Core Viewpoint - Soligenix, Inc. has received a $2.6 million FDA Orphan Products Development grant to support an investigator-initiated study evaluating the extended use of HyBryte™ for treating early-stage cutaneous T-cell lymphoma (CTCL), showing promising initial results with over 70% of patients achieving treatment success [1][12]. Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing treatments for rare diseases with unmet medical needs, particularly through its Specialized BioTherapeutics segment, which includes HyBryte™ for CTCL [15]. - The company is advancing its product pipeline, including potential treatments for psoriasis and inflammatory diseases, alongside its vaccine programs targeting bioterror threats and COVID-19 [16]. Study Details - The ongoing open-label study has enrolled nine patients, with five achieving "Treatment Success," defined as a ≥50% improvement in the mCAILS score [1]. - The study allows for treatment over 12 months with twice-weekly dosing, and initial results indicate that HyBryte™ is safe and well-tolerated [1][12]. - The Phase 3 FLASH study previously demonstrated a 16% treatment response rate for HyBryte™ compared to 4% for placebo, with a statistically significant p-value of 0.04 [5]. Treatment Efficacy - In the second treatment cycle of the FLASH study, a 40% response rate was observed among patients treated for 12 weeks, significantly higher than the placebo group [6]. - The third optional treatment cycle showed that 66% of patients opted to continue treatment, with 49% demonstrating a positive response [7]. Safety Profile - HyBryte™ has a favorable safety profile, not associated with DNA damage, making it a safer alternative to existing therapies that carry significant side effects [8]. - The treatment's mechanism avoids the risks of secondary malignancies, which are common with current therapies for CTCL [8]. Regulatory and Future Studies - The FDA and EMA require a second successful Phase 3 trial for marketing approval, with the FLASH2 study expected to begin before the end of 2024 [9][10]. - The FLASH2 study will replicate the successful design of the first FLASH study, extending treatment duration to 18 weeks to assess efficacy in a real-world setting [10].

Core Viewpoint - Soligenix, Inc. has initiated patient enrollment for its confirmatory Phase 3 study, FLASH2, to evaluate HyBryte™ in treating cutaneous T-cell lymphoma (CTCL), building on previous successful studies [1][9]. Company Overview - Soligenix is a late-stage biopharmaceutical company focused on developing treatments for rare diseases with unmet medical needs, including HyBryte™ for CTCL [14]. - The company is also developing other products, including SGX302 for psoriasis and SGX942 for inflammatory diseases [14][15]. Product Details - HyBryte™ (SGX301) is a novel photodynamic therapy using synthetic hypericin activated by safe visible light, targeting malignant T-cells in CTCL [3][4]. - The treatment avoids risks associated with DNA-damaging drugs and has shown significant anti-proliferative effects on malignant T-cells [3][8]. Clinical Study Insights - The FLASH2 study will enroll approximately 80 subjects with early-stage CTCL, extending the treatment duration to 18 weeks of continuous therapy [2][9]. - In the previous Phase 3 FLASH study, a treatment response of 49% was observed in patients completing 18 weeks of therapy [5][9]. - The FLASH2 study aims to replicate the successful design of the first FLASH study while providing a more prolonged treatment assessment [9][10]. Regulatory and Funding Support - HyBryte™ has received orphan drug and fast track designations from the FDA and orphan designation from the EMA [4]. - The FDA awarded a $2.6 million Orphan Products Development grant to support the evaluation of HyBryte™ for early-stage CTCL treatment [11]. Market Context - CTCL is a rare form of non-Hodgkin's lymphoma, affecting approximately 31,000 individuals in the U.S. and 38,000 in Europe, with no current cure available [12][13]. - The disease's treatment landscape is motivated by safety concerns, as existing therapies often have significant side effects [8].

Significant Efficacy against Plaque Lesions Also Demonstrated with HyBryte™PRINCETON, N.J., Dec. 2, 2024 /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 that analysis of the post-treatment data from the open-label study (protocol HPN-CTCL-04) comparing HyBryte™ (synthetic hypericin) to Valchlor® (mechlorethamine) has ...

Phase 3 clinical study of HyBryte™ in CTCL initiating in 2024PRINCETON, N.J., Nov. 19, 2024 /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 formation of a European Medical Advisory Board (MAB) to provide additional medical/clinical strategic guidance to the Company as it advances its confirmatory Phase 3 multicen ...

Study DUS-AUBD-01 opens patient enrollmentPRINCETON, N.J., Nov. 14, 2024 /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 that it has opened patient enrollment for its Phase 2 study (protocol number DUS-AUBD-01) evaluating SGX945 (dusquetide) in the treatment of Behçet's Disease."We are pleased to have received FDA cl ...

Core Insights - Soligenix, Inc. is focused on developing treatments for rare diseases with unmet medical needs and has announced recent accomplishments and financial results for Q3 2024 [1] Recent Accomplishments - The Hong Kong Patent Office granted a patent for a novel proprietary process of producing highly purified synthetic hypericin on October 22, 2024 [3] - Lead investigators presented findings on HyBryte™ for CTCL treatment at a European cancer research organization on October 7, 2024 [3] - A partnership with Sterling Pharma Solutions was established to optimize production technology for synthetic hypericin on October 3, 2024 [3] - The European Patent Office granted a similar patent for synthetic hypericin production on September 3, 2024 [3] Clinical Activities and Milestones - The company plans to initiate a Phase 3 placebo-controlled study for HyBryte™ in early-stage CTCL by year-end 2024 [2] - A Phase 2 study for SGX945 in Behçet's disease is set to begin shortly, with top-line results expected in the first half of 2025 [2] - Data from the ongoing Phase 2 study of SGX302 in mild-to-moderate psoriasis is anticipated in the first half of 2025 [2] Financial Results - Soligenix reported no revenue for Q3 2024, compared to $0.1 million in Q3 2023, with revenues primarily from government contracts and grants [4] - The net loss for Q3 2024 was $1.7 million, or ($0.78) per share, consistent with the loss in Q3 2023, which was ($2.56) per share [5] - Research and development expenses increased to $1.0 million in Q3 2024 from $0.8 million in Q3 2023, attributed to costs for new clinical studies [6] - General and administrative expenses decreased to $0.9 million in Q3 2024 from $1.0 million in Q3 2023, mainly due to lower legal and professional fees [7] - As of September 30, 2024, the company's cash position was approximately $9.8 million [7]

Soligenix, Inc. to Present at the 2024 ThinkEquity Conference Princeton, NJ, October 24, 2024 – PRISM MediaWire – 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, today announced that it will be participating in The ThinkEquity Conference on October 30, 2024, at the Mandarin Oriental Hotel in New York. The ThinkEquity Conference gathers institut ...

Active Ingredient in HyBryte™ for the Treatment of Cutaneous T-Cell Lymphoma and SGX302 for the Treatment of PsoriasisPRINCETON, N.J., Oct. 22, 2024 /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 that the Hong Kong Patent Office has granted the patent entitled "Systems and Methods for Producing Synthetic Hypericin". ...

PRINCETON, N.J., Oct. 16, 2024 /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 that the Company will be providing a corporate update at the upcoming investor conferences on the dates below. 2024 Maxim Healthcare Virtual Summit, held October 17, 2024. For more information, please refer to the conference website https: ...

U.S. Expansion of Synthetic Hypericin Active Ingredient Manufacturing PRINCETON, N.J., Oct. 3, 2024 /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 that it has established a partnership agreement with Sterling Pharma Solutions (Sterling) to optimize and implement a commercially viable, scalable production technology ...