Soligenix (SNGX)

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.

A copy of a 9 page corporate investment profile is available on request. To apply to receive the report, please email Elena Pierce at

Recent Posts on Soligenix

INTERVIEW: Soligenix CEO Christopher Schaber PhD. Dr. Christopher Schaber, President and CEO of Soligenix, a company developing drug therapies in rare diseases and areas of unmet medical need, including a treatment for oral mucositis in head and neck cancer patients. Chris, your drug, Dusquetide or SGX942, sounds like a tremendous development. Can you tell us more…
Soligenix and the Creation of Rare Cancer Drugs Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is currently an unmet medical need. Soligenix is a biotherapeutic business segment dedicated to the development of products for orphan diseases and areas where there are currently no drug therapies approved, such…
Soligenix to Present at the 2017 Biotech and Money Showcase Conference Soligenix, Inc. (Nasdaq: SNGX), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, recently announced that its President and Chief Executive Officer, Christopher J. Schaber, PhD, is to deliver a corporate presentation at the 2017 Biotech & Money…
Soligenix Initiates Phase 3 Trial of Dusquetide for Oral Mucositis in Head & Neck Cancer Patients Soligenix’s self-described “DOM–INNATE” study has initiated patient enrollment. The late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced that patient enrollment has been opened for its Phase 3, multinational, randomized, double-blind, placebo-controlled study evaluating SGX942 (dusquetide) as a…
Dr. Christopher Schaber – President and CEO of Soligenix   Dr. Christopher Schaber is the President and CEO of Soligenix, a late stage biopharmaceutical company with a pipeline of pharmaceutical products to treat a variety of rare diseases with an unmet need. Brett Johnson speaks with Dr. Schaber to discuss Soligenix’s mature pipeline of products, their business in biodefense,…