Doma Pharma (and its subsidiary Stow Pharmaceutical) recently announced that their self-developed bispecific antibody drug conjugate program DM001 has been approved for IND by the United States FDA. DM001 has also been approved for Clinical Trial Notification (CTN) by the Australian regulatory agency and entered clinical trials on June 26, 2024. As the development and manufacturing partner for this molecule, MabPlex congratulates Doma on their successful applications.
MabPlex provided comprehensive service from process development to IND submission for DM001; the 20th ADC program and 2nd bispecific antibody ADC program completed by the MabPlex team. This approval continues the recent momentum of antibody drug conjugates in the global cancer treatment field.
Bispecific antibody ADCs combine the advantages of bispecific antibodies and small molecule payloads to target tumor cells more specifically and overcome drug resistance. Through cross-linking, the synergistic endocytosis of both targets are promoted, improving the efficiency of toxin uptake and inhibiting growth signals by reducing the expression of receptor proteins.
DM001 targets epidermal growth factor receptor (EGFR) and human trophoblast surface antigen 2 (TROP2), which are co-expressed at high levels in a variety of solid tumors. DM001 leverages an enzyme-cleavable linker with a novel topoisomerase I inhibitor cytotoxin payload, which has demonstrated high potency and a favorable safety profile in preclinical studies. In-vivo studies showed significant growth inhibition across a variety of solid tumors with minimal off-target toxicity.
The upcoming Phase 1 global clinical trial of DM001 will enroll patients with multiple types of solid tumors, including breast cancer, EGFR wild-type and mutant non-small cell lung cancer, esophageal cancer, gastric cancer, colorectal cancer, et al, to explore the safety and tolerability of DM001 at different doses in humans, and evaluate its anti-tumor activity.
“The MabPlex team has pressed a ‘fast forward button’ for the DM001 program to be approved for clinical trials with compliant, professional, and efficient services,” expressed Dr. Song Jun, Co-CEO of Doma Pharma. ‘We look forward to verifying the anti-tumor potential of this compound in the clinic.”
Dr. Xinfang Li, CEO of MabPlex, said, “We are very honored to provide one-stop CDMO services for the DM001 project to advance the novel anti-tumor pipeline of Doma Therapeutics. MabPlex is committed to providing high-quality, customized CDMO services for global biopharmaceutical companies. I wish Doma all success in their clinical trials and positive results for the benefit of those suffering from cancer.”
Doma Pharma is a biomedical research and development organization with incubator support, which not only advances an innovative product line, but also anticipates the need for emerging innovation and development in the pharmaceutical industry. Supporting new ideas and technology contributes to the sustainable development of the healthcare industry and the well-being of patients.
MabPlex is a CDMO company focused on providing professional, customized, and integrated CDMO services for antibodies, antibody drug conjugates, recombinant proteins, and other biologic drugs. MabPlex is one of the few organizations in the world that can provide comprehensive services across the clinical production of antibody drug conjugates. At present, over one hundred submissions across a wide variety of large-molecule biologics have been successfully completed. With 10+ years of focus on antibody-drug conjugates, a mature technology platform, and an average of 20+ years across CMC team leadership, MabPlex has collaborated with biopharmaceutical companies in China, the United States, Europe, Korea, India, Australia, et al.
