Soligenix Positioned for Growth: Late-stage Pipeline and Key Q4 Milestones

With several more significant catalysts anticipated yet this year, Soligenix is positioned for growth in several key industry categories while maintaining a $24 million market cap.

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The late clinical-stage biopharma is preparing to file a new drug application (NDA) for HyBryte™ (synthetic hypericin), which may become the first-in-class treatment for cutaneous T-cell lymphoma (CTCL), a rare disease spurred by the migration of malignant T-cells to the surface of the skin that manifests in painful lesions, tumors and plaques.

The company’s public health heat stable vaccine platform has also been hailed for its potential to prevent and manage future pandemics.

HyBryte progressing to the FDA finish line

HyBryte demonstrated strong antiviral effects and therapeutic efficacy in its recent Phase 3 FLASH study. CTCL affects about 40,000 patients worldwide and has no cure; median survival drops to only 2.5 years when the disease is in a more advanced stage.

Soligenix plans to commercialize HyBryte in the United States as a specialized market with a sound referral base, low barriers to access, a finely honed ability to reach patients and high likelihood of reimbursement. A number of dermatology key opinion leaders who currently provide diagnosis and treatment for CTCL patients participated in the recent Phase 3 trial.

The global CTCL market was estimated at $1.6 billion in 2021 and is expected to grow to about $3.5 billion by 2030 with a compounded annual growth rate nearing 10 percent. Soligenix reports a U.S. target market valued to exceed $90 million, which may be modest in terms of total addressable market.

The company has also received FDA clearance to commence a Phase 2 study for the use of  synthetic hypericin (active ingredient in HyBryte) to combat psoriasis and other potential disease indications. According to Fortune Business Insights, the global psoriasis treatment market is projected to reach nearly $40.6 billion in the next five years.

Adding value addressing major public health threats

Soligenix’s second business segment is a heat-stable vaccine platform that targets some of the biggest worldwide health threats. 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, compared with many vaccines or vaccine candidates that require strict cold-chain storage of -60 degrees Celsius or less.

Potential vaccine candidates being developed by Soligenix include RiVax^®, 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.

In October, Soligenix announced it had been invited by the Biomedical Advanced Research and Development Authority (BARDA) Division of Chemical, Biological, Radiological and Nuclear Medical Countermeasures to submit a full contract proposal for the development of single-vial, adjuvanted, heat stable subunit vaccines to prevent filovirus infection. 

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