Soligenix CEO Discusses Phase 3 HyBryte Progress and Key Milestones on BioMedWire Podcast

Soligenix Inc., a late-stage biopharmaceutical company focused on rare diseases, was featured in the latest BioMedWire Podcast episode where CEO Christopher Schaber discussed the upcoming interim analysis of the Phase 3 FLASH2 study evaluating HyBryte for cutaneous T-cell lymphoma. Schaber noted strong blinded aggregate response rates above initial assumptions and outlined potential outcomes including early study completion or continued enrollment. He emphasized upcoming interim and top-line data as potentially transformational milestones supporting commercialization and partnership opportunities.

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 a treatment for Behçet's Disease.

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, the company's vaccine candidate for the prevention of COVID-19. The development of these vaccine programs incorporates the use of the company's 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 progress in the Phase 3 FLASH2 study represents a significant development for patients with cutaneous T-cell lymphoma, a rare disease with limited treatment options. The strong blinded aggregate response rates noted by Schaber suggest the therapy may be more effective than initially anticipated, potentially leading to earlier regulatory submissions and patient access. The company's broader pipeline addressing multiple rare diseases and public health threats demonstrates its strategic focus on areas of significant unmet medical need. Additional information about the company is available through its newsroom at https://ibn.fm/SNGX.

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