HyBryte™ Expanded Treatment Continues to Demonstrate Positive Outcomes in Early-Stage Cutaneous T-Cell Lymphoma

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].