Learn Why Soligenix has Received $60M+ in Non-Dilutive Funding From the US Government: CEO Interview
Aug. 6, 2024
Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. The Company's primary focus is on its Specialized BioTherapeutics business segment, which is responsible for the development of HyBryte™ (synthetic hypericin), a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). The Company has successfully completed a Phase 3 study for HyBryte™ and has reached agreement with the European Medicines Agency (EMA) on the key design components of a confirmatory Phase 3 pivotal study while discussions with the US Food & Drug Administration remain ongoing.
Additionally, Soligenix has expanded the clinical evaluation of synthetic hypericin (SGX302) into psoriasis, as well as developing proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention and treatment of gastrointestinal (GI) disorders characterized by severe inflammation. The Company is also developing a first-in-class innate defense regulator (IDR) technology, dusquetide, to treat inflammatory diseases, including oral mucositis in head and neck cancer (SGX942) and Behçet's disease (SGX945). Soligenix received FDA IND clearance in Q4 2023 for a Phase 2 trial of SGX945 (dusquetide) for the treatment of aphthous ulcers in Behçet's disease and “Fast Track” designation from the FDA in January 2024.
Soligenix's Public Health Solutions business segment is responsible for the development of a number of exciting new products designed to combat a variety of severe medical conditions, including RiVax®, a ricin toxin vaccine candidate that will combat ricin poisoning, as well as vaccine programs focused on filoviruses, including Ebola (SuVax™) and Marburg (MarVax™), each of which were granted Orphan designation by the FDA in April 2024. The Company is also working on a promising vaccine candidate for the prevention of COVID-19. Soligenix is utilizing a proprietary heat stabilization platform called ThermoVax® to develop its vaccine products. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA), and the Biomedical Advanced Research and Development Authority (BARDA).
