Soligenix Inc. (NASDAQ: SNGX) Builds Momentum in Fight Against Rare, Chronic Cancer

• Although CTCL may progress slowly in its early stages, it remains a chronic and ultimately progressive disease for many patients.
• Front-line therapies for CTCL remain limited and fragmented.
• Soligenix is advancing a distinct approach to CTCL treatment through the development of HyBryte(TM), also known as SGX301 or synthetic hypericin.

Cutaneous T-cell lymphoma (“CTCL”) remains a cancer with limited treatment options, persistent symptoms and long-term quality-of-life challenges for patients, even decades after its classification as a distinct disease. Despite medical advances in oncology, many people living with CTCL continue to cycle through therapies that offer only partial relief or introduce new burdens. Soligenix (NASDAQ: SNGX) is advancing new treatment approaches focused on improving tolerability and long-term quality of life for patients living with this rare cancer.

CTCL is a rare form of non-Hodgkin lymphoma that primarily affects the skin, most commonly presenting as mycosis fungoides and Sézary syndrome. It is classified as a chronic, often indolent malignancy that can persist for years or decades, with symptoms that include persistent rashes, plaques, tumors, intense itching and skin pain. According to Soligenix, CTCL accounts for approximately 6% of all non-Hodgkin lymphomas, and its early stages frequently resemble benign skin conditions, which can complicate diagnosis and delay appropriate treatment. 

Although CTCL may progress slowly in its early stages, it remains a chronic and ultimately progressive disease for many patients. The Cutaneous Lymphoma Foundation notes that CTCL is not considered curable with current therapies and that treatment typically focuses on disease control, symptom relief and preservation of quality of life rather than cure. Early-stage disease is often managed with skin-directed therapies, while advanced disease frequently requires systemic treatments that can carry significant toxicity. This long-term disease course means patients often undergo multiple treatment regimens over their lifetime, with cumulative physical and psychological burdens. 

Front-line therapies for CTCL remain limited and fragmented. Standard options include topical corticosteroids, phototherapy, retinoids, interferons, chemotherapy and biologic agents, but response durability is often variable. One review highlights that many CTCL therapies offer only temporary disease control and that relapse is common, reinforcing the need for better tolerated, long-term treatment strategies. The same review emphasizes that balancing disease control with quality of life remains a central challenge in CTCL management.

These limitations are compounded by the fact that many systemic therapies used in later-stage disease can cause immunosuppression, fatigue, organ toxicity and infection risk, creating difficult tradeoffs between disease control and patient well-being. The European Society for Medical Oncology has similarly noted that CTCL remains an area of unmet medical need, particularly for therapies that can be safely used over long periods without cumulative harm. 

Against this backdrop, Soligenix is advancing a distinct approach to CTCL treatment through the development of HyBryte(TM), also known as SGX301 or synthetic hypericin. HyBryte is a visible light-activated photodynamic therapy designed specifically for early-stage CTCL. Unlike ultraviolet-based phototherapies, which can carry long-term carcinogenic risk with repeated exposure, HyBryte uses visible light in the red-yellow spectrum to activate the therapeutic compound in the skin, targeting malignant T-cells while minimizing damage to surrounding healthy tissue. 

HyBryte’s nonsystemic design directly addresses many of the tolerability and quality-of-life limitations associated with current CTCL therapies. Because the therapy is applied topically and activated locally, it avoids any meaningful systemic drug exposure that can lead to widespread side effects. Soligenix explains that this localized mechanism is intended to reduce cumulative toxicity and allow for long-term disease management without the risks associated with chronic systemic immunosuppression. 

Clinical data support the potential of this approach. “In the phase 3 FLASH study, HyBryte was shown to be efficacious in early-stage CTCL with a promising safety profile,” said Ellen Kim, MD, director of the Penn Cutaneous Lymphoma Program and lead investigator of the HyBryte FLASH2 study. “CTCL patients are often searching for alternative treatments, with limited options especially for early-stage disease. HyBryte offers a distinct treatment option which patients found extremely useful and continue to specifically request. We look forward to demonstrating the expanded positive impact of the use of HyBryte in a more ‘real-world’ setting.”

HyBryte therapy has received orphan drug and fast track designations from the U.S. Food and Drug Administration, orphan drug designation in Europe and a Promising Innovative Medicine designation from the UK Health Authority, reflecting regulatory recognition of its potential clinical value for a rare cancer with limited treatment alternatives. 

Soligenix’s strategy reflects a broader shift in CTCL care toward therapies that prioritize long-term disease control, tolerability and patient quality of life rather than short-term symptom suppression alone. By focusing on a nonsystemic, skin-directed approach, the company aims to provide patients with a treatment option that can be used safely over extended periods, addressing the chronic nature of the disease rather than treating it as an episodic condition.

This focus is especially relevant given the long diagnostic delays and prolonged treatment journeys many CTCL patients experience. As institutions and leading oncology organizations continue to raise awareness about CTCL misdiagnosis and delayed care, the availability of better tolerated therapies becomes increasingly important for patients who may spend years navigating ineffective or burdensome treatments.

CTCL remains a cancer defined not only by its rarity but by the long-term challenges it imposes on patients’ lives. The absence of curative therapies, the need for chronic disease management and the limitations of existing treatments continue to create a strong case for innovation. Soligenix’s work with HyBryte reflects an effort to move beyond incremental improvements toward therapies designed specifically around patient tolerability, quality of life and long-term usability. As the CTCL treatment landscape evolves, approaches that balance efficacy with safety and sustainability may play a critical role in shaping future standards of care for this underserved patient population.

For more information, visit www.Soligenix.com.

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