Providing Strategic Medical Guidance in Advancing HyBryteâ"¢ Clinical Development , /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today the update of its United States (U.S.) Medical Advisory Board (MAB) for cutaneous T-cell lymphoma (CTCL) to provide medical/clinical strategic guidance to the Company as it advances the ...

Core Viewpoint - Soligenix, Inc. has demonstrated the extended stability of its ebolavirus vaccines using the ThermoVax® platform, maintaining potency after two years at high temperatures, which is crucial for deployment in virus-endemic regions and for pandemic preparedness [1][2]. Group 1: Vaccine Stability and Efficacy - The bivalent and trivalent vaccines, targeting Zaire ebolavirus, Sudan ebolavirus, and Marburg marburgvirus, showed no change in potency after two years of storage at 40°C (104°F) [1]. - The vaccines have exhibited broad immune responses in mice and up to 100% protection in non-human primates [2][3]. - The ThermoVax® platform enhances the stability of vaccines, making them competitive with other technologies that require stringent cold-storage [2][3]. Group 2: Vaccine Development and Manufacturing - The filovirus vaccines are subunit protein vaccines developed in collaboration with Dr. Axel Lehrer, utilizing a robust protein manufacturing process [3][4]. - The vaccines are designed to be heat-stable and can be lyophilized, allowing for easy reconstitution with water prior to use [3]. - The adjuvant used in the vaccines has been tested in Phase 1 and Phase 2 clinical studies, supporting its safety and efficacy [4]. Group 3: Regulatory and Market Position - Soligenix has received Orphan Drug Designation from the FDA for its filovirus vaccines, providing market exclusivity and various financial benefits [5]. - The company is positioned to leverage government grants and regulatory advantages to support clinical trials and potential market entry [5]. Group 4: Public Health Context - Filoviruses, including Ebola and Marburg, have high mortality rates and limited treatment options, highlighting the need for effective vaccines [6][7]. - Recent outbreaks of Sudan and Marburg viruses underscore the importance of developing vaccines that can be stored and distributed easily in affected regions [6][7].

Company Overview - Soligenix, Inc. is a late-stage biopharmaceutical company focused on developing and commercializing products for rare diseases with unmet medical needs [3] - The company has a Specialized BioTherapeutics segment that is advancing HyBryte™ (SGX301), a novel photodynamic therapy for cutaneous T-cell lymphoma (CTCL), towards potential commercialization following the successful completion of a second Phase 3 study [3] - Other development programs include SGX302 for psoriasis, SGX942 for inflammatory diseases, and SGX945 for Behçet's Disease [3] Public Health Solutions - The Public Health Solutions segment includes the development of RiVax®, a ricin toxin vaccine candidate, and vaccines targeting filoviruses and COVID-19 [4] - The vaccine programs utilize the proprietary ThermoVax® technology and have received support from government grants and contracts from agencies such as NIAID, DTRA, and BARDA [4] Upcoming Events - Christopher J. Schaber, Ph.D., President and CEO of Soligenix, will present at the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025, with an on-demand presentation available on September 5, 2025 [1] - Key management members will hold one-on-one meetings throughout the conference, and registered attendees can schedule meetings via the conference platform [2]

Core Insights - Soligenix, Inc. is advancing HyBryte™ (synthetic hypericin) as a potential new therapy for early-stage cutaneous T-cell lymphoma (CTCL), specifically targeting mycosis fungoides (MF), the most common form of CTCL [1][7] - The company emphasizes the urgent need for safer and more effective therapies for CTCL, as there has not been a new FDA-approved skin-directed therapy in over 10 years [3][4] Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing products for rare diseases with unmet medical needs, including HyBryte™ for CTCL and other therapeutic programs [7] - The company is also involved in vaccine development for biodefense and infectious diseases, supported by government funding [8] Clinical Development - Dr. Ellen Kim, the Lead Principal Investigator, highlighted the promising clinical results from ongoing Phase 3 FLASH studies, noting that participants have experienced positive outcomes with no serious adverse events leading to dropouts [3][4] - HyBryte™ operates through a unique mechanism that does not damage DNA, theoretically reducing the risk of skin cancer compared to traditional phototherapy [4] Research and Future Directions - Dr. Kim expressed excitement about the open enrollment in HyBryte™ clinical trials, emphasizing the critical role of patient participation in advancing new therapies [6] - The company aims to seek regulatory approvals for HyBryte™ following the successful completion of its second Phase 3 study [7]

Core Insights - Soligenix Inc. is a late-stage biopharmaceutical company focused on developing products for rare diseases with unmet medical needs [1][5] - The company has selected IBN to lead its corporate communications efforts, leveraging IBN's extensive distribution network to enhance visibility [1][4] Company Overview - Soligenix operates through two main segments: Specialized BioTherapeutics, which targets oncology and inflammation therapies, and Public Health Solutions, which focuses on vaccines and therapeutics for biothreats and infectious diseases [2] - The company is advancing multiple late-stage clinical programs, including HyBryte™ (SGX301) for cutaneous T-cell lymphoma, and other candidates for psoriasis (SGX302), oral mucositis (SGX942), and Behçet's disease (SGX945) [2][5] Public Health Initiatives - The Public Health Solutions segment includes development programs for vaccines against ricin poisoning (RiVax®), Ebola (SuVax™), and Marburg (MarVax™), supported by approximately $60 million in non-dilutive government grants and contracts [3][6] - The vaccine development utilizes proprietary heat stabilization technology known as ThermoVax® [6] Strategic Partnerships - IBN will utilize its investor-focused distribution network, which includes over 5,000 syndication outlets and a large social media following, to increase awareness for Soligenix [4][5] - IBN has over 19 years of experience and has assisted more than 500 client partners, positioning it to effectively reach a broad audience [5]

Core Viewpoint - The combination of the COVID adenovirus vaccine and CiVax™ shows broader protection against COVID-19 variants compared to a two-shot mRNA vaccination series, indicating potential advantages in vaccine efficacy and distribution logistics [1][2]. Group 1: CiVax™ Vaccine Development - CiVax™ is a heat-stable subunit vaccine candidate for COVID-19, demonstrating broad immune responses in preclinical studies with mice and non-human primates [2][4]. - The vaccine can be stored at ambient temperatures and requires only reconstitution with sterile water before use, simplifying global vaccination efforts [2][3]. - Development of CiVax™ was partially funded by a $1.5 million Small Business Innovation Research (SBIR) grant from the National Institute of Allergy and Infectious Diseases (NIAID) [5]. Group 2: Technological Advancements - The ThermoVax® platform has successfully stabilized vaccines for various pathogens, enhancing the standard protein subunit vaccination technology [2][9]. - CiVax™ has shown efficacy as a booster after other primary vaccinations against COVID-19, providing broad immune coverage [4][2]. Group 3: Collaboration and Research - The development of CiVax™ is a result of collaboration with Axel Lehrer, PhD, from the University of Hawaiʻi at Mānoa, focusing on heat-stable vaccines for both COVID-19 and filoviruses [2][3]. - The research emphasizes the need for robust technology platforms to rapidly develop vaccines for emerging infectious diseases, as demonstrated by the COVID-19 pandemic [6].