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Doma's bispecific ADC, DM001, has received US FDA IND clearance

Source:Doma
Time:2024-07-04

On July 4th, 2024, Doma and its affiliate, Xadcera, officially received IND clearance from U.S. FDA for their first bispecific ADC asset, DM001. Prior to that, Doma also officially obtained CTN approval from Australia on Jun 26th, which indicates DM001 global phase 1 trial is coming.

 

DM001 is designed on a bispecific strategy targeting tumor-associated antigens, e.g. the epidermal growth factor receptor (EGFR) and human trophoblast cell surface antigen 2 (TROP2).  EGFR and TROP2 are co-expressed and overexpressed in various solid tumors, different from normal tissues, and paly important roles in tumor cell proliferation, invasion and metastasis. By simultaneously targeting these two tumor-associated antigens with synergistic endocytosis, DM001 is expected to specifically deliver cytotoxic payloads to tumor cells, rather than normal tissues.

 

ADC, as a cutting-edge technology of current anti-cancer treatment, combines monoclonal antibodies with high affinity/specificity and the potent cytotoxic toxins, minimizing off-target cytotoxic damage to healthy cells. EGFR and TROP2 bispecific monoclonal antibody linking with a potent TOPO inhibitor as the payload of DM001 provides direct tumor cell killing effects as well as bystander killing effects. The bispecific antibody of DM001 is from common light chain technology platform with synergistic endocytosis of two arms, aiming for easy and consistent manufacture, improved efficacy and safety.

 

In the early preclinical studies, DM001 has shown strong anti-tumor activity and good safety. Animal studies indicate that DM001 can achieve tumor regression in various solid tumor models, with good tolerance and no significant toxic observations. These data have laid a solid foundation for clinical study.

 

The upcoming global Phase 1 study will recruit patients with various types of solid tumors, including breast cancer, EGFR wild-type and mutant non-small cell lung cancer, esophageal cancer, gastric cancer, colorectal cancer, etc., aiming to explore the safety and tolerance of DM001 in humans at different doses and preliminarily evaluate its anti-tumor activity. The results of this study will provide key indicators for further clinical development.

 

Dr. SONG Jun, Co-CEO of Doma, said: "We are confident in the preclinical efficacy and safety data of DM001 and excited to verify its anti-tumor potentials in clinical trials. Doma is committed to provide valuable and transformative assets to improve quality of life for cancer patients cross the world."

 

The successful clearance of DM001 US IND is not only an important milestone for Doma, but also propels the development of a new anticancer drug. We look forward to continuing the development of this innovative drug, verifying the efficacy and safety in human and benefiting patients as soon as possible.