- One of the key advantages of photodynamic therapy is its selectivity.
- Soligenix is advancing HyBryte(TM), or SGX301, designed for the treatment of cutaneous T-cell lymphoma.
- The company has achieved an important safety milestone in its confirmatory phase 3 clinical trial of HyBryte for CTCL treatment.
From lab research to clinical application, photodynamic therapy (“PDT”) is emerging as a powerful treatment approach that uses light and chemistry to selectively target diseased tissue. As this modality gains attention for its precision and safety profile, Soligenix (NASDAQ: SNGX) is developing light-activated therapies designed to treat cutaneous T-cell lymphoma (“CTCL”) and other inflammatory skin diseases using targeted photodynamic mechanisms that aim to improve outcomes while minimizing systemic toxicity.
“Cancer therapy, especially for tumors near sensitive areas, demands precise treatment,” states a Frontier report on PDT, a treatment method leveraging photosensitizers (“PS”), specific wavelength light and oxygen to target cancer effectively. “Recent advancements affirm PDT’s efficacy, utilizing ROS generation to induce cancer cell death. With a history spanning over decades, PDT’s dynamic evolution has expanded its application across dermatology, oncology and dentistry.”
PDT is a treatment technique that combines a photosensitizing drug with a specific wavelength of light to produce reactive oxygen species that selectively destroy abnormal cells. According to the National Cancer Institute (“NCI”), PDT works by administering a photosensitizer that accumulates in cancer or diseased tissue and then activating it with light, causing a localized reaction that damages targeted cells while largely sparing surrounding healthy structures. This targeted approach distinguishes PDT from traditional systemic treatments such as chemotherapy, which circulate throughout the body and can produce widespread side effects.
One of the key advantages of photodynamic therapy is its selectivity. Because the therapy is activated only where light is applied, clinicians can limit damage to nearby healthy tissue, potentially reducing long-term toxicity compared with radiation or cytotoxic drugs. “When cells that have absorbed photosensitizers are exposed to a specific wavelength of light, the photosensitizer produces a form of oxygen, called an oxygen radical, that kills them,” explains NCI. “Photodynamic therapy may also damage blood vessels in the tumor, which prevents it from receiving the blood it needs to keep growing. And, it may trigger the immune system to attack tumor cells, even in other areas of the body.”
Despite these advantages, traditional photodynamic approaches have faced limitations related to photosensitizer chemistry, depth of light penetration and treatment protocols. Advances in drug design and light delivery systems are now helping overcome these challenges. Researchers are increasingly exploring photosensitizers that respond to visible light wavelengths rather than damaging ultraviolet radiation, which may offer safer activation profiles and improved tissue penetration. The development of more refined photodynamic platforms is expanding the potential clinical applications of this modality.
Within this evolving landscape, Soligenix is advancing HyBryte(TM), or SGX301, the company’s proprietary photodynamic therapy based on synthetic hypericin, designed for the treatment of early stage cutaneous T-cell lymphoma. CTCL is a rare form of non-Hodgkin lymphoma that primarily affects the skin and can significantly impact quality of life through persistent lesions, itching and chronic symptoms. According to the Cutaneous Lymphoma Foundation, CTCL often requires long-term management and treatment strategies that balance effectiveness with tolerability, particularly in early-stage disease. HyBryte aims to address this need by providing a targeted, nonsystemic therapy activated by safe visible light.
Unlike systemic treatments that circulate throughout the body, HyBryte involves topical application followed by controlled exposure to visible light, activating the drug locally in affected skin areas. HyBryte also leverages visible fluorescent or LED light activation rather than ultraviolet wavelengths, aligning with broader trends toward safer photodynamic strategies. This approach is designed to selectively destroy malignant cells while minimizing systemic exposure, potentially improving safety and tolerability compared with traditional therapies.
Soligenix has evaluated HyBryte in multiple clinical studies for CTCL, where photodynamic therapy offers a particularly appealing strategy due to the disease’s skin-focused nature. Late last year, the company achieved an important safety milestone in its confirmatory Phase 3 clinical trial of HyBryte for CTCL treatment. The company announced that its first Data Monitoring Committee meeting for its confirmatory Phase 3 study concluded that there are no safety concerns with the ongoing Phase 3 study and that HyBryte has an acceptable safety profile that remains consistent with the safety data from all prior clinical studies.
Clinical development efforts have focused on demonstrating efficacy while maintaining quality of life, an important consideration given the chronic nature of CTCL and the potential side effects associated with systemic therapies such as chemotherapy or immunomodulators. The localized activation mechanism of photodynamic therapy allows repeated treatments with potentially fewer cumulative toxicities, making it an attractive alternative for long-term disease management.
Beyond oncology, Soligenix is also exploring the potential of HyBryte in psoriasis, a chronic inflammatory skin disease affecting millions worldwide. The expansion into additional dermatologic indications highlights the flexibility of photodynamic platforms, which can be adapted to target different pathological processes depending on the photosensitizer used and the treatment protocol. As research continues, photodynamic therapy may evolve into a versatile platform capable of addressing both malignant and nonmalignant inflammatory skin conditions.
The broader promise of photodynamic therapy lies in its ability to bridge precision medicine and targeted drug delivery. Rather than relying solely on molecular targeting or systemic exposure, PDT introduces a physical activation step through light, enabling clinicians to control where and when treatment occurs. As researchers refine photosensitizers and light delivery technologies, the therapy’s potential applications could expand further into deeper tumors, combination regimens and immune-modulating strategies.
Companies such as Soligenix are contributing to this exploration by advancing therapies that combine selective targeting with improved safety profiles, offering hope for patients who need effective options with fewer systemic burdens. From the laboratory to clinical practice, the continued development of light-activated therapies underscores the growing role of precision-focused approaches in the future of disease treatment.
For more information, visit www.Soligenix.com.
NOTE TO INVESTORS: The latest news and updates relating to SNGX are available in the company’s newsroom at https://ibn.fm/SNGX
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