Doma Biopharmaceutical (Suzhou) Co., Ltd, a biotech firm with a presence in China and the United States, has received approval from China’s National Medical Products Administration to commence a clinical study for its innovative Category 1 drug DM001. This bispecific antibody drug conjugate (ADC) is designed to target advanced or metastatic hormone receptor positive (HR+), HER2- breast cancer, metastatic triple negative breast cancer (mTNBC), and advanced or metastatic EGFRmut or EGFRwt non-small cell lung cancer (NSCLC), among other solid tumors.
DM001, which targets epidermal growth factor receptor (EGFR) and trophoblast cell-surface antigen 2 (TROP2), has demonstrated robust anti-tumor activity and an excellent safety profile in prior clinical studies. This ADC is based on Doma’s Harbour Mice platform and is the first of its kind to enter clinical trials globally. It has shown enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) activity and high specificity towards Treg cells that highly express CTLA-4 in the tumor microenvironment.
The drug is currently in Phase I studies in patients with solid tumors, including breast cancer, EGFR wild type and mutant non-small cell lung cancer, esophageal cancer, gastric cancer, colorectal cancer, etc., in the US and Australia, having obtained clinical approval in the US in July 2024. The upcoming global Phase 1 study aims to recruit patients with various types of solid tumors to explore the safety, tolerability, and preliminary anti-tumor activity of DM001 at different doses .- Flcube.com
