Key Findings
Sofusa Holdings is advancing the DoseConnect platform, which utilizes nanotopography-draped microneedles to deliver biologic therapies directly into the lymphatic system. In a Phase 1b study of 10 patients with moderate-to-severe rheumatoid arthritis who failed to improve on 50 mg of subcutaneous etanercept, switching to lymphatic delivery at a reduced dose of 25 mg resulted in a 70% reduction in tender joints, a 62% reduction in pain, and a 34% improvement in DAS28-ESR. Additionally, in a Phase 1b study at City of Hope for cutaneous T-cell lymphoma (CTCL), two of three patients with advanced disease responded to lymphatic delivery of pembrolizumab after failing prior treatments.
Technical Details
The platform targets the lymphatic vessels and lymph nodes where key immune targets reside. Preclinical biodistribution studies indicate that this method achieves up to 80-fold higher drug concentrations in lymph nodes compared to conventional subcutaneous administration, while maintaining lower concentrations in off-target organs. Because the system is compatible with already-approved biologic medicines, the company expects a more efficient development pathway with reduced costs and timelines. Potential applications include bispecific antibodies and oncolytic virus therapies to reduce systemic toxicity.
Background and Context
The technology was originally developed at Kimberly-Clark and further advanced through clinical trials under Sorrento Therapeutics, with cumulative investment totaling approximately $100 million. New investors have since acquired the rights to launch Sofusa as an independent entity. The company has restarted manufacturing to develop a pipeline for autoimmune diseases, cancer, and other immune system disorders.
Significance and Outlook
Sofusa plans to submit its first FDA application for a Class II device for intradermal delivery of biologics in Q2 2027. The company’s leadership emphasizes that direct access to the lymphatic network may allow for lower drug dosages to achieve superior therapeutic outcomes. Sofusa will present further details at the MedTech Strategist Innovation Summit in San Diego on November 4, 2026.
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