Innovation is alive and well in the biotech industry. And while many of the giants focus on big diseases, there is a big arena filled with unmet medical needs that also needs attention. Why are niche markets profitable? Less competition.
Late-stage biopharmaceutical company Soligenix, Inc. (NASDAQ: SNGX) is focused on developing and commercializing products to treat rare diseases where there is an unmet medical need.
The company’s specialized biotherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ (SGX301 or synthetic hypericin sodium) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). With a successful Phase 3 study completed, regulatory approval is being sought and commercialization activities for this product candidate are being advanced initially in the U.S. Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, the company’s first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203).
The company’s public health solutions business segment includes active development programs for RiVax®, our ricin toxin vaccine candidate, as well as our vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax™, its vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of its vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).
Patient enrollment has recently been opened for the investigator-initiated study (IIS) at the University of Pennsylvania, supported by a $2.6 million Orphan Products Development grant award by the U.S. Food and Drug Administration (FDA)!
The IIS will evaluate the expanded treatment, including up to 12 months of treatment, with HyBryte™ (synthetic hypericin) in patients with early-stage cutaneous T-cell lymphoma (CTCL).
The trial is sponsored by Ellen Kim, MD, Director, Penn Cutaneous Lymphoma Program, Vice Chair of Clinical Operations, Dermatology Department, and Professor of Dermatology at the Hospital of the University of Pennsylvania who was a leading enroller in the recently published positive Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study in the treatment of early-stage CTCL.
“"CTCL is an incredibly difficult to treat orphan disease and remains an area of unmet medical need with a very limited number of safe and effective treatment options. With the demonstration of statistical significance in the primary endpoint and continued improvement in treatment response with extended treatment in our published Phase 3 FLASH study, we are continuing discussions with FDA on the design of a second confirmatory Phase 3 study. This IIS has the potential to augment the expanding safety database for synthetic hypericin, as well as provide further real-world evidence into the practical use of HyBryte™ once commercially available."
HyBryte™ (research name SGX301) utilizes safe, visible light for activation. The active ingredient in HyBryte™ is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by the malignant T-cells, and then activated by visible light approximately 24 hours later.
The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker plaques and lesions. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging drugs and other phototherapy that are dependent on ultraviolet exposure.
Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective.
Cutaneous T-Cell Lymphoma treatment for early stage CTCL lesions is complicated given the side effects of many commonly used approaches. HyBryte™ (synthetic hypericin or SGX301) may provide a safer, more convenient alternative. It is a topical ointment which is applied to the lesions and then activated by safe visible fluorescent light. HyBryte™ is being tested as a photodynamic light therapy with an enhanced safety profile and a treatment regimen that may be completed in as little as 6 weeks.
SNGX’s pivotal Phase 3 clinical study (the “FLASH” study) for CTCL has completed enrollment showing a statistically significant outcome after 6 weeks treatment (p=0.04) with continued improvement to 40% response rate after 12 weeks treatment (p<0.0001).
Background on Cutaneous T-Cell Lymphoma. The majority of patients with CTCL have early stage disease (called Mycosis Fungoides) which, with careful disease management, may never progress to later stages of disease. CTCL affects about 6% of non-Hodgkin’s lymphoma patients.
Approximately 20,000 patients in the US are believed to have this chronic disease with similar prevalence in Europe and significant incidence in Asia as well. CTCL is caused by the migration of malignant T-cells to the surface of the skin.
The characteristic lesions, tumors and plaques associated with CTCL can be extremely uncomfortable and treatment for cutaneous t-cell lymphoma is believed to slow disease progression.
There is NO FDA-approved first-line therapy for CTCL. Every potential treatment is either used off-label (i.e., it wasn’t specifically approved for use in CTCL) or is supposed to be used when other CTCL treatments fail. There is a high risk of serious side effects with most current therapies. Because early-stage CTCL is a disease which patients can live with for a long time, it is very important to prevent the accumulation of toxic side effects (such as the risk for melanoma) while maintaining effective treatment of the lesions. Living with CTCL means using a number of different therapies over a lifetime, while managing the accumulating toxic side effects.
HyBryte™ has demonstrated safety in a Phase 1 clinical study in healthy volunteers. In a Phase 2, placebo-controlled, clinical study in patients with CTCL, the drug was safe, well tolerated, and effective in ameliorating the skin lesions.
Synthetic hypericin may also be useful in psoriasis.
Psoriasis is characterized by the migration of T-cells to the skin surface. However, unlike in CTCL, the T-cells in psoriasis are not malignant. Psoriasis affects over 7 million adults in the US. Photodynamic therapy is a frequently employed initial therapy for psoriasis, despite the need for ultraviolet light exposure and its attendant risk of melanoma and non-melanoma skin cancer. The Phase 1/2 clinical study showed that hypericin and visible light phototherapy is also potentially effective in treating these lesions.
The company's ThermoVax vaccine platform has been funded to date by government grants and contracts and centers around heat-stable freeze-dried vaccines, which only require water to be added prior to use and can be stored for at least 12 months at 40 degrees Celsius (104 degrees Fahrenheit), compared with many vaccines or vaccine candidates that require strict cold-chain storage of -60 degrees Celsius (-76 degrees Fahrenheit) or less.
Potential vaccine candidates being developed by Soligenix include RiVax(R), a ricin toxin vaccine that is furthest along in the development pipeline, as well as a Marburg and Ebola filovirus vaccines, and a Covid-19 vaccine, all generating consistent protection.
Presently, the National Institutes of Health (NIH) ranks both the Ebola and Marburg filoviruses as category A priority pathogens, and Ebola, Marburg, ricin and Covid are all in the USDA's top 20 list of biological agents/toxins that could pose a severe health threat to both humans and animals, hence the critical importance of this category of work.
Chief Executive Officer
Wendy brings 25 years of success launching, relaunching and building organizations in diagnostic, surgical and capital sales, with a focus in Oncology and Women’s Health. She has achieved record revenue growth at a variety of organizations from early-stage start ups to Fortune 500 companies. Most recently, Wendy has served as CCO at Agendia, Animated Dynamics and Biodesix. Prior to Biodesix, Wendy served as VP of Sales with Integrated Oncology (LabCorp subsidiary) where she led the
successful integration of Genzyme Genetics following its acquisition for $925M. Before joining Integrated Oncology, she held several leadership roles with Cytyc Corporation prior to its $6.2B acquisition by Hologic.
Soligenix, Inc. (NASDAQ: SNGX)’s pipelines focus on orphan and unmet medical needs across a range of indications that could lead to substantial commercialization and revenues.
As detailed in the company’s corporate presentation, SNGX estimates the total addressable global market potential across both its business segments to be approximately $2 billion!
“When you look at our pipeline, current stock price and market cap, the potential upside is significant, in my opinion,” remarked CEO Christopher J. Schaber, PhD.
With FDA approval, HyBryte can be a potential game-changer in the treatment of CTCL.
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