Keymed Biosciences Secures Research Approval for ADC Targeting Solid Tumors
On April 27, 2025, Keymed Biosciences Inc. (HKEX: 02162) made a significant announcement regarding CM518D1, an advanced antibody-drug conjugate (ADC) targeting CDH17. This innovative treatment received approval as a new research drug from the National Medical Products Administration of China and is currently undergoing phase I/II clinical trials in China for patients with solid tumors. This marks a crucial development in Keymed's portfolio of oncology therapies.
Understanding CM518D1 and Its Mechanism of Action
The CM518D1 targets CDH17 (Cadherin 17), a member of the cadherin superfamily, which has emerged as a promising therapeutic target in gastrointestinal cancers. Research indicates that CDH17 is significantly overexpressed in several gastrointestinal malignancies like colorectal cancer, gastric cancer, pancreatic cancer, and esophageal cancer. Its role in tumor invasion and metastasis underscores its importance as a target for therapy.
CM518D1 functions by delivering cytotoxic payloads directly to tumor cells, leveraging a monoclonal antibody that specifically binds to CDH17. This combination of antibody specificity and potent chemotherapy provides a promising therapeutic approach. Preclinical studies highlight that CM518D1 exhibits strong direct cytotoxicity, notable spectator effects, and excellent plasma stability. It has shown remarkable anti-tumor efficacy across various solid tumor xenograft models, alongside a favorable safety profile and a wide therapeutic margin in toxicological assessments.
Clinical Development and Future Prospects
Keymed is currently conducting phase I/II clinical trials in China to evaluate CM518D1's safety, tolerability, and preliminary efficacy in patients with advanced solid tumors. This research aims to deliver a more precise, effective, and safer treatment option for gastrointestinal cancer patients globally. As the studies progress, the therapeutic promise of CM518D1 could greatly impact patient care in oncology.
Keymed's Innovative ADC Platform
The proprietary ADC platform of Keymed facilitates the design of next-generation ADCs featuring new payloads with various mechanisms of action, optimized hydrophilic linkers for stability and drug release, and modified antibodies improving binding and pharmacokinetics. The company has established facilities compliant with good manufacturing practices for the production of linker-payloads and ADCs. This infrastructure positions Keymed at the forefront of ADC therapeutic development, catering to unmet medical needs for patients worldwide.
About Keymed Biosciences
Keymed Biosciences Inc. is a biotechnology firm dedicated to addressing urgent clinical needs and committed to providing innovative, affordable, and high-quality treatments to patients in China and globally. Founded by industry veterans with extensive experience converting scientific and technological breakthroughs into marketable solutions, Keymed is poised to make significant inroads in the cancer treatment landscape. With the advancement of CM518D1, Keymed not only enhances its therapeutic pipeline but also opens new paths for research and innovation in ADCs, aiming for a future where cancer treatment can be more effective and patient-centered.