- |||||||||| afimkibart (RG6631) / Roche
Enrollment closed, Trial completion date, Trial primary completion date: A Study to Assess the Safety, Pharmacokinetics, and Activity of RO7790121 in Participants With Advanced MASH Liver Fibrosis (clinicaltrials.gov) - Oct 16, 2025 P1, N=50, Active, not recruiting, Trial completion date: Dec 2028 --> Apr 2029 Recruiting --> Active, not recruiting | Trial completion date: Sep 2026 --> Dec 2026 | Trial primary completion date: Sep 2026 --> Dec 2026
- |||||||||| LBL-053, A Novel Anti-TL1A/p40 Bispecific Antibody for the Treatment of Autoimmune Disorders. [WITHDRAWN] (Hall F1) - Sep 15, 2025 - Abstract #ACRConvergence2025ACR_Convergence_1524;
Ustekinumab, targeting p40 subunit, has demonstrated robust efficacy and approved for IBD...The effect of LBL-053 on inhibiting TL1A-DR3 downstream signaling pathway was comparabile to RVT-3101, but better than MK-7240 and PF-07261271.LBL-053 also significantly blocked IL-23/IL-12R?1 interaction... LBL-053 showed dual immunosuppressive functions, simultaneously inhibiting TL1A-DR3 and IL-23/IL-12R?1 signaling pathway, indicating promising clinical applications for the treatment of autoimmune diseases.
- |||||||||| afimkibart (RG6631) / Roche
AFIMKIBART (ANTI-TL1A) IS EFFECTIVE IN THE BLOCKADE OF CELLULAR SIGNALING INDUCED BY ACTIVE TL1A (Science Lounge) - Jul 9, 2025 - Abstract #UEGW2025UEGW_2856; While some signaling activity was observed at high concentrations of monomeric TL1A protein, we hypothesize that any signaling observed with monomeric form is likely due to the formation of trimers, which are efficiently blocked by afimkibart. Overall, any monomeric TL1A present should not be functionally active nor be available as a sink for afimkibart, thus preserving the optimal pharmacokinetic (PK) and pharmacodynamic (PD) properties needed for effective target inhibition.
- |||||||||| HXN-1003 / Sanofi, RG6631 / Roche, Skyrizi (risankizumab-rzaa) / AbbVie, Boehringer Ingelheim
DESIGN AND DEVELOPMENT OF A BISPECIFIC ANTIBODY TARGETING IL23 AND TL1A FOR ENHANCED THERAPEUTIC EFFICACY (Halls C-E, Lower Level - SDCC) - Mar 8, 2025 - Abstract #DDW2025DDW_2995; The anti-TL1A arm of HXN-1003 binds both the trimeric and monomeric forms of TL1A with sub-nanomolar affinity, exhibiting strong blocking activity in TF-1 apoptosis assays and DR3-NF?B-Luc reporter assays, with results comparable to its parent antibody HXN-1001 and the benchmark RVT-3101...The TL1A/IL23 bsAb targets two key drivers of immune dysregulation in autoimmune diseases, demonstrating both synergistic and additive therapeutic effects in vitro and in vivo. These results highlight its potential to improve clinical outcomes in patients with autoimmune diseases across multiple indications.
- |||||||||| AI-GUIDED DESIGN AND DEVELOPMENT OF HXN-1001: A POTENT, HALF-LIFE-EXTENDED ANTI-TL1A ANTIBODY (Halls C-E, Lower Level - SDCC) - Mar 8, 2025 - Abstract #DDW2025DDW_2986;
In addition, in an imiquimod (IMQ)-induced psoriasis model, HXN-1001 outperformed the marketed anti-IL23 monoclonal antibody Risankizumab in reducing psoriatic-like inflammation, suggesting its utility in broader immune-mediated conditions...The preclinical data collectively establish HXN-1001 as a promising therapeutic candidate with broad immunomodulatory capabilities, superior efficacy compared to current standards, and an extended dosing profile suited for chronic inflammatory and autoimmune diseases. HXN-1001 is anticipated to enter clinical development in Q2 2025.
- |||||||||| afimkibart (RG6631) / Roche
Trial completion date, Trial primary completion date: TAHOE: RO7790121 for the Treatment of Moderate to Severe Active Crohn's Disease (clinicaltrials.gov) - Sep 27, 2024 P2, N=21, Active, not recruiting, This article gives a short update and overview, where we are at this point in time with antibodies targeting the TL1A protein in IBD. Trial completion date: Dec 2025 --> Dec 2030 | Trial primary completion date: Jul 2024 --> Dec 2030
- |||||||||| RG6631 / Roche, SAR447189 / Teva, Sanofi, tulisokibart (MK-7240) / Merck (MSD)
Review, Journal: TL1A inhibition for inflammatory bowel disease treatment: From inflammation to fibrosis. (Pubmed Central) - May 11, 2024 Results are eagerly awaited, marking advancements in IBD therapeutics. This critical review comprehensively examines the existing literature, illuminating TL1A and the intricate role of DR3 in IBD, emphasizing the evolving therapeutic landscape and ongoing clinical trials, with potential implications for more effective IBD management.
- |||||||||| afimkibart (RG6631) / Roche
Enrollment closed, Enrollment change, Trial primary completion date: TAHOE: RO7790121 for the Treatment of Moderate to Severe Active Crohn's Disease (clinicaltrials.gov) - Feb 2, 2024 P2, N=20, Active, not recruiting, This critical review comprehensively examines the existing literature, illuminating TL1A and the intricate role of DR3 in IBD, emphasizing the evolving therapeutic landscape and ongoing clinical trials, with potential implications for more effective IBD management. Recruiting --> Active, not recruiting | N=105 --> 20 | Trial primary completion date: Dec 2024 --> Jul 2024
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