Precision lymphatic targeting platform validated with clinical data in both Rheumatoid Arthritis and in Cancer; Class II Device FDA submission planned in Q2 2027.

Sofusa Holdings today announced its launch as an independent, clinical-stage company pioneering the development of a proprietary nanotechnology platform for precision targeting of lymphatic vessels and lymph nodes. The company has restarted manufacturing and plans to develop a pipeline of combination biologic products for autoimmune diseases, cancer and potentially other disorders of the immune system. In early human proof-of-concept clinical studies, the company’s DoseConnect^® platform demonstrated the therapeutic impact of lymphatic drug delivery in rheumatoid arthritis and in refractory cutaneous lymphoma cancer patients. Sofusa plans to make its first FDA submission as a Class II device delivering biologic therapies intradermally for lymphatic uptake in Q2 2027.

In an open-label, single-arm Phase 1b study (NCT04559412), 10 of 10 patients with moderate-to-severe rheumatoid arthritis who had not improved on the maximum weekly dose (50 mg) of subcutaneous etanercept demonstrated clinically meaningful improvement after switching to lymphatic delivery at half the dose (25 mg) — including a 70% reduction in tender joints, a 34% improvement in DAS28-ESR, and a 62% reduction in pain, with virtually no administration pain (VAS below 5 on a 0–100 scale). In a separate Phase 1b study in cutaneous T-cell lymphoma (CTCL) at City of Hope, two of three patients with advanced disease who had not responded to prior treatments responded to lymphatic delivery of pembrolizumab.

In preclinical biodistribution studies, by delivering biologic therapies directly into the lymphatic system — where key immune targets reside — the platform achieved up to 80-fold higher drug concentrations in lymph nodes compared with conventional subcutaneous administration, with lower concentrations in off-target organs. Because DoseConnect can work with already-approved biologic medicines, the company expects these proven mechanisms to offer a more efficient development pathway, with shorter timelines and lower costs. In addition, the potential for lower doses due to increased lymphatic concentrations may enable better outcomes at lower cost. Novel immunotherapies such as bispecific antibodies or oncolytic virus therapies may also benefit from lymphatic delivery to enhance clinical response and reduce systemic toxicity.

“By enabling clinicians to both visualize and treat the lymphatic system, we aim to reveal biology, improve therapeutic precision, and transform the treatment of immune-mediated diseases,” said Brian Cooley, Chief Executive Officer of Sofusa Holdings. “I returned to Sofusa because I saw patients improve with lymphatic delivery of medicines when nothing else had worked. Seeing what that could mean for patients and their families made the opportunity deeply personal. That is the promise we are building this company around.”

The Sofusa platform was originally developed at Kimberly-Clark and advanced into clinical trials under Sorrento Therapeutics, benefiting from over ~$100M of cumulative investment. New investors acquired the rights and have launched Sofusa as an independent company to bring the platform to commercial reality.

“After more than a decade of innovation and development within large organizations, Sofusa’s science and value proposition are ready to stand on their own,” said Akash Gupta, Chairman of Sofusa Holdings. “The lymphatics are an extensive vascular network central to fluid transport and adaptive immunity, yet historically difficult to observe and access. Sofusa’s platform is designed to access this network directly and deliver therapy directly into it — potentially requiring less drug to achieve more. That’s a fundamentally new approach to medicine with the potential to transform treatment across autoimmune disease, oncology, and many other indications.”

Sofusa will present at the MedTech Strategist Innovation Summit San Diego 2026, held November 3–5 at The US Grant Hotel in San Diego, CA. Chief Executive Officer Brian R. Cooley will present on Wednesday, November 4, 2026, at 11:40 a.m. PT. Members of the Sofusa executive leadership team will be available for one-on-one partnering meetings with strategic partners and biopharmaceutical executives throughout the summit.

About Sofusa Holdings

Sofusa Holdings is a clinical-stage technology platform company developing investigational tools for lymphatic imaging and targeted drug delivery. Its DoseConnect^® platform uses nanotopography-draped microneedles to enable absorption of biologic therapies directly into the lymphatic system. Sofusa’s products are investigational and have not been approved or cleared by the FDA.

Forward-Looking Statements

This press release contains forward-looking statements, including statements about Sofusa’s development and commercialization plans, the potential benefits of its platform, anticipated regulatory submissions and potential collaborations. These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially, including clinical study results, regulatory review, manufacturing, financing and partnering. Sofusa undertakes no obligation to update these statements except as required by law.

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