Keymed Biosciences announced today that its novel CDH17-targeted antibody-drug conjugate (ADC), CM518D1, has received Investigational New Drug (IND) approval from China's National Medical Products Administration (NMPA). The drug is currently advancing through Phase I/II clinical trials in China for the treatment of solid tumors, particularly gastrointestinal cancers.
This regulatory milestone represents a significant advancement in Keymed's oncology pipeline and strengthens the company's position in the rapidly evolving ADC therapeutic landscape.
Novel Mechanism Targeting Gastrointestinal Cancers
CM518D1 targets Cadherin-17 (CDH17), a member of the cadherin superfamily that has emerged as a promising therapeutic target in gastrointestinal malignancies. Research has shown that CDH17 is highly expressed in multiple gastrointestinal cancers, including colorectal, gastric, pancreatic, and esophageal cancers, where it plays a critical role in tumor invasion and metastasis.
Dr. Bo Chen, CEO of Keymed Biosciences, emphasized the potential impact of this approach: "Gastrointestinal cancers represent a significant global health burden with limited targeted treatment options. Our CDH17-targeted ADC addresses a critical unmet need by specifically targeting cancer cells while sparing healthy tissue."
The therapeutic mechanism of CM518D1 involves a CDH17-specific monoclonal antibody that delivers cytotoxic payloads precisely to tumor cells. This approach combines the targeting specificity of antibodies with the potent cell-killing capabilities of chemotherapeutic agents.
Promising Preclinical Results
Preclinical studies have demonstrated CM518D1's impressive therapeutic profile. The drug exhibits strong direct cytotoxic activity against cancer cells, potent bystander killing effects on neighboring tumor cells, and excellent plasma stability.
In multiple solid tumor xenograft models, CM518D1 demonstrated remarkable anti-tumor efficacy while maintaining a favorable safety profile and wide therapeutic window in toxicological evaluations. These characteristics are particularly important for ADCs, which must balance potent cytotoxicity with acceptable safety margins.
Clinical Development Strategy
Keymed is currently conducting Phase I/II clinical trials in China to evaluate the safety, tolerability, and preliminary efficacy of CM518D1 in patients with advanced solid tumors. The initial focus is on patients with gastrointestinal cancers that express the CDH17 target.
"Our clinical development program aims to establish CM518D1 as a precision medicine option for patients with gastrointestinal cancers," said Dr. Chen. "The Phase I/II trials will help us identify the optimal dosing regimen and patient populations most likely to benefit from this targeted approach."
The company plans to expand clinical investigations based on initial results, with the ultimate goal of providing a more precise, effective, and safer therapeutic option for patients worldwide with gastrointestinal cancers.
Advanced ADC Platform Technology
CM518D1 is developed using Keymed's proprietary ADC platform, which incorporates several technological innovations. The platform enables the development of next-generation ADCs featuring novel payloads with diverse mechanisms of action, hydrophilic linkers optimized for stability and controlled drug release, and engineered antibodies with enhanced binding properties and pharmacokinetics.
To support its ADC development program, Keymed has established GMP-compliant facilities dedicated to linker-payload and ADC drug substance production. This infrastructure investment positions the company to accelerate the development of its ADC pipeline and address manufacturing challenges that often complicate ADC development.
Addressing Significant Unmet Needs
Gastrointestinal cancers collectively represent one of the most significant cancer burdens globally. Colorectal cancer alone is the third most commonly diagnosed cancer worldwide, with approximately 1.9 million new cases annually. Current treatment options for advanced gastrointestinal cancers remain limited, with many patients experiencing disease progression despite available therapies.
The targeted approach of CM518D1 could potentially offer improved efficacy with reduced systemic toxicity compared to conventional chemotherapy regimens. If successful in clinical trials, this ADC could address a significant treatment gap for patients with gastrointestinal malignancies.
Company Background
Keymed Biosciences Inc. (HKEX: 02162) is a biotechnology company focused on addressing urgent unmet clinical needs. The company is committed to developing high-quality, affordable, innovative therapies for patients in China and globally. Founded by medical and scientific experts with extensive experience in translational medicine and commercialization, Keymed has built a diverse pipeline of novel therapeutics across multiple disease areas.
The advancement of CM518D1 into clinical trials represents another step in Keymed's mission to develop innovative therapies that address significant unmet medical needs in oncology and beyond.
