Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there are unmet medical needs.
Soligenix has specialized expertise in the development of orphan and unmet medical need indications – including the regulatory nuances (Orphan Drug designation, Fast Track designation, use of adaptive trial designs etc.) and clinical execution (specialized recruitment approaches, direct site interactions etc.). Soligenix directly conducts all of its Phase 2 and 3 clinical studies, being in personal contact with the sites and principal investigators, ensuring the highest data quality while streamlining timelines and budgets.
By working in indications where treatment is lacking and populations are specialized, Soligenix has an outsized impact on patient outcomes and quality of life.
The regulatory commonalities between all indications in rare disease/unmet medical need means that Soligenix expertise can be impactful across a variety of diseases:
What is an orphan / rare disease?
According to the FDA, an orphan disease affects less than 200,000 people nationwide. Other jurisdictions have similar definitions. With the smaller patient populations involved, regulatory agencies often have Orphan Drug designations that recognize the unique requirements of clinical trials in these populations.
Orphan / Rare Disease Market
About 20,000 patients in the US have cutaneous T-cell lymphoma and while the disease is not usually fatal, medical management of the lesions remains challenging.
Cancer Supportive Care
Radiation and chemotherapy are a necessary part of cancer treatment but the treatments have their own side effects because they kill healthy cells as well as tumor cells, and because the body launches an inflammatory response, partly to attempt to heal the damage.
Oral mucositis is a very common condition across a range of cancer treatment regimens. This debilitating side effect is particularly prevalent in head and neck cancer patients. Severe oral mucositis not only increases the probability of a patient experiencing dehydration and malnutrition but also increases the likelihood of additional hospital admission and potentially life-threatening infections.
Acute radiation enteritis is the result of radiation damage to the intestine, followed by an aberrant healing process with excessive inflammation. This condition both decreases the quality of life for patients and in severe cases, can be life-threatening. It occurs primarily in patients receiving radiation to the pelvic or abdominal area.
Aberrant inflammatory processes also occur in the gastrointestinal tract due to either over-enhanced immune responses or environmental or genetic factors, alone or in combination.
Pediatric Crohn’s Disease is an example of an inflammatory bowel disease which is both severe and difficult to treat. There is currently no approved front line therapy for pediatric Crohn’s disease and the off-label use of prednisone, while the best available at the moment, can make many of the underlying issues with Crohn’s disease worse (e.g., delayed growth).
In the biodefense context, ricin toxin is a Category B biothreat and Soligenix is using its proprietary thermal stabilization technology, ThermoVax®, to advance its world-leading ricin toxin vaccine. This same technology is also relevant to other vaccines for global use, and Soligenix is currently collaborating on vaccines for filoviruses (e.g., Ebola and Marburg) and for coronavirus (e.g, COVID-19).
Finally in the public health sphere, the rise of antibiotic resistant infections and the threat of emerging bacterial infectious disease also threaten to undue years of progress since the discovery of antibiotics in the 1930s. Soligenix is applying its Innate Defense Regulator technology from its oral mucositis program to this problem as well and is seeking further government funding to advance this program.
Scientific Advisory Boards
Soligenix cares deeply and works tirelessly to improve the lives of patients worldwide. Our Scientific Advisory Boards for each area of focus have decades of experience in the biopharmaceutical industry, which includes unique expertise in developing orphan / rare disease therapies.