
Tregalizumab - Leading a New Era of T-cell-Mediated Disease Treatment
At the core of CD4 Therapeutics is our lead asset, Tregalizumab - a highly innovative monoclonal antibody designed to selectively activate regulatory T-cells (Tregs). Tregs are crucial for maintaining immune balance, and Tregalizumab’s ability to restore immune regulation holds the promise to disrupt the current treatment paradigms in dermatology and oncology by addressing severe conditions like oral Lichen Planus (oLP) and acute Graft-vs-Host Disease (aGvHD). Both diseases represent significant global health burdens with limited treatment options. CD4 Therapeutics aims to deliver life-changing therapies to patients who currently have little to no disease-modifying solutions.
What sets Tregalizumab apart is its:
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Proven safety profile, demonstrated across nearly 700 patients.
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Early clinical proof-of-concept, positioning it as a potential game-changer for T-cell mediated disorders.
Our preclinical data strongly support its potential to change the standard of care in two high-impact indications:
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Oral Lichen Planus (oLP) – a lesser-known but highly underserved dermatological condition. Over 3,000,000 moderate-to-severe patients suffer from this pre-cancerous condition. As the only Treg targeting approach with promising efficacy data in dermatology to date, Tregalizumab has the potential to be a 1st in class compound with a disruptive therapeutic profile providing a dual benefit for oLP patients - Disease Control and Cancer Prevention.
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Acute Graft-versus-Host-Disease (aGvHD) – with Orphan Drug Designation from the FDA, aGvHD presents a significant opportunity. Despite recent advancements, there remains a 50% non-responder rate to current therapies, leaving a substantial unmet need. Top KOLs are rallying behind the potential of Tregalizumab to offer a much-needed therapeutic breakthrough.

About CD4 Therapeutics
CD4 Therapeutics GmbH is a cutting-edge biopharmaceutical company founded in 2024 by a team of seasoned industry experts with over 30 years of experience in drug development, clinical research and successfully scaling biotech ventures. Our company is driven by the vision to transform patient care by developing groundbreaking therapies that address significant unmet medical needs in autoimmune and inflammatory diseases. By focusing on high-need indications where current treatment options are limited or nonexistent, CD4 Therapeutics aims to change the treatment landscape and improve the quality of life for millions of patients.
2024 Creation CD4 Therapeutics
2024 UPC patent application for LP filed
2023 Differentiated treatment approach established
2023 Orphan Drug Designation US (GvHD) granted
2022 Pre-clinical evidence in GvHD indicating survival benefit
Prior 2020 Promising early efficacy signals in Psoriasis phase 2a trial
2000 Foundational science and clinical research: safety & tolerability of tregalizumab demonstrated
