NJH395

NJH395 is a first-in-class immune-stimulator antibody conjugate (ISAC) designed for targeted cancer immunotherapy. It consists of a monoclonal antibody that targets human epidermal growth factor receptor 2 (HER2, also known as ERBB2) and is conjugated via a noncleavable linker to an agonist of Toll-like receptor 7 (TLR7). This design enables the selective delivery of the TLR7 agonist payload directly into HER2-expressing tumor cells, thereby activating myeloid cells and inducing type I interferon responses within the tumor microenvironment. The mechanism combines antigen targeting with local immune stimulation to enhance antitumor activity. Preclinical studies demonstrated potent activation of immune responses in vitro and in vivo, while phase I clinical trials in patients with HER2-positive advanced malignancies showed proof-of-mechanism but also revealed challenges such as cytokine release syndrome, neuroinflammation at high doses, and development of antidrug antibodies[1][6][4][5]. The drug was developed by Novartis.

Other names

anti-HER2 immune stimulator-antibody conjugate NJH395anti-HER-2 immune stimulator-antibody conjugate NJH395anti-HER 2 immune stimulator-antibody conjugate NJH395