Soligenix Shows Pipeline Depth From Heat Stabilization Technology For Filovirus Vaccine Platform; Eyes Remain Focused On SGX301 Data Release

Soligenix, on Thursday February 27th, gave the market some more good news. This time the company highlighted data from its ongoing collaboration with the University of Hawai’i at Manoa (UHM) and Hawaii Biotech Inc. (HBI) that has resulted in what the Company believes is a significant milestone in the development of heat stable filovirus vaccines. According to the update, the platform has demonstrated feasible thermostable formulations and protection in non-human primate models with both monovalent and bivalent vaccine candidates in the three most deadly human pathogenic filoviruses (Ebola virus, Sudan virus and Marburg virus).

Soligenix (NASDAQ: SNGX), in the release, pointed to its Public Health Solutions business segment, and its ongoing collaborations with Axel Lehrer, PhD of the Department of Tropical Medicine, Medical Microbiology and Pharmacology, John A. Burns School of Medicine (JABSOM), UHM and HBI that have demonstrated the feasibility of developing heat stable subunit protein vaccines for filovirus. Specifically, protective efficacy has been demonstrated in non-human primates against infection with Ebola virus, Sudan virus, and Marburg virus. Additionally, protection has been achieved with both monovalent and bivalent vaccine combinations. Formulation conditions have been identified to enable heat stabilization of each antigen, alone or in combination, for at least 12 weeks at 40 degrees Celsius (104 degrees Fahrenheit).

The February 27th release further stated that Soligenix and its collaborators are now focusing specifically on accelerating development of a Marburg virus (MARV) vaccine, which is one of the most deadly viruses and has caused multiple disease outbreaks with significant mortality since the 1960s and for which there exists no approved vaccine or treatment.

Commenting on the program developments, Chris Schaber, PhD,President and CEO of Soligenix, stated,“We believe that creating a vaccine with enhanced stability at elevated temperatures, which can obviate the costs and logistical burdens associated with cold chain storage and distribution, has the potential to provide a distinct advantage over other vaccines currently in development,” He added, “In concert with US government feedback, we will now look to focus specifically on Marburg virus.”

The update, which comes as investors are eyeing the release of topline data for the company’s late-stage Phase 3 SGX301 trial, shows the added depth that Soligenix has in the pipeline that can target unmet medical needs as well as to provide heat-stabilization technology to meaningful and potentially urgent vaccine products.

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Eyes Focused On Q1 Topline Data Release For SGX301

Aside from the good news on Thursday, investors also have their eyes trained on Soligenix with the imminent release of topline data after completing final enrollment for SGX301, a pivotal Phase 3 trial targeting the treatment of cutaneous T-cell lymphoma. A successful report may position the company for significant increases to shareholder value before the end of Q1 2020, and ultimately position the company to commercialize its first drug in a market that is estimated at a more than $200 million revenue opportunity.

The Phase 3 (FLASH) clinical trial is focused on the potential benefits of Soligenix’s topical drug ointment SGX301, or synthetic hypericin, in the treatment of cutaneous T-cell lymphoma (CTCL). CTCL is a rare type of Non-Hodgkin’s Lymphoma that sits high on the list of conditions that has no current or effective drug treatment, pushing Soligenix to fill the demand to serve this unmet medical need. Further, a positive final data set from the SGX301 trial can position the drug to become the front-line standard of care option, replacing the often ineffective cancer treatments that involve the mutation of DNA, most of which are known to cause collateral damage, inclusive of skin damage, and even secondary cancers that must be treated again. Moreover, because there is no current front-line care nor cure for CTCL, doctors have been forced to focus purely on the management of the discomfort caused by the disease’s painful skin lesions.

And, with interim data demonstrating encouraging results, SNGX’s SGX301 may be in the unique and sole position to offer a first-in-class method to manage this rare and uncomfortable disease.

While investors embraced the news on Thursday of the continued progress in its Public Health Solutions business segment, the primary attention during the next 31 days will remain on SGX301 data. If that data can mimic interim data, it could become a transformative event for Soligenix.


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