On November 28, 2024, DM005, a Class 1 innovative drug independently developed by Doma Biopharmaceutical (Suzhou) Co., Ltd. — an EGFR/c-MET bispecific antibody-drug conjugate (bsADC) for injection — had its Clinical Trial Application Notice approved by China's National Medical Products Administration (NMPA), and patient enrollment has commenced in China. Earlier, on August 29 and September 11, 2024, DM005 also received approvals from the U.S. FDA and Australia's Therapeutic Goods Administration (TGA), respectively, to initiate Phase I clinical studies. The first patient was dosed on November 21, 2024.
DM005 is a bispecific antibody-drug conjugate (bsADC) targeting both the mesenchymal-epithelial transition factor (c-MET) and epidermal growth factor receptor (EGFR). Unlike in normal tissues, EGFR and c-MET are co-overexpressed in various solid tumors. By simultaneously targeting these two tumor-associated antigens, DM005 enhances specificity toward tumor tissues, improves internalization, and more effectively delivers cytotoxic payloads to tumor tissues, thereby maximizing antitumor activity while minimizing damage to healthy cells and reducing toxicity.
In previous preclinical studies, DM005 demonstrated robust antitumor activity and favorable safety. Results from multiple animal model experiments showed that DM005 significantly inhibited the growth of various solid tumors with good tolerability. These positive data laid a solid foundation for its clinical development.
The ongoing global Phase I clinical trial is enrolling patients with various types of solid tumors, including EGFR-mutant or wild-type non-small cell lung cancer and head and neck cancer. The study aims to evaluate the safety and tolerability of DM005 at different doses in humans and preliminarily assess its antitumor activity. Findings from this phase will provide critical data for subsequent clinical development.
"DM005 has completed the first patient dosing in the United States. We are confident in its preclinical data and hope that DM005 will validate its significant potential in antitumor therapy during clinical studies, ultimately benefiting cancer patients in China and worldwide," said Dr. Chen Zhaorong, Chief Medical Officer of Doma. "Doma is committed to providing cancer patients with more survival opportunities and improved quality of life through innovative therapies."
