Doma Biopharmaceutical (Suzhou) Co., Ltd, a biopharmaceutical company based in China, has announced that it has received clinical trial approval from the U.S. Food and Drug Administration (FDA) for its bispecific antibody drug conjugate (ADC), DM001. The molecule is set to be evaluated for safety, tolerability, and preliminary anti-tumor activity across a range of tumor types, including breast cancer, EGFR wild type and mutant non-small cell lung cancer, esophageal cancer, gastric cancer, and colorectal cancer. A global Phase I study is expected to commence shortly in Australia, following IND approval received late last month.
DM001 targets epidermal growth factor receptor (EGFR) and human trophoblast surface antigen 2 (TROP2), both of which are co-expressed and highly expressed in various solid tumors. These receptors play a critical role in processes such as cell proliferation, invasion, and metastasis. Pre-clinical studies have demonstrated DM001’s potent anti-tumor activity and favorable safety profile.- Flcube.com
