China-based Doma Biopharmaceutical (Suzhou) Co., Ltd has announced that it has received clearance from the US Food and Drug Administration (FDA) to initiate a Phase I clinical study. The study will assess the safety, tolerability, and preliminary anti-tumor activity of its Category 1 drug DM002 in multiple solid tumors. This marks a significant milestone in the development of DM002, a promising bispecific antibody drug conjugate (ADC).
DM002: Targeting Multiple Cancers
DM002 is a bispecific ADC targeting human epidermal growth factor receptor 3 (HER3) and mucin 1 (MUC1), proteins that are co-overexpressed in multiple cancers. These include prostate cancer, ovarian cancer, endometrial cancer, pancreatic cancer, lung cancer, breast cancer, and colorectal cancer, among others. Pre-clinical studies have demonstrated DM002’s strong anti-tumor activity and good safety profile, positioning it as a potential therapeutic option for patients with these aggressive cancers.
Clinical Trial and Future Prospects
The Phase I clinical study will provide valuable insights into the safety and efficacy of DM002 in treating multiple solid tumors. The clearance from the FDA to proceed with this trial is a crucial step in bringing this innovative therapy closer to patients. Doma Biopharmaceutical is committed to advancing the clinical development of DM002, with the goal of improving treatment outcomes for patients with various types of cancer.-Fineline Info & Tech
