Product Description
LY4052031 is a fully human monoclonal anti-Nectin-4 antibody conjugated to a novel TOPO 1 inhibitor by a cleavable peptide linker at a homogeneous drug antibody ratio (DAR) of 8:1. In vitro, both LY4052031 and its unconjugated parental antibody specifically bind to Nectin-4 expressing cell lines and are quickly and efficiently internalized. LY4052031 demonstrated potent cytotoxicity on tumor cells with high and low Nectin-4 expression. Additionally, bystander activity exerted by LY4052031 on antigen negative cells co-cultured with antigen positive cells was greater than that observed with the clinical benchmark enfortumab vedotin-ejfv. In vivo studies in xenografts expressing low to high levels of Nectin-4 showed significant tumor growth inhibition following treatment with LY4052031 as monotherapy. Overall, LY4052031 exhibits specificity, selectivity, potency, and effectiveness as a next generation therapy to treat Nectin-4 positive tumors. An IND submission is planned for 2024. (Sourced from: https://aacrjournals.org/cancerres/article/84/6_Supplement/1872/739225/Abstract-1872-A-next-generation-treatment-for)
Mechanisms of Action: NECTIN4 Inhibitor
Novel Mechanism: No
Modality: Antibody Drug Conjugate
Route of Administration: N/A
FDA Designation: None *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Eli Lilly
Company Location: INDIANAPOLIS IN 46285
Company CEO: David A. Ricks
Additonal Commercial Interests: None
Clinical Description
![Map of Global Clinical Trials for LY-4052031](https://pryzm-maps.s3.us-west-2.amazonaws.com/666666current_maps.png)
Countries in Clinic: United States
Active Clinical Trial Count: 2
Highest Development Phases
Phase 1: Bladder Cancer|Cervical Cancer|Esophageal Cancer|Head and Neck Cancer|Non-Small-Cell Lung Cancer|Ovarian Cancer|Pancreatic Cancer|Pelvic Cancer|Prostate Cancer|Renal Cell Carcinoma|Squamous Cell Carcinoma|Transitional Cell Carcinoma|Triple Negative Breast Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
---|---|---|---|---|---|
NEXUS-01 | P1 |
Recruiting |
Renal Cell Carcinoma|Head and Neck Cancer|Bladder Cancer|Squamous Cell Carcinoma|Pelvic Cancer|Pancreatic Cancer|Non-Small-Cell Lung Cancer|Cervical Cancer|Esophageal Cancer|Ovarian Cancer|Prostate Cancer|Triple Negative Breast Cancer |
2027-05-01 |
|
jRCT2031240303 | P1 |
Not yet recruiting |
Transitional Cell Carcinoma |
2026-12-31 |