On January 12, 2025, DM002, a first-in-class bispecific antibody-drug conjugate (ADC) targeting HER3 and MUC1-C independently developed by Doma Biopharmaceutical (Suzhou) Co., Ltd., officially obtained Investigational New Drug (IND) approval from the U.S. FDA, paving the way for Phase I clinical trials. DM002 marks the third bispecific ADC candidate from Doma to secure FDA IND clearance.
DM002 employs a dual-target strategy directed at tumor-associated antigens HER3 (human epidermal growth factor receptor 3) and MUC1-C (mucin 1 C-terminal subunit), both of which are highly co-expressed in multiple cancers, including prostate, ovarian, endometrial, pancreatic, lung, breast, and colorectal cancers. By simultaneously binding to these two antigens, DM002 enhances tumor tissue specificity, promotes cellular internalization, and improves the targeted delivery of cytotoxic payloads to tumors. This mechanism maximizes antitumor efficacy while minimizing off-target effects on healthy cells, thereby reducing systemic toxicity.
In preclinical studies, DM002 demonstrated robust antitumor activity and a favorable safety profile. Notably, in animal models, DM002 significantly suppressed the growth of various solid tumors and exhibited excellent tolerability with no significant toxicities observed. These promising data lay a solid foundation for its clinical development.
The upcoming global Phase I trial will enroll patients with multiple solid tumor types, including prostate, ovarian, endometrial, pancreatic, small cell lung, colorectal, and breast cancers. The study aims to evaluate the safety, tolerability, and preliminary antitumor activity of DM002 across different dose levels. Findings from this phase will provide critical insights to guide further clinical development and accelerate DM002’s potential to benefit cancer patients worldwide.
"Bispecific ADCs represent an innovative strategy in cancer therapeutics, enhancing efficacy and reducing toxicity through improved tumor targeting, payload delivery, and potential to overcome drug resistance. DM002, as our third bispecific ADC entering clinical trials, underscores Doma’s robust R&D capabilities," stated Dr. Chen Rong, Chief Medical Officer of Doma Medicines. "We are committed to pioneering transformative therapies that extend survival and improve quality of life for cancer patients, while injecting new momentum into global oncology innovation."
