Singlomics Biopharmaceuticals, an innovative clinical-stage biopharmaceutical company focused on the discovery and development of antibody therapeutics for oncology, inflammation, and autoimmune diseases, announced that the first patient has been dosed in its Phase I clinical trial of DXP-106, a potential best-in-class IL-1RAP monoclonal antibody, in China.

DXP-106 has previously received Investigational New Drug (IND) approvals from both the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA). The ongoing first-in-human Phase I study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of DXP-106 in patients with advanced solid tumors.

"Dosing of the first patient in our Phase I trial represents a key milestone as we advance DXP-106 into clinical development globally," said Dr. Qian Shi, Chief Executive Officer of Singlomics. "IL-1RAP is a compelling target in oncology and immune-related diseases. DXP-106 is designed to function through both directly killing tumor cells by ADCC, and inhibit MDSCs  in tumor microenvironment via inhibition of multiple IL-1 superfamily signaling pathways. It has demonstrated strong anti-tumor activity in preclinical studies. We look forward to generating initial clinical data and exploring potential global partnering opportunities to accelerate development."

DXP-106 is a humanized monoclonal antibody that specifically binds to a differentiated epitope on IL-1RAP domain 2, enabling simultaneous blockade of IL-1, IL-33, and IL-36 signaling pathways. This multi-pathway inhibition approach may provide broader anti-tumor activity and improved therapeutic benefit.

IL-1RAP is broadly expressed across tumor cells, stromal cells, and immune cells within the tumor microenvironment, and plays a central role in tumor progression, immune evasion, and chronic inflammation. Elevated IL-1 pathway signaling has been associated with poor clinical outcomes across multiple cancer types, supporting IL-1RAP as a promising therapeutic target.

Singlomics is advancing a differentiated pipeline of antibody therapeutics leveraging its proprietary single-cell sequencing and AI-enabled antibody engineering platform. The Company is actively seeking global partnerships for selected programs.