IBD: a disease with highest prevalence in developed countries
- Inflammatory bowel disease (IBD) includes ulcerative colitis (UC) and Crohn’s disease (CD)
- More than 1 million Americans and 2.5 million Europeans have IBD, and rates are rising rapidly in other parts of the world
- A large number of patients do not respond to existing drugs
TL1A : A key mediator in IBD
- TL1A is a member of the TNF superfamily and mainly exists in the form of soluble trimer proteins
- TL1A binds to DR3 and activates TRADD-mediated inflammatory pathways
- TL1A is a key mediator of intestinal inflammation, regulating both inflammation and fibrotic pathways
- TL1A-DR3 promote the proliferation and activation of Th1, Th17 and other cells to activate the inflammatory pathway
Competitor analysis: There are still unmet clinical needs for TL1A antagonists
Advantages of our product:
1. Lowering the immunogenicity risk through our proprietary technology
- Target-dependent immunogenicity: The target-dependent immunogenicity of candidate antibodies was screened by our proprietary technology and our product showed the biggest potential to avoid the immunogenicity associated with PF1D1 (RVT3101) and AMG966
- Sequence-dependent immunogenicity: our product showed the lowest immunogenicity risk through the AI immunogenicity prediction software compared to PF1D1 (RVT3101), PR34 (PRA023) and other candidates
2. Our product showed excellent affinity for human trimer or monomer-TL1A
3. Our product showed superior in vitro potency by protein-based or cell-based assay
4. Cell binding and ADCC assay(HEK293-hTL1A): Our product showed excellent cell binding ability and no ADCC effect
5. Our product is specific for TL1A and crosses react with TL1A from different Species: Our product shows excellent specificity; Our product crosses react with TL1A from different Species
6. Stability assay and Developability prediction of high-concentration formulation: Our product showed excellent stability: Physicochemical and biological properties of Our product remained stable at 40℃ for 14 days; Our product showed the highest developability of high-concentration formulation through prediction of aggregation risk under high concentration of antibody by AI software
7. Fc engineering increases half-life of Product(PK in hFcRn-mice): The half-life of Our product was extended by 2.5 times and the AUC was doubled in hRcRn-mice through different long-acting designs
Summary: A potential best-in-class anti-TL1A mAb to treat IBD
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