Chris Schaber is Focused on Rare and Orphan Diseases with High Unmet Medical Need
We recently spoke to Dr. Chris Schaber, President & CEO, Soligenix, Inc. on OncologyTube. Soligenix (Nasdaq: SNGX) is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need.
Dr. Schaber is extremely optimistic about the future of medicine and the progress he and his team are making with the Soligenix drug pipeline – especially their lead product called HyBryte™ for a devastating blood and skin cancer.
HyBryteâ„¢ (SGX301 or synthetic hypericin) is a unique drug that is activated by exposure to light (photodynamic therapy) for the treatment of early-stages of a rare skin cancer called cutaneous T-cell lymphoma (CTCL). Patients with early-stage disease compose the largest proportion of this disease and often remain in this category for many years before progressing. Soligenix has completed all the necessary phases of clinical research for HyBryteâ„¢ and is now in the final stages preparing to file the drug with the Food and Drug Administration (FDA) for review.
HyBryte™ has received Orphan Drug and Fast Track designations from the FDA. Additionally, HyBryte™ has been granted several additional beneficial designations including Orphan Drug designation and a Pediatric Investigation Plan (PIP) waiver (European Medicines Agency- EMA), a PIP product-specific waiver as well as in the U.K., Promising Innovative Medicine designation from the Medicines and Healthcare products Regulatory Agency (MHRA), and more recently, was awarded an “Innovation Passport†for treatment of early-stage CTCL under the Innovative Licensing and Access Pathway (ILAP). Additionally, Soligenix is exploring indications which will maximize the utility of HyBryte™, including large-market skin conditions such as psoriasis.
Soligenix also has a first-in-class drug called dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer (HNC). A phase 3 clinical study is planned for dusquetide in oral mucositis in HNC, and potential anti-cancer efficacy. Another pipeline drug called beclomethasone 17,21-dipropionate (BDP) is in development for the prevention/treatment of gastrointestinal (GI) disorders including pediatric Crohn’s disease.
Dr. Schaber noted additional Soligenix R&D work including their heat stable vaccine platform technology which include vaccine candidates targeting Ebola, Sudan, and Marburg Viruses. Soligenix is also exploring a novel heat stable COVID-19 vaccine candidate, CiVax™, and a ricin toxin vaccine, RiVax®.
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Dr. Schaber outlined the company’s financial performance, which includes $29 million in cash reported in the company’s Form 10-Q for the quarter ended September 30, 2021, not including their non-dilutive government funding. Soligenix is sufficiently capitalized to achieve multiple key milestones across their rare disease pipeline, especially moving towards NDA and commercialization of HyBryte™. Specific plans for commercialization, including work with their HyBryte™ light source partner, Daavlin Co. a phototherapy leader, are now underway.