Singlomics Initiates First-in-Human Trial of DXP-106, Novel IL-1RAP Antibody for Advanced Solid Tumors
核心洞察
Singlomics Biopharmaceuticals (搜索) has dosed the first patient in a Phase I clinical trial of DXP-106, a humanized monoclonal antibody targeting IL-1RAP (搜索) in China.
DXP-106 represents a potential best-in-class therapeutic that simultaneously blocks IL-1 (搜索), IL-33 (搜索), and IL-36 (搜索) signaling pathways through binding to a unique epitope on IL-1RAP (搜索) domain 2.
The first-in-human study will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity in patients with advanced solid tumors (搜索).
Singlomics Biopharmaceuticals (搜索) has achieved a significant milestone by dosing the first patient in its Phase I clinical trial of DXP-106, a humanized monoclonal antibody targeting IL-1RAP (搜索), in China. The Beijing-based clinical-stage biopharmaceutical company announced this development as it advances its potential best-in-class therapeutic into human testing for patients with advanced solid tumors (搜索).
Novel Multi-Pathway Targeting Approach
DXP-106 distinguishes itself through its unique mechanism of action, specifically binding to a differentiated epitope on IL-1RAP (搜索) domain 2. This targeted approach enables simultaneous blockade of three key IL-1 (搜索) superfamily signaling pathways: IL-1, IL-33 (搜索), and IL-36 (搜索). According to the company, this multi-pathway inhibition strategy may provide broader anti-tumor activity and improved therapeutic benefit compared to single-pathway approaches.
The therapeutic is designed to function through dual mechanisms: directly killing tumor cells via antibody-dependent cellular cytotoxicity (ADCC) and inhibiting myeloid-derived suppressor cells (MDSCs) in the tumor microenvironment through the inhibition of multiple IL-1 (搜索) superfamily signaling pathways.
Clinical Trial Design and Regulatory Status
The ongoing first-in-human Phase I study is designed to evaluate multiple parameters including safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of DXP-106 in patients with advanced solid tumors (搜索). The trial represents a crucial step in the global development strategy for the antibody therapeutic.
DXP-106 has previously secured Investigational New Drug approvals from both the Center for Drug Evaluation of China's National Medical Products Administration and the U.S. Food and Drug Administration, positioning the company for potential international expansion of clinical development.
Target Validation and Therapeutic Rationale
IL-1RAP (搜索) serves as a compelling therapeutic target due to its broad expression across tumor cells, stromal cells, and immune cells within the tumor microenvironment. The protein plays a central role in tumor progression, immune evasion, and chronic inflammation. Clinical evidence supports the therapeutic potential of targeting this pathway, as elevated IL-1 (搜索) pathway signaling has been associated with poor clinical outcomes across multiple cancer (搜索) types.
In preclinical studies, DXP-106 demonstrated robust anti-tumor activity in both in vitro and in vivo tumor models, along with favorable developability characteristics that support its potential as a best-in-class therapeutic.
Company Platform and Future Outlook
Dr. Qian Shi, Chief Executive Officer of Singlomics, emphasized the significance of this milestone: "Dosing of the first patient in our Phase I trial represents a key milestone as we advance DXP-106 into clinical development globally. IL-1RAP (搜索) is a compelling target in oncology and immune-related diseases."
Singlomics has built an integrated platform combining single B cell discovery, deep mutational scanning, and AI-driven antibody engineering to enable rapid and high-quality antibody development. The company is advancing a differentiated pipeline of antibody therapeutics for oncology, inflammation, and autoimmune diseases, leveraging its proprietary single-cell sequencing and AI-enabled antibody engineering platform.
The company, which has completed Series B financing, is actively seeking global partnerships for selected programs as it looks to generate initial clinical data and explore potential collaboration opportunities to accelerate development of DXP-106 and other pipeline candidates.