Soligenix Announces Formation of European Medical Advisory Board for Cutaneous T-Cell Lymphoma

Phase 3 clinical study of HyBryte™ in CTCL initiating in 2024

PRINCETON, 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 multicenter, double-blind, placebo-controlled study evaluating the safety and efficacy of HyBryte™ (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) patients with early-stage disease. This confirmatory, 18-week study is expected to enroll approximately 80 patients in the United States (U.S.) and Europe, and is targeted to begin patient enrollment by the end of 2024 with top-line results anticipated in the second half of 2026.

"Stemming from the positive feedback from the European Medicines Agency (EMA) on the key design components of our confirmatory Phase 3 placebo-controlled study evaluating the safety and efficacy of HyBryte™, we consider expert European involvement a necessary component for the development of this program. As such, it is an honor to have such a prestigious and dedicated group of clinicians and leaders in the field committed to working with us as we develop HyBryte™," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We have assembled some of the leading CTCL experts, who collectively have the experience of treating thousands of patients with this rare condition, and complement the strong CTCL MAB we've established in the U.S. The support of these European experts is a further testament to the opportunity HyBryte™ could provide for patients suffering from this disease worldwide."

Comprised of internationally renowned physicians with extensive experience in treating and running clinical research trials in CTCL, this esteemed MAB will play an important advisory role in the conduct and interpretation of the upcoming Phase 3 clinical study and the associated regulatory interactions with health authorities. The MAB will provide feedback, input, and guidance on clinical strategies and their implementation, as well as on other critical items, such as health economics and reimbursement, to assist Soligenix in meeting the needs of patients suffering from CTCL.

European MAB Members

Martine Bagot, MD, PhD – France

Martine Bagot is Professor and Head of the Department of Dermatology at the Hôpital Saint Louis in Paris, France and co-directs the INSERM Unit 976 Human Immunology, Pathophysiology and Immunotherapy. Dr. Bagot also chairs the French Group for the Study of Cutaneous Lymphomas. Dr. Bagot has co-authored more than 750 peer-reviewed publications, most of which are in the complementary fields of dermatology, immunology, and oncology. Main publications include numerous clinical trials in dermato-oncology. Dr. Bagot is involved with major European international societies such as the International Society for Cutaneous Lymphoma (ISCL), The European Society for Dermatological Research (ESDR), and the European Organisation for Research and Treatment of Cancer (EORTC) Cutaneous Lymphoma Task Force, where she previously served as its President and is currently a steering committee member.

Pietro Quaglino, MD – Italy

Pietro Quaglino is Associate Professor of Dermatology at the Department of Medical Sciences, University of Turin Medical School, Italy. His clinical and research activities focus on melanoma, cutaneous lymphoma, and immune dermatology. He is the principal investigator of several clinical trials in melanoma and cutaneous lymphoma. He is board member of the GIPMe (Gruppo Italiano Polidisciplinare sul Melanoma), board member and treasurer of the IMI (Italian Melanoma Intergroup), past chairman and current steering committee member of the EORTC Cutaneous Lymphoma Task Force, and member of the Board Directors of the ISCL. He has published more than 160 peer-reviewed scientific papers. Dr. Quaglino is Assistant Editor of the Giornale Italiano di Dermatologia e Venereologia, reviewer of international journals on dermatology and referee for ANVUR (National Agency for the Evaluation of Universities and Research Institutes).

Pablo Luis Ortiz-Romero, MD, PhD – Spain

Pablo Luis Ortiz-Romero is Professor of Dermatology and Head of the Dermatology Department at Hospital Universitario 12 de Octubre, Spain. He is a distinguished dermatologist and researcher specializing in cutaneous lymphomas, particularly mycosis fungoides and Sézary syndrome forms of CTCL. His experience is extensive, having contributed to over 200 publications and numerous clinical studies in the field. Dr. Ortiz-Romero is affiliated with the ISCL and has served on its Board of Directors. His research includes innovative treatments for CTCL, and he is one of the leading physicians focused on novel treatments for CTCL in Spain. He served as the Secretary General of the EORTC Cutaneous Lymphoma Tumor Group and is currently a member of its steering committee.

About HyBryte™

HyBryte™ (research name SGX301) is a novel, first-in-class, photodynamic therapy utilizing safe, visible light for activation. The active ingredient in HyBryte™ is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions that is taken up by the malignant T-cells, and then activated by safe, visible light approximately 24 hours later. The use of visible light in the red-yellow spectrum has the advantage of penetrating more deeply into the skin (much more so than ultraviolet light) and therefore potentially treating deeper skin disease and thicker plaques and lesions. This treatment approach avoids the risk of secondary malignancies (including melanoma) inherent with the frequently employed DNA-damaging drugs and other phototherapy that are dependent on ultraviolet exposure. Combined with photoactivation, hypericin has demonstrated significant anti-proliferative effects on activated normal human lymphoid cells and inhibited growth of malignant T-cells isolated from CTCL patients. In a published Phase 2 clinical study in CTCL, patients experienced a statistically significant (p=0.04) improvement with topical hypericin treatment whereas the placebo was ineffective. HyBryte™ has received orphan drug and fast track designations from the U.S. Food and Drug Administration (FDA), as well as orphan designation from the European Medicines Agency (EMA).

The published Phase 3 FLASH trial enrolled a total of 169 patients (166 evaluable) with Stage IA, IB or IIA CTCL. The trial consisted of three treatment cycles. Treatments were administered twice weekly for the first 6 weeks and treatment response was determined at the end of the 8th week of each cycle. In the first double-blind treatment cycle (Cycle 1), 116 patients received HyBryte™ treatment (0.25% synthetic hypericin) and 50 received placebo treatment of their index lesions. A total of 16% of the patients receiving HyBryte™ achieved at least a 50% reduction in their lesions (graded using a standard measurement of dermatologic lesions, the CAILS score) compared to only 4% of patients in the placebo group at 8 weeks (p=0.04) during the first treatment cycle (primary endpoint). HyBryte™ treatment in this cycle was safe and well tolerated.

In the second open-label treatment cycle (Cycle 2), all patients received HyBryte™ treatment of their index lesions. Evaluation of 155 patients in this cycle (110 receiving 12 weeks of HyBryte™ treatment and 45 receiving 6 weeks of placebo treatment followed by 6 weeks of HyBryte™ treatment), demonstrated that the response rate among the 12-week treatment group was 40% (p