Soligenix Advances HyBryte Therapy for Early-Stage Cutaneous T-Cell Lymphoma

Soligenix Inc. is advancing a novel therapeutic approach for cutaneous T-cell lymphoma through its development of HyBryte, also known as synthetic hypericin. Cutaneous T-cell lymphoma is recognized by clinicians as one of the most difficult cancers to diagnose accurately in its early stages. Within a challenging diagnostic and treatment landscape, HyBryte represents a visible light-activated photodynamic therapy designed for the treatment of early-stage CTCL. Unlike traditional ultraviolet-based phototherapies, which can carry long-term safety risks with cumulative exposure, HyBryte is activated by visible light in the red-yellow spectrum. This mechanism allows for 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 HyBryte as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma. With successful completion of the second Phase 3 study, regulatory approvals will be sought to support potential commercialization worldwide. Development programs in this business segment also include expansion of synthetic hypericin into psoriasis, the company's first-in-class innate defense regulator technology, dusquetide for the treatment of inflammatory diseases including oral mucositis in head and neck cancer, and another candidate in Behçet's disease.

The company's Public Health Solutions business segment includes development programs for RiVax, its ricin toxin vaccine candidate, as well as its vaccine programs targeting filoviruses such as Marburg and Ebola and CiVax, the company's vaccine candidate for the prevention of COVID-19. The development of Soligenix's vaccine programs incorporates the use of its proprietary heat stabilization platform technology known as ThermoVax. This business segment has been supported with government grants 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. For further information about the company's broader initiatives, visit their official website.

The advancement of HyBryte matters because it addresses critical gaps in the treatment of a rare disease where existing therapies have limitations. Traditional phototherapies using ultraviolet light pose long-term safety concerns due to cumulative exposure risks, including potential damage to healthy skin cells and increased cancer risk. HyBryte's visible light activation offers a more targeted approach that could provide effective treatment while reducing these safety concerns. For patients with early-stage CTCL, who often face diagnostic challenges and limited treatment options, this therapy represents a potential advancement in care. The statistically significant efficacy data reported by Soligenix suggests HyBryte could become an important therapeutic option if approved, potentially improving outcomes for patients with this difficult-to-treat cancer.