone marrow fibrosis (AVID200, PRM-151), in addition to other targets including telomerase (imetelstat), selective inhibitor of nuclear transport (selinexor), CD123 (tagraxofusp) and erythroid maturation (luspatercept). We end by providing commentary on the ongoing and future therapeutic development in myelofibrosis.
  • ||||||||||  Empliciti (elotuzumab) / AbbVie, BMS
    A Pilot Study of the Anti-SLAMF7 Monoclonal Antibody, Elotuzumab, in Myelofibrosis (GWCC - Hall B5, Level 1) -  Nov 5, 2021 - Abstract #ASH2021ASH_5326;    
    P2
    These findings led to the clinical development of PRM-151 (recombinant human pentraxin-2) as an anti-fibrotic agent for patients with myelofibrosis (MF) (Verstovsek, EHA 2019)...Finally, elotuzumab, a SLAMF7-targeting monoclonal antibody, inhibited the differentiation of MF patient-derived fibrocytes in vitro and romiplostim-induced MF and splenomegaly in vivo...Elotuzumab is dosed intravenously weekly at 10 mg/kg per dose for the first 8 doses, followed by 20 mg/kg every 4 weeks, per the label for its use in multiple myeloma in combination with pomalidomide and dexamethasone...Current status: The study (clinicaltrials.gov identifier: NCT04517851) is ongoing; 2 participants have been enrolled and treated thus far. Updated enrollment information will be provided.
  • ||||||||||  Journal:  Investigational non-JAK inhibitors for chronic phase myelofibrosis. (Pubmed Central) -  Jan 21, 2021   
    Drugs that target new molecular pathways (MDM2, p-selectin, TIM-3, Bcl-2, TGF-β, aurora kinase) and immune-based strategies (CALR vaccine, anti-PD-1, allogeneic cord blood regulatory T cells) are in early phase trials. Further translational studies to target leukemic stem cells, improvement in trial designs by incorporating control arm and survival endpoints, and patient-focused collaborations among all stakeholders could pave a way for future success in MF drug development.
  • ||||||||||  Clinical, Review, Journal:  Novel Concepts of Treatment for Patients with Myelofibrosis and Related Neoplasms. (Pubmed Central) -  Oct 21, 2020   
    Janus kinase (JAK) inhibition forms the cornerstone of the treatment of myelofibrosis (MF), and the JAK inhibitor ruxolitinib is often used as a second-line agent in patients with polycythemia vera (PV) who fail hydroxyurea (HU)...JAK inhibitor-based combinations, all of which are currently under study for MF, have been covered elsewhere in this issue. In this article, we focus on agents that have been studied as monotherapy in patients with MF, generally after JAK inhibitor resistance/intolerance, as well as several novel compounds in development for PV/ET.
  • ||||||||||  recombinant human pentraxin-2 (RG6354) / Roche
    Trial primary completion date:  A Phase 2 Study of RO7490677 In Participants With Myelofibrosis (clinicaltrials.gov) -  Sep 11, 2020   
    P2,  N=98, Completed, 
    In this article, we focus on agents that have been studied as monotherapy in patients with MF, generally after JAK inhibitor resistance/intolerance, as well as several novel compounds in development for PV/ET. Trial primary completion date: Aug 2017 --> Jul 2020
  • ||||||||||  recombinant human pentraxin-2 (RG6354) / Roche
    Trial completion, Trial completion date:  A Phase 2 Study of RO7490677 In Participants With Myelofibrosis (clinicaltrials.gov) -  Aug 27, 2020   
    P2,  N=98, Completed, 
    Trial primary completion date: Aug 2017 --> Jul 2020 Active, not recruiting --> Completed | Trial completion date: Jan 2020 --> Jul 2020
  • ||||||||||  [VIRTUAL] New Therapies in Development for Myelofibrosis () -  Jul 14, 2020 - Abstract #SOHO2020SOHO_149;    
    P1/2, P1b,
    Ruxolitinib blocks excessive proliferation of hematopoietic stem cells and pro-inflammatory cytokine production, which leads to improvement in quality-of-life and spleen volume, thus prolonging survival in MF patients.2 In late 2019, another oral JAK2 inhibitor, fedratinib, was approved for intermediate-2 and high-risk MF...Interim data from the trial demonstrated reduction in spleen volume, BM fibrosis, anemia and blood transfusions, as well as total symptom score improvement in MF patients who were JAK-inhibitor naive7 or had a suboptimal response to ruxolitinib.8 Notably, preclinical studies manifested synergistic lethal activity of combined HSP90 (a chaperone of JAK2) and BET inhibitors in ruxolitinib-resistant post-MPN AML cells,6 and combination treatment of MPN cells with the HSP90 inhibitor PU-H71 and ruxolitinib synergistically reduced p-JAK2 and inhibited the JAK/STAT pathway.9 On the basis of the aforementioned preclinical findings, a phase 1b study that is assessing the safety and efficacy of PU-H71 in ruxolitinib-treated patients with primary or secondary MF (NCT03935555) is underway...Hematological responses, reduction in spleen volume, and improvement of symptoms were noted, and PRM-151 was very well tolerated.11 Bcl-2/Bcl-xL inhibition Navitoclax is an orally bioavailable inhibitor of the anti-apoptotic Bcl-2 family of proteins (primarily Bcl-xL)...Conclusions Besides the agents highlighted herein, spanning new JAK inhibitors (momelotinib, pacritinib), epigenetic modifiers (CPI-0610), and inhibitors of telomerase (imetelstat), HSP90, and HDM2, other investigational drugs, such as LCL161, parsaclisib, and KRT-232 are currently evaluated in clinical trials (Table 1). After many years with ruxolitinib as the sole drug to treat MF, it is exciting to witness many promising novel drugs, based on various biological mechanisms, enter early and late phase clinical trials and usher the way to a new era in treatment of MF.
  • ||||||||||  Jakafi oral (ruxolitinib) / Novartis, Incyte, azacitidine / Generic mfg.
    Clinical, Review, Journal:  New Concepts of Treatment for Patients with Myelofibrosis. (Pubmed Central) -  Mar 26, 2020   
    Pacritinib, a non-myelosuppressive JAK2-selective inhibitor, is currently in a dose-ranging study mandated by regulatory authorities...Emerging data supports the addition of azacitidine to ruxolitinib in some patients...This is important, because cytopenias are the commonest reason for ruxolitinib interruption and/or dose reduction, and dose optimization of ruxolitinib is tied to its survival benefit. The activin receptor ligand trap, sotatercept, and the anti-fibrotic agent, PRM-151, have shown promise in this regard.