Soligenix to Present New HyBryte Data for Cutaneous T-Cell Lymphoma Treatment at USCLC Workshop

Soligenix announced that new supportive trial data for HyBryte in the treatment of cutaneous T-cell lymphoma will be presented at the United States Cutaneous Lymphoma Consortium Workshop on March 26, 2026, ahead of the American Academy of Dermatology Annual Meeting. The presentations will highlight positive results from a long-term treatment study and a comparative analysis versus Valchlor, supporting HyBryte potential as a therapeutic option for CTCL. This development is significant as it represents progress for a novel photodynamic therapy utilizing safe visible light for a rare disease with unmet medical needs.

The company's Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte, also known as SGX301 or synthetic hypericin sodium. With successful completion of the second Phase 3 study, regulatory approvals will be sought to support potential commercialization worldwide. The data presentation at the upcoming workshop provides an important platform for sharing clinical evidence with the medical community, potentially influencing treatment approaches for cutaneous T-cell lymphoma patients.

Development programs in this business segment also include expansion of synthetic hypericin into psoriasis, first-in-class innate defense regulator technology, dusquetide for the treatment of inflammatory diseases including oral mucositis in head and neck cancer, and SGX945 in Behcet's Disease. The company's broader pipeline indicates a strategic focus on addressing specialized therapeutic areas where existing options may be limited.

Soligenix's Public Health Solutions business segment includes development programs for RiVax, the company's ricin toxin vaccine candidate, as well as vaccine programs targeting filoviruses such as Marburg and Ebola and CiVax, a vaccine candidate for the prevention of COVID-19. The development of these vaccine programs incorporates the use of proprietary heat stabilization platform technology known as ThermoVax. This business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases, the Defense Threat Reduction Agency, and the Biomedical Advanced Research and Development Authority.

The presentation of HyBryte data at the USCLC workshop represents a critical step in the therapy's development pathway, potentially bringing this treatment option closer to patients with cutaneous T-cell lymphoma. As the company seeks regulatory approvals following successful Phase 3 studies, the medical community's reception of this new data could influence both clinical practice and regulatory decision-making. The comparative analysis against Valchlor is particularly noteworthy as it provides direct evidence of HyBryte's potential advantages or differentiation in the treatment landscape.