Recently, the FDA has cleared an Investigational New Drug (IND) application allowing RemeGen, China-based biopharmaceutical company, to initiate a Phase II clinical trial of Disitamab Vedotin, to test the drug as a potential new treatment for human epidermal growth factor receptor 2 (HER2) positive metastatic or unresectable urothelial cancer.

Figure 1: Disitamab Vedotin structure.

Disitamab Vedotin is a new type of humanized anti-HER2 antibody-drug conjugate or ADC for the treatment of several solid tumors that express HER2. It conjugates the humanized HER2 targeting monoclonal antibody-cit-PABC with the monomethyl auristatin E (MMAE) payload through the cleavable linker maleimidohexanoyl-pentyl-citrulline-p-amino benzyloxy carbonyl (mc-val). Its mechanism of action includes inhibition of the HER2 signaling pathway and the cytotoxicity of MMAE. It has higher anti-tumor activity compared with other treatment methods in animal models. The new drug is China's first ADC drug approved for human clinical trials, and it has now been studied in multiple late-stage clinical trials targeting solid tumor types.

Table 1: Details of Disitamab Vedotin

Continuous development

In China, the development of Distamab Vedotin involves 5 indications, including gastric cancer, urothelial cancer, advanced breast cancer, non-small cell lung cancer (NSCLC), and cholangiocarcinoma. The drug has been designated as an orphan drug by the FDA and is currently undergoing key clinical trials in China to treat patients with gastric cancer and urothelial cancer.

Today, there are eight approved ADCs on the market. ADC has become a powerful therapeutic agent in oncology and hematology.