RNDO-564

RNDO-564 is a novel, fully human bispecific antibody developed by Rondo Therapeutics for the treatment of solid tumors, with an initial focus on advanced bladder cancer. It targets both CD28 (a T cell co-stimulatory receptor) and Nectin-4 (a tumor-associated antigen), functioning as a CD28 x Nectin-4 costimulatory bispecific antibody. The drug is designed to selectively engage and activate immune cells within the tumor microenvironment by providing localized co-stimulation to T cells at the site of Nectin-4-expressing tumors, thereby boosting T cell-mediated cytotoxicity and overcoming T cell exhaustion—a key limitation in current immunotherapies for solid tumors. Preclinical studies have demonstrated robust anti-tumor activity both in vitro and in vivo, including efficacy against antibody-drug conjugate-resistant bladder cancer models. The molecule has shown favorable safety profiles in non-human primates and is advancing toward first-in-human clinical trials[1][3][6][8].