CCR/CCR modulator 

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  • ||||||||||  cenicriviroc (TBR-652) / Takeda, AbbVie, Ocaliva (obeticholic acid) / Intercept, pioglitazone / Generic mfg.
    Journal, Gene Signature:  Fibrogenic Gene Signature as Early Prediction for the Efficacy of Pharmacological Interventions for MASH-Associated Fibrosis. (Pubmed Central) -  Jun 14, 2025   
    This study highlights the potential of using short-term studies and applying a fibrogenic gene signature as an early screening tool to investigate the efficacy of investigative drugs on MASH-associated fibrosis. This signature, which is based on the active fibrosis processes in humans, may allow rapid screening of therapeutics, or combinations thereof, when used in a translational mouse model.
  • ||||||||||  Selzentry (maraviroc) / ViiV Healthcare
    Journal:  CCR5-mediated dynamic maintenance of resident memory T cells in the respiratory tract. (Pubmed Central) -  Jun 3, 2025   
    Temporary CCR5 blockade by intratracheal administration of Maraviroc, a CCR5 inhibitor, reduced the abundance of dLN TRM cells without affecting lung TRM cells...Finally, dLN TRM cells actively participated in the secondary response and could reconstitute lung TRM cells following influenza infection. Our results support a model in which lung-to-dLN TRM retrograde migration helps maintain the CD8+ memory resident in the respiratory tract and optimizes the local T-cell response to reinfection.
  • ||||||||||  Selzentry (maraviroc) / ViiV Healthcare, cenicriviroc (TBR-652) / Takeda, AbbVie
    Journal:  Understanding residual risk of cardiovascular disease in people with HIV. (Pubmed Central) -  May 21, 2025   
    inhibitors, CCR5 antagonists (e.g., maraviroc, cenicriviroc mesylate), and immunomodulatory agents like methotrexate and colchicine, are being explored. Understanding HIV-driven immune dysregulation may lead to novel strategies to mitigate cardiovascular risk in this population.
  • ||||||||||  Journal:  LEADS - a comprehensive human liver-on-a-chip for non-alcoholic steatohepatitis (NASH) drug testing. (Pubmed Central) -  May 20, 2025   
    Notably, treatment with saroglitazar, pioglitazone, cenicriviroc (CVC), obeticholic acid (OCA) and resmetirom produced responses similar to those observed in clinical trials. Taken together, our LEADS model is the first model developed using patient-derived hepatic stem cells which recapitulated all key features used for comprehensive drug testing, with results matching to clinical responses.
  • ||||||||||  Vyrologix (leronlimab) / CytoDyn, Vyera Pharma, amfAR
    Clinical, Journal:  Leronlimab Treatment for Multidrug-Resistant HIV-1 (OPTIMIZE): a Randomized, Double-Blind, Placebo-Controlled Trial. (Pubmed Central) -  May 13, 2025   
    Leronlimab resulted in significantly reduced plasma HIV-1 within 1 week after addition to failing antiretroviral therapy. After 24 weeks combined with an optimized background treatment, most participants had plasma HIV-1 RNA levels <50 copies per milliliter plasma, suggesting utility of leronlimab as a component of salvage therapy.
  • ||||||||||  Vyrologix (leronlimab) / CytoDyn, Vyera Pharma, amfAR
    Enrollment open, Trial initiation date:  A Phase 2 Study of Leronlimab in Combination With TAS-102 + Bevacizumab in Previously Treated Participants With mCRC (clinicaltrials.gov) -  May 12, 2025   
    P2,  N=60, Recruiting, 
    After 24 weeks combined with an optimized background treatment, most participants had plasma HIV-1 RNA levels <50 copies per milliliter plasma, suggesting utility of leronlimab as a component of salvage therapy. Not yet recruiting --> Recruiting | Initiation date: Feb 2025 --> May 2025
  • ||||||||||  Sunlenca (lenacapavir) / Gilead
    Capsid Inhibition with Lenacapavir in HIV-1 Infection: Real-life Results from the French Compassionate Use Program () -  May 10, 2025 - Abstract #IASHIV2025IAS_HIV_1701;    
    OBR included mainly darunavir/r (n=13), dolutegravir (n=11), cabotegravir (n=10), fostemsavir (n=12), maraviroc (n=8), ibalizumab (n=7) and enfuvirtide (n=4). In this real-life cohort of highly treatment-experienced HIV-1 participants, lenacapavir in combination with an OBR resulted in a high level of virological suppression up to 26 weeks, even increasing throughout the end of follow-up.
  • ||||||||||  Selzentry (maraviroc) / ViiV Healthcare
    Journal:  Traffic control: Mechanisms of ligand-specific internalization and intracellular distribution of CCR5. (Pubmed Central) -  May 1, 2025   
    A CCR5 inhibitor Maraviroc has been approved for blocking HIV entry; however, inhibitors for the treatment of other diseases have had limited success, likely because of the complexity of CCR5 pharmacology and biology...It responds to different ligands with distinct signaling and trafficking behaviors; notably, some ligands induce retention of the receptor inside the cell. This study reveals the cellular basis for receptor sequestration that can be exploited as a therapeutic strategy for inhibiting CCR5 function.
  • ||||||||||  BAY86-5047 / Bayer
    Journal:  CCR1 inhibition sensitizes multiple myeloma cells to glucocorticoid therapy. (Pubmed Central) -  Apr 29, 2025   
    Our findings suggest that CCR1 may play a role in glucocorticoid resistance, as the GC-induced downregulation of CCR1 mRNA and protein is blunted in a GC-resistance onset model. Moreover, we demonstrate that inhibiting CCR1 partially reverses this resistance, providing a promising strategy for resensitizing MM cells to GC treatment.
  • ||||||||||  Vyrologix (leronlimab) / CytoDyn, Vyera Pharma, amfAR
    Enhancing Transplacental Delivery of Monoclonal Antibodies Through FcRn Optimization (Exhibit Hall, Hawaii Convention Center; Board Number 2053) -  Apr 26, 2025 - Abstract #IMMUNOLOGY2025IMMUNOLOGY_2728;    
    A single dose of leronlimab-PLS also ensured complete CCR5 receptor occupancy in mothers and newborns for nearly a month postpartum. These findings demonstrate that optimizing FcRn interactions can enhance transplacental mAb delivery and extend therapeutic efficacy, offering a novel approach to protect vulnerable populations during pregnancy and early life.
  • ||||||||||  Libtayo (cemiplimab-rwlc) / Regeneron
    Neoadjuvant immunotherapy of hepatocellular carcinoma: A single-institution experience at Mount Sinai. () -  Apr 23, 2025 - Abstract #ASCO2025ASCO_5134;    
    P2
    Neoadjuvant immunotherapy with anti-PD-1 in patients with resectable HCC appears to be feasible with a generally acceptable safety profile. Further studies are needed to identify optimal immunotherapy regimens to be used in the neoadjuvant setting as well as optimal duration, and larger cohorts are needed to validate the correlation of pathological response with recurrence and survival.
  • ||||||||||  Anniko (penpulimab) / Akesobio, Sino Biopharm
    Enrollment open:  Clinical Studies for the Treatment of Advanced Solid Tumors (clinicaltrials.gov) -  Apr 18, 2025   
    P1/2,  N=134, Recruiting, 
    ICP-B05 is safe and well tolerated and its safety profile made it a good candidate for combo therapies for CTCL patients with lymph node and other organ involvement. Not yet recruiting --> Recruiting
  • ||||||||||  Vyrologix (leronlimab) / CytoDyn, Vyera Pharma, amfAR
    Engineering an Endoplasmic Reticulum (ER) Stress Responsive RNA Structural Switch for mRNA and Gene Therapies (Room 288-290) -  Apr 10, 2025 - Abstract #ASGCT2025ASGCT_2045;    
    Then, we replaced reporter genes with therapeutically relevant ER stress causing FVIII and Leronlimab (an anti-CCR5 monoclonal antibody being evaluated for HIV treatment)...Further testing and refinement of XBP1F modified therapeutic constructs in animal models with the goal of developing mRNA and gene therapies with decreased immunotoxicity and improved safety profiles is underway. Disease Focus of Abstract:None
  • ||||||||||  5P12-RANTES / Orion Biotech
    Phase classification, Enrollment change, Trial withdrawal, Monotherapy:  Study of OB-002 in Patients With Refractory Metastatic Cancer (clinicaltrials.gov) -  Apr 8, 2025   
    P1,  N=0, Withdrawn, 
    Disease Focus of Abstract:None Phase classification: P1b --> P1 | N=36 --> 0 | Not yet recruiting --> Withdrawn
  • ||||||||||  CAP-100 / Catapult Therap
    Trial completion date, Trial primary completion date, Monotherapy:  CAP-100 for Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia (clinicaltrials.gov) -  Apr 7, 2025   
    P1,  N=18, Recruiting, 
    Phase classification: P1b --> P1 | N=36 --> 0 | Not yet recruiting --> Withdrawn Trial completion date: Apr 2025 --> Apr 2027 | Trial primary completion date: Jan 2025 --> Jan 2027
  • ||||||||||  Selzentry (maraviroc) / ViiV Healthcare
    Preclinical, Journal:  Oligodendroglial precursor cells modulate immune response and early demyelination in a murine model of multiple sclerosis. (Pubmed Central) -  Apr 2, 2025   
    Antagonizing chemokine receptor 5 (CCR5) using a European Medicines Agency-approved drug, maraviroc, reduced immune cell infiltration, alleviated demyelination, and attenuated EAE progression. We found an OPC-orchestrated immune cellular network that instigates early demyelination, provides insight into MS pathophysiology, and suggests avenues for early interventions.
  • ||||||||||  Selzentry (maraviroc) / ViiV Healthcare, Invokana (canagliflozin) / J&J, Daiichi Sankyo, Mitsubishi Tanabe
    Journal:  Investigating drug-liposome interactions using liposomal electrokinetic chromatography. (Pubmed Central) -  Apr 1, 2025   
    Mobility of positively charged substances, ambroxol and maraviroc, was suppressed by the interactions with liposomes...However, the effects were complex due to changes in API ionization and liposome surface charge, complicating the distinction between pH effects and liposome presence on API behavior. Our findings emphasize the significance of liposome composition, temperature, and pH in studying the interactions of liposomes with drugs, which is crucial for optimizing liposome-based drug delivery systems.
  • ||||||||||  Selzentry (maraviroc) / ViiV Healthcare
    Review, Journal:  Treatments for Long COVID autonomic dysfunction: a scoping review. (Pubmed Central) -  Mar 27, 2025   
    Guidelines display some overlap, and we identified no direct contradictions. Unpublished/ongoing studies may shed light on this critical area of patient management.
  • ||||||||||  DT-7012 / Domain Therap
    Comprehensive characterization of DT-7012, a differentiated CCR8-depleting antibody for the treatment of solid tumors (Section 15; Poster Board No: 4) -  Mar 25, 2025 - Abstract #AACR2025AACR_2939;    
    DT-7012 exhibits high-affinity binding to CCR8, potent Fc-mediated effector functions, and selective depletion of CCR8+ Tregs in NSCLC patient samples as well as a good safety profile. These findings highlight the therapeutic potential of DT-7012 as a novel strategy to enhance anti-tumor immunity and support its upcoming clinical development.
  • ||||||||||  Vyrologix (leronlimab) / CytoDyn, Vyera Pharma, amfAR
    Journal:  Addition of a short HIV-1 fusion-inhibitory peptide to PRO 140 antibody dramatically increases its antiviral breadth and potency. (Pubmed Central) -  Mar 25, 2025   
    CCR5-directed antibody PRO 140 is currently under clinical trials, but it only inhibits CCR5-tropic HIV-1 isolates. The designed fusion proteins by adding a minimum fusion-inhibitory peptide to PRO 140 enable dramatically increased activities in inhibiting both CCR5-tropic and CXCR4-tropic viruses, thus offering novel antiviral agents with a bispecific functionality that can overcome the drawbacks of PRO 140 antibody.
  • ||||||||||  Journal, PD(L)-1 Biomarker:  Neoadjuvant BMS-813160, nivolumab, gemcitabine and nab-paclitaxel for patients with pancreatic cancer. (Pubmed Central) -  Mar 24, 2025   
    P1/2
    The designed fusion proteins by adding a minimum fusion-inhibitory peptide to PRO 140 enable dramatically increased activities in inhibiting both CCR5-tropic and CXCR4-tropic viruses, thus offering novel antiviral agents with a bispecific functionality that can overcome the drawbacks of PRO 140 antibody. Neoadjuvant BMS-813160/nivolumab/GnP was well tolerated and appears to achieve comparable ORR and resectability to historical data, however with prolonged PFS and OS in LA-PDAC patients, warranting a larger phase II study with a more efficacious CCR2-targeted therapeutic.
  • ||||||||||  CHS-114 / Coherus Biosci
    Enrollment change:  SRF114-101: Study of CHS-114 in Participants With Advanced Solid Tumors (clinicaltrials.gov) -  Mar 24, 2025   
    P1,  N=87, Recruiting, 
    Neoadjuvant BMS-813160/nivolumab/GnP was well tolerated and appears to achieve comparable ORR and resectability to historical data, however with prolonged PFS and OS in LA-PDAC patients, warranting a larger phase II study with a more efficacious CCR2-targeted therapeutic. N=47 --> 87
  • ||||||||||  Selzentry (maraviroc) / ViiV Healthcare, Tivicay (dolutegravir) / ViiV Healthcare
    Impact of Antiretroviral Therapy (ART) Intensification on HIV-1 Virologic Markers (ACTG 5324) (Poster Hall) -  Mar 3, 2025 - Abstract #CROI2025CROI_528;    
    One limitation of this finding is that the DTG+MVC arm exhibited a lower percentage of CA-2LTR detectable at baseline, despite randomization (Figure). The reduction of CA-2LTR detection with DTG+MVC may indicate suppression of residual replication, but other mechanisms are possible like altered migration of CA-2LTR-postive CD4+ T cells.