Soligenix Summary

By  USDR

Soligenix, Inc. is a late-stage biopharmaceutical company committed to developing and commercializing products that treat rare diseases where there is an unmet medical need. Soligenix supports a robust pipeline of innovative drug candidates through two business segments: a BioTherapeutics segment and a Vaccines/Biodefense segment. The company has an experienced management team and Board of Directors, as well as a broad portfolio of product candidates. Soligenix has multiple orphan disease and fast-track development programs with significant market  potential.

Through the BioTherapeutics segment, Soligenix develops products for orphan diseases such as cutaneous T-cell lymphoma, oral mucositis, pediatric Crohn’s disease and acute radiation enteritis. This includes a pivotal Phase 3 clinical program of SGX203 (oral beclomethasone dipropionate), for the treatment of pediatric Crohn’s disease, as well as the pivotal Phase 3 program of SGX301 (synthetic hypericin), for cutaneous T-cell lymphoma, which has recently initiated  enrollment.

Both compounds have been granted orphan drug and fast track designations from the US Food and Drug Administration  (FDA).

In addition, positive preliminary results were recently reported in the Company’s Phase 2 proof-of-concept trial in oral mucositis with SGX942 (dusquetide), a novel, first-in-class innate defense regulator (IDR). SGX942 modulates the body’s reaction to both injury and infection towards an anti-inflammatory and an anti-infective response. The Phase 2 preliminary results reported by Soligenix showed a clinically meaningful reduction in the duration of severe oral mucositis in patients receiving chemoradiation therapy for treatment of their head and neck  cancer.

Through the Vaccines/Biodefense business segment, Soligenix develops vaccines and therapeutics for military and civilian applications in the areas of ricin exposure with RiVax™, gastrointestinal acute radiation syndrome with OrbeShield® and melioidosis with SGX943. The segment is currently supported with up to $57 million in government contract funding from the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development  Authority.

These three compounds have also been granted orphan drug and/or fast track designations from the US Food and Drug Administration  (FDA).

The cornerstone of the vaccine segment is the ThermoVax® technology, a proprietary heat stabilization technology. This technology, in which a liquid vaccine can be dried out to a powder and stored at elevated temperatures, has the potential to facilitate easier storage and distribution of strategic national stockpile vaccines in emergency  settings.

There is significant market opportunity for Soligenix’s biotherapeutics and vaccine/biodefense business segments. The company has a robust and diversified pipeline with late-stage assets that aim to rise to the challenge of rare disease treatment. Soligenix additionally has multiple potential value drivers over the next 12 to 24 months that will build significant value for investors. Just as important, the company has an experienced and dedicated management team that is committed to aggressively moving this important pipeline forward to potential  success.

All opinions expressed on USDR are those of the author and not necessarily those of US Daily Review.