Mature pipeline of biopharmaceuticals for rare diseases. Government funding for biodefense business.
Soligenix is a two-segment business. They have a biotherapeutics rare disease segment focused on cancer, cancer supportive care and inflammation and a separate vaccine/biodefense segment of business funded entirely by the U.S. government, focused on medical countermeasures for military and civilian use.
Soligenix’s biotherapeutics pipeline is robust with a focus in rare diseases. There are three main therapies in their pipeline.
(1) SGX301 for cutaneous T-Cell Lymphoma (CTCL): synthetic hypericin activated by fluorescent light. Efficacy/safety demonstrated in Phase 2 study; pivotal Phase 3 study enrolling with blinded interim analysis completed in Q4 2018 and topline results expected in Q1 2020. Preclinical and clinical data for SGX301 has also indicated possible utility for psoriasis treatment.
(2) SGX942 (dusquetide) for oral mucositis: a novel synthetic, 5-amino acid peptide, with high aqueous solubility and stability that targets the innate immune system to modulate the body’s own defenses. Efficacy/safety demonstrated in a Phase 2 study; pivotal Phase 3 study actively enrolling in the US and Europe with blinded interim analysis expected to be completed in September 2019 and topline results in 1H 2020, pending results of the interim analysis. Preclinical and clinical data has also indicated possible utility in emerging and antibiotic resistant infectious disease. China partnership with SciClone Pharmaceuticals, Inc.
(3) SGX203 for pediatric Crohn’s disease: a proprietary oral reformulation of a known steroid (beclomethasone dipropionate) targeting the upper and lower GI tract. Efficacy/safety demonstrated in related indications with a pivotal Phase 3 protocol ready to proceed pending partnership/financial support. Also has potential utility in acute radiation enteritis.
In the US, there are currently 20,000 cases of CTCL a year with 3,000 more each year. There is no cure for CTCL, and with most current treatments for the lesions, the lesions recur. If caught in the early stages (mycosis fungiodes), the patient can live for years beyond the diagnosis. However, there is no approved front line therapy for CTCL and all other therapies for more advanced disease have significant toxicity. Soligenix’s SGX301 could be the first FDA approved photodynamic therapy for CTCL and has a significant safety advantage. SGX301 has received orphan and fast yrack designations. Approximately 90,000 people are affected by head and neck cancer in the US, it is an area of unmet need and therefore Soligenix received FDA fast track for SGX942.
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