Auristatin drugs having highly stable hydrophilic linker units and conjugates thereof

By linking auristatin derivatives to an enzyme peptide unit via an aminomethylene structure, the new ADCs improve safety and efficacy, addressing neurotoxicity and hematotoxicity, and enhancing plasma stability, thus achieving better tumor inhibition with lower doses.

JP2025532285APending Publication Date: 2025-09-29SYSTIMMUNE INC
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Patent Information

Application Number
JP2025518396
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-09-25
Filing Date
2023-09-28
Publication Date
2025-09-29

AI Technical Summary

Technical Problem

Current auristatin-based antibody-drug conjugates (ADCs) face challenges with neurotoxicity, hematotoxicity, and poor plasma stability due to hydrophobic linkers, leading to limited DAR and efficacy, and existing linker modifications suffer from instability and off-target toxicity.

Method used

Auristatin or its derivatives are linked to an enzyme peptide unit via an aminomethylene structure at the hydroxyl site, increasing DAR to 8, enhancing hydrophilicity and plasma stability, and reducing neurotoxicity and hematotoxicity.

Benefits of technology

The new linker-payload conjugates achieve superior efficacy with lower doses, improved maximum tolerated dose (MTD), and reduced side effects, while maintaining tumor-inhibiting effects.

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Abstract

The present invention relates to the medical technology field and relates to auristatin drugs and conjugates thereof having highly stable hydrophilic linker units. In particular, the present invention relates to ligand-drug conjugates or pharmaceutically acceptable salts or solvates thereof, and methods for preparing and using the same. The present invention also relates to linker-drug compounds or their isomers, meso-isomers, racemates, enantiomers, or mixtures thereof, or pharmaceutically acceptable salts or solvates thereof, and methods for preparing and using the same.
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