Onvatilimab (JNJ-61610588): A Clinical Development Review of a Discontinued VISTA-Targeting Monoclonal Antibody

1. Executive Summary

JNJ-61610588, also known by the non-proprietary name Onvatilimab, is an investigational human IgG1κ monoclonal antibody.[1] It was developed by Janssen Research & Development, LLC, a pharmaceutical company of Johnson & Johnson, with the objective of targeting advanced solid tumors.[2] The antibody was designed to bind to V-domain Ig Suppressor of T-cell Activation (VISTA), a negative immune checkpoint protein.[1] As a VISTA antagonist, Onvatilimab's intended mechanism of action was to block VISTA-mediated immune suppression, thereby enhancing anti-tumor T-cell responses within the tumor microenvironment.[2]

The primary clinical investigation for Onvatilimab was a Phase 1 trial, registered under NCT02671955, which commenced in January 2016. This study aimed to evaluate the safety, pharmacokinetics, and pharmacodynamics of Onvatilimab in participants with various advanced solid tumors.[1] However, the clinical trial was terminated prematurely by the sponsor after enrolling only 12 participants.[2] Subsequent to this termination, JNJ-61610588 (Onvatilimab) has not appeared in Janssen's publicly disclosed active oncology development pipeline, signaling a discontinuation of its development program.[5]