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By Kyle Anthony, Benzinga
Soligenix, Inc. (NASDAQ: SNGX), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases and areas of unmet medical need, has a portfolio of products aimed at treating orphan diseases. The United States (U.S.) Food and Drug Administration (FDA) defines an orphan disease as a rare disease or condition that affects fewer than 200,000 people in the U.S.. By focusing primarily on rare diseases, Soligenix can address the needs of niche but critical markets while having a long-lasting impact on patients' outcomes and quality of life.
Soligenix’s Areas Of Focus
Soligenix has a dual market focus: Specialized Biotherapeutics and Public Health Solutions. The firm’s Specialized Biotherapeutics division is dedicated to developing products for orphan diseases and areas of unmet medical need, such as Cutaneous T-cell lymphoma (CTCL), Psoriasis, Oral Mucositis and Behçet’s disease. This segment is where much of the firm’s product development focus and initiatives reside.
The firm’s Public Health Solutions division seeks to develop heat stable vaccines and therapeutics for military and civilian applications in the areas of ricin exposure and viral diseases including Ebola and Marburg. This division has been funded almost entirely by the U.S. Government with grant and contract awards, with this non-dilutive funding exceeding $60 million to date.
Soligenix’s Product Pipeline
Soligenix’s Specialized Biotherapeutics division has several product offerings in different phases of development. Their lead product candidate, HyBryte™, is in final clinical testing and is a promising treatment for CTCL. CTCL is a rare, chronic and treatable type of non-Hodgkin’s lymphoma affecting the skin and is caused by a mutation in T-cells, which are white blood cells that help fight infection. The mutated T-cells attack the skin, causing lesions to appear. As reported by the Cutaneous Lymphoma Foundation, approximately 3,000 new cases are reported in the U.S. every year, with as many as 20,000-30,000 living with this chronic, incurable disease. CTCL is more common in men than women and in patients older than 50, compared to younger people. By 70 years old, there is a four-fold increase in CTCL cases.
HyBryte is a photodynamic therapy that uses synthetically manufactured hypericin in an ointment or gel combined with safe, visible fluorescent or LED light. Photodynamic light therapy is a two-part treatment. First, the drug (synthetic hypericin) is applied topically to the skin. Then, it is activated by visible light. Soligenix reports that synthetic hypericin, the active ingredient in HyBryte, tends to accumulate in T-cells. Once the hypericin is in the T-cells, it can be activated by safe, visible light. When synthetic hypericin is activated, it creates oxygen radicals, which subsequently cause cellular toxicity, killing the targeted T-cells, reports Soligenix.
Soligenix says that HyBryte has demonstrated positive and statistically significant results in phase 1, 2 and 3 clinical studies. To further advance their clinical findings, the company recently announced the formation of a European Medical Advisory Board to provide additional clinical guidance on the safety and efficacy of HyBryte, and will be initiating a second confirmatory phase 3 trial in 80 CTCL patients before year end to support potential marketing approval worldwide. HyBryte has orphan drug designations in the U.S. and Europe, as well as a Fast Track designation for treating CTCL in the U.S. and a Promising Innovative Medicine designation from the United Kingdom Medicines and Healthcare Products Regulatory Agency.
Soligenix has another product offering, SGX302, that also utilizes photodynamic light therapy and synthetic hypericin to treat mild-to-moderate psoriasis. Psoriasis is a chronic skin condition in which inflammation, exacerbated by T-cells of the adaptive immune system (autoimmune response), causes itchy and sometimes painful rashes and lesions. The lesions develop because the skin cells grow and divide rapidly. According to the National Psoriasis Foundation, more than 8 million people in the U.S. have this incurable disease.
Clinical studies with SGX302 have found it safe and efficacious in treating the disease, reports Soligenix. Regarding the success of their clinical studies and the learnings gathered, Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix, has stated, “We are pleased with the preliminary findings from our ongoing Phase 2a trial. Current estimates show as many as 60-125 million people worldwide living with the condition, with a global treatment market valued at approximately $15 billion in 2020 and projected to reach as much as $40 billion by 2027. The success of HyBryte™ in targeting malignant T-cells during CTCL clinical trials is a promising indicator of the ability of SGX302 to provide a much-needed approach for the treatment of mild-to-moderate psoriasis, also caused by dysregulated T-cells.”
Soligenix is also developing a treatment for oral mucositis. Mucositis is the damage done to the lining of the mouth and gut by cancer treatment regimens. Severe oral mucositis (SOM) occurs when the damage to the mouth is so severe that a patient’s ability to eat and drink is compromised, adversely affecting their nutrition and immune system.
Soligenix’s SGX942 (dusquetide) is an intravenous formulation of the Innate Defense Regulator (IDR), dusquetide, for treating SOM. IDRs are a new compound class that changes the innate immune system's response by decreasing inflammation and increasing anti-infective and tissue healing activities. Dusquetide, as described by Soligenix, is a drug composed of 5 amino acids, naturally occurring molecules that make up the proteins in your body. As such, the metabolism of dusquetide results in additional building blocks for your body and does not interfere with any other drugs you may be taking.
Soligenix reports that SGX942 has demonstrated safety in a phase 1 clinical study in 84 healthy volunteers, and biological activity and preliminary efficacy in phase 2 and 3 placebo-controlled clinical studies. SGX942 has a Fast Track designation for treating oral mucositis in the U.S. and a Promising Innovative Medicine designation from the United Kingdom Medicines and Healthcare Products Regulatory Agency.
Soligenix’s other specialized biotherapeutics include a product for treating Behçet’s Disease, a rare autoimmune disease, which is characterized by recurring oral and genital lesions. The company’s candidate for Behçet’s Disease, SGX945 (containing dusquetide, the same active in SGX942), is also currently enrolling patients in a phase 2 clinical trial, and topline results for both SGX945 and SGX302 trials are expected in H1 2025.
Regarding their Public Health Solutions, Soligenix’s RiVax® is a safe alum-adjuvanted subunit vaccine candidate that may prevent death and injury from exposure to ricin toxin, a lethal yet easily manufactured white powder that can induce irreversible symptoms within four hours of exposure and may cause death within 48-72 hours.
With the rise in antibiotic-resistant bacteria, Soligenix’s SGX943 is an investigational, intravenous formulation of the Innate Defense Regulator, dusquetide, for treating antibiotic-resistant bacteria and infectious diseases. SGX943 contains the same active ingredient and formulation as SGX942; it is a rapid 4-minute injection that may be administered upon suspicion of bacterial-origin infection before any confirmatory testing and may be given in combination with antibiotics. Treatment is continued every 2-3 days until the infection is resolved.
Finally, ThermoVax® is Soligenix’s proprietary vaccine heat stabilization platform technology for preparing vaccines composed of protein and adjuvant such that they can be lyophilized (freeze-dried) while maintaining optimal potency when stored at elevated temperatures exceeding 100 degrees Fahrenheit. This technology has been applied not only to the company’s ricin vaccine (RiVax®) but also to candidate vaccines for hemorrhagic diseases such as Ebola and Marburg.
Soligenix’s Market Perspective
Though Soligenix’s business model is focused on treating rare diseases, this does not necessarily mean they’re not looking at a large addressable market. As cited by the CEO’s previous quote in this article, the estimated value of psoriasis’s total addressable market will reach approximately $40 billion by 2027. According to Maximize Market Research, the CTCL market was valued at $3.26 billion in 2023 and is expected to grow by 4.8 % from 2024 to 2030, reaching nearly $4.53 billion. Additionally, as reported by Allied Market Research, the global antimicrobial resistance market is projected to reach $9.5 billion by 2032, growing at a compound annual growth rate of 7.6% from 2023 to 2032. Soligenix operates in potentially lucrative pharmaceutical business areas with the possibility of material payoffs for the company.
In the public health realm, Soligenix has received over $60 million in non-dilutive government funding to date. The commercialization of Soligenix's public health offerings opens them up to clients such as the U.S. Government and other economies, where they can supply vaccines via government procurement contracts. Alternatively, given Soligenix’s focus on treating biothreats and emerging infectious diseases, the potential for priority review voucher (PRV) awards from the FDA with marketing approval offers an alternative revenue stream. Their recent investor relations deck noted that they have the potential to receive up to three PRVs with FDA approval, with the last PRV being sold for in excess of $100 million.
Looking Ahead
Soligenix’s focus on developing and commercializing products to treat rare diseases in areas of unmet medical need is aimed at developing a distinct value proposition within the marketplace that is not easily replicable over time. The firm's dual focus enables it to have better optionality within its product shelf, broadening its customer base and diversifying its revenue mix over time.
As the firm embarks on its product development initiatives and seeks further collaboration with biotech firms, academic partners and government agencies, new opportunities for sustainable growth have the potential to emerge.
For more information on Soligenix’s recent stock performance, click here.
Featured photo by Louis Reed on Unsplash.
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