Soligenix Advances Novel Photodynamic Therapy for Early-Stage Cutaneous T-Cell Lymphoma

Cutaneous T-cell lymphoma (CTCL) presents significant diagnostic challenges in its early stages, creating a difficult treatment landscape for clinicians and patients. Soligenix Inc. (NASDAQ: SNGX) is advancing a novel therapeutic approach through its development of HyBryte, also known as synthetic hypericin, designed specifically for early-stage CTCL treatment. This visible light-activated photodynamic therapy represents a potential shift from traditional ultraviolet-based phototherapies that carry long-term safety risks with cumulative exposure.

HyBryte operates through activation by visible light in the red-yellow spectrum, allowing targeted treatment of malignant T-cells in the skin while minimizing damage to surrounding healthy tissue. Clinical data reported by Soligenix indicate that HyBryte has demonstrated statistically significant efficacy in reducing CTCL lesions in patients with early-stage disease. The company’s Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of this therapy, with regulatory approvals being sought worldwide following successful completion of the second Phase 3 study.

The development of HyBryte addresses critical gaps in rare disease treatment where unmet medical needs exist. Beyond CTCL, Soligenix is expanding synthetic hypericin development into psoriasis treatment under the designation SGX302. The company’s broader portfolio includes first-in-class innate defense regulator technology, dusquetide (SGX942) for inflammatory diseases including oral mucositis in head and neck cancer, and SGX945 for Behçet’s disease. Additional information about the company’s research and development efforts can be found at https://www.Soligenix.com.

Soligenix’s Public Health Solutions business segment includes vaccine development programs incorporating proprietary heat stabilization platform technology known as ThermoVax®. These programs target ricin toxin, filoviruses such as Marburg and Ebola, and CiVax for COVID-19 prevention. This segment has received government support through grants and contracts from agencies including the National Institute of Allergy and Infectious Diseases, the Defense Threat Reduction Agency, and the Biomedical Advanced Research and Development Authority. The company’s ongoing research represents a multifaceted approach to addressing both rare diseases and public health threats through innovative therapeutic and vaccine technologies.

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