Soligenix HyBryte Clinical Data Published in Peer-Reviewed Journal, Supporting Potential as First-Line CTCL Treatment

Soligenix Inc. announced that a comprehensive summary of clinical trials evaluating HyBryte for cutaneous T-cell lymphoma has been published in the peer-reviewed journal Expert Opinion on Investigational Drugs. The publication highlights the therapy's safety profile, non-mutagenic mechanism and demonstrated efficacy across studies, while supporting its potential as a first-line treatment option. This peer-reviewed validation comes as the company advances its ongoing FLASH2 Phase 3 trial with interim analysis expected in the second quarter of 2026.

The publication's significance lies in its comprehensive analysis of HyBryte's clinical data, which provides independent scientific validation of the therapy's profile. Cutaneous T-cell lymphoma represents a significant unmet medical need, with current treatments often carrying substantial side effects or limited efficacy. HyBryte's non-mutagenic mechanism represents a potentially safer alternative to existing therapies that may carry carcinogenic risks. The therapy utilizes synthetic hypericin as a photodynamic treatment activated by safe visible light, distinguishing it from other approaches in the field.

Soligenix's Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte as a novel photodynamic therapy for cutaneous T-cell lymphoma. With successful completion of the second Phase 3 study, regulatory approvals will be sought to support potential commercialization worldwide. The company's development programs in this business segment also include expansion of synthetic hypericin into psoriasis, as well as first-in-class innate defense regulator technology for inflammatory diseases including oral mucositis in head and neck cancer and Behçet's Disease.

The company's Public Health Solutions business segment includes development programs for RiVax, its ricin toxin vaccine candidate, as well as vaccine programs targeting filoviruses such as Marburg and Ebola and CiVax for COVID-19 prevention. 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 development of these vaccine programs incorporates the company's proprietary heat stabilization platform technology known as ThermoVax.

The peer-reviewed publication of HyBryte's clinical data represents a significant milestone in the therapy's development pathway. As the company progresses toward its Phase 3 interim analysis in 2026, this published data provides the scientific community and potential regulatory bodies with comprehensive evidence supporting the therapy's safety and efficacy profile. For patients with cutaneous T-cell lymphoma, the development of HyBryte represents a potential advancement in treatment options that could offer improved safety characteristics compared to existing therapies while maintaining therapeutic effectiveness.