BEIJING, China, April 7, 2026
Singlomics Biopharmaceuticals, a clinical-stage biotechnology company focused on antibody therapeutics, 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, marking a critical milestone in its global oncology drug development program. The trial will evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity in patients with advanced solid tumors, reinforcing the company’s commitment to advancing next-generation immuno-oncology therapies.
First-in-Human Study Advances Global Clinical Development
The initiation of dosing in this first-in-human Phase I clinical trial represents a significant step forward for Singlomics as it transitions DXP-106 from preclinical validation into clinical-stage development. The study has received Investigational New Drug (IND) approvals from both China’s NMPA and the U.S. FDA, highlighting strong regulatory alignment and enabling global development pathways.
DXP-106 is designed as a humanized monoclonal antibody targeting IL-1RAP, a receptor accessory protein involved in multiple inflammatory signaling pathways. The trial aims to generate early clinical data on safety and biological activity, which will be critical in determining the therapy’s dose optimization and future clinical expansion.
This milestone underscores the increasing importance of precision biologics and antibody-based therapies in oncology, particularly in targeting complex immune pathways within the tumor microenvironment.
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Novel Multi-Pathway Targeting Mechanism Enhances Therapeutic Potential
DXP-106 differentiates itself through its ability to simultaneously block IL-1, IL-33, and IL-36 signaling pathways, providing a multi-targeted approach to tumor suppression and immune modulation. By binding to a unique epitope on IL-1RAP domain 2, the antibody enables broad inhibition of pro-inflammatory signaling networks, which are known to contribute to tumor growth, immune evasion, and chronic inflammation.
In addition to pathway inhibition, DXP-106 is engineered to induce antibody-dependent cellular cytotoxicity (ADCC), allowing it to directly eliminate tumor cells while modulating the tumor microenvironment. Preclinical studies have demonstrated strong anti-tumor activity across multiple models, supporting its potential as a best-in-class therapeutic candidate.
IL-1RAP is widely expressed across tumor cells, stromal cells, and immune cells, making it a highly promising target for broad-spectrum oncology applications. Elevated IL-1 signaling has also been linked to poor clinical outcomes, further reinforcing the relevance of this therapeutic strategy.
Expanding Pipeline with AI-Driven Antibody Innovation
Singlomics continues to build a differentiated pipeline of antibody therapeutics using its proprietary platform that integrates single-cell sequencing, deep mutational scanning (DMS), and AI-driven antibody engineering. This advanced discovery engine enables the company to rapidly identify and optimize high-affinity antibodies, accelerating the development of next-generation biologics.
The company is actively seeking global partnerships to support the continued development and commercialization of its programs, reflecting a strategic focus on collaborative innovation and market expansion. With multiple candidates advancing toward clinical stages, Singlomics is positioning itself as a key player in the evolving immuno-oncology landscape.
The first patient dosing in the Phase I trial of DXP-106 marks a pivotal milestone in Singlomics’ clinical development journey, highlighting the potential of multi-pathway targeting monoclonal antibodies in cancer treatment. With strong preclinical data, global regulatory support, and an innovative discovery platform, the company is well-positioned to advance next-generation immunotherapies aimed at addressing high unmet needs in oncology.
As the field of precision medicine and biologics continues to evolve, therapies like DXP-106 underscore the importance of targeted immune modulation, clinical validation, and regulatory-driven development in shaping the future of biopharmaceutical innovation.
Source: Singlomics press release
