Soligenix Announces Partnership with Sterling Pharma Solutions
Soligenix (Nasdaq: SNGX) has announced a partnership with Sterling Pharma Solutions to optimize and implement commercially viable, scalable production technology for synthetic hypericin. This active ingredient is used in Soligenix's topical drug product formulations HyBryte™ and SGX302, which are being developed to treat cutaneous T-cell lymphoma (CTCL) and psoriasis, respectively.
The collaboration aims to transfer and optimize manufacturing processes and analytics for GMP manufacturing for clinical trials, with the intention of establishing a long-term commercial manufacturing partnership. This partnership is expected to help Soligenix expand its synthetic hypericin manufacturing capabilities, scale up the process, and reduce costs of goods.
The partnership will support the advancement of Soligenix's topical hypericin clinical programs, particularly HyBryte™ for early-stage CTCL treatment, towards potential worldwide commercialization.
Soligenix (Nasdaq: SNGX) ha annunciato una partnership con Sterling Pharma Solutions per ottimizzare e implementare una tecnologia di produzione commerciale scalabile per ipericina sintetica. Questo principio attivo è utilizzato nelle formulazioni di farmaci topici di Soligenix, HyBryte™ e SGX302, che sono in fase di sviluppo per trattare linfoma cutaneo a cellule T (CTCL) e psoriasi, rispettivamente.
La collaborazione mira a trasferire e ottimizzare i processi di produzione e le analisi per la produzione GMP per prove cliniche, con l'intenzione di stabilire una partnership di produzione commerciale a lungo termine. Si prevede che questa partnership aiuterà Soligenix ad espandere le sue capacità di produzione di ipericina sintetica, ad aumentare la scala del processo e a ridurre i costi dei beni.
La partnership supporterà l'avanzamento dei programmi clinici topici di ipericina di Soligenix, in particolare HyBryte™ per il trattamento precoce del CTCL, verso la potenziale commercializzazione globale.
Soligenix (Nasdaq: SNGX) ha anunciado una asociación con Sterling Pharma Solutions para optimizar e implementar tecnología de producción comercial escalable para hipericina sintética. Este ingrediente activo se utiliza en las formulaciones de productos farmacéuticos tópicos de Soligenix, HyBryte™ y SGX302, que se están desarrollando para tratar linfoma cutáneo de células T (CTCL) y psoriasis, respectivamente.
La colaboración tiene como objetivo transferir y optimizar los procesos de fabricación y análisis para la fabricación GMP para ensayos clínicos, con la intención de establecer una asociación de fabricación comercial a largo plazo. Se espera que esta asociación ayude a Soligenix a expandir sus capacidades de fabricación de hipericina sintética, aumentar la escala del proceso y reducir los costos de los bienes.
La asociación apoyará el avance de los programas clínicos tópicos de hipericina de Soligenix, particularmente HyBryte™ para el tratamiento de CTCL en etapas tempranas, hacia una posible comercialización global.
Soligenix (Nasdaq: SNGX)는 Sterling Pharma Solutions와 협력하여 합성 하이페리신의 상용화 가능하고 규모가 확장 가능한 생산 기술을 최적화하고 구현한다고 발표했습니다. 이 활성 성분은 Soligenix의 국소 약물 제품 포뮬레이션인 HyBryte™ 및 SGX302에 사용되며, 각각 피부 T세포 림프종(CTCL) 및 건선 치료를 위해 개발되고 있습니다.
이번 협력의 목표는 임상 시험을 위한 GMP 제조 프로세스 및 분석을 전이하고 최적화하는 것이며, 장기적인 상업적 제조 파트너십을 구축하는 것입니다. 이 파트너십은 Soligenix가 합성 하이페리신 제조 능력을 확장하고, 프로세스를 확대하며, 상품 비용을 낮추는 데 도움이 될 것으로 기대됩니다.
이 파트너십은 Soligenix의 국소 하이페리신 임상 프로그램, 특히 CTCL 초기 치료를 위한 HyBryte™의 발전을 지원하며, 잠재적인 전 세계 상용화를 향해 나아갈 것입니다.
Soligenix (Nasdaq: SNGX) a annoncé un partenariat avec Sterling Pharma Solutions pour optimiser et mettre en œuvre une technologie de production commercialement viable et évolutive pour l'hypericine synthétique. Cet ingrédient actif est utilisé dans les formulations de médicaments topiques de Soligenix, HyBryte™ et SGX302, qui sont en cours de développement pour traiter le lymphome cutané à cellules T (CTCL) et le psoriasis, respectivement.
La collaboration vise à transférer et à optimiser les processus de fabrication et les analyses pour la fabrication conforme aux GMP pour les essais cliniques, avec l'intention d'établir un partenariat de fabrication commerciale à long terme. Ce partenariat devrait aider Soligenix à étendre ses capacités de fabrication d'hypericine synthétique, à augmenter l'échelle du processus et à réduire les coûts des biens.
Le partenariat soutiendra l'avancement des programmes cliniques topiques d'hypericine de Soligenix, en particulier HyBryte™ pour le traitement précoce du CTCL, vers une éventuelle commercialisation mondiale.
Soligenix (Nasdaq: SNGX) hat eine Partnerschaft mit Sterling Pharma Solutions bekannt gegeben, um eine kommerziell viable, skalierbare Produktionstechnologie für synthetisches Hypericin zu optimieren und umzusetzen. Dieser Wirkstoff wird in den topischen Arzneimittelprodukten von Soligenix, HyBryte™ und SGX302, verwendet, die zur Behandlung von kutane T-Zell-Lymphomen (CTCL) und Psoriasis entwickelt werden.
Das Ziel der Zusammenarbeit ist es, Fertigungsprozesse und Analysen für die GMP-Herstellung klinischer Prüfungen zu übertragen und zu optimieren, mit der Absicht, eine langfristige kommerzielle Fertigungspartnerschaft aufzubauen. Es wird erwartet, dass diese Partnerschaft Soligenix dabei hilft, die Produktionskapazitäten für synthetisches Hypericin zu erweitern, den Prozess zu skalieren und die Kosten zu senken.
Die Partnerschaft wird die Weiterentwicklung der klinischen Programme von Soligenix für topisches Hypericin unterstützen, insbesondere HyBryte™ für die Behandlung von frühzeitigen CTCL, in Richtung einer potenziellen weltweiten Vermarktung.
- Partnership with Sterling Pharma Solutions to optimize synthetic hypericin production
- Potential for scalable and commercially viable manufacturing process
- Aims to reduce cost of goods for synthetic hypericin production
- Supports advancement of HyBryte™ for CTCL treatment towards commercialization
- None.
Insights
"We look forward to working with Sterling as we expand our synthetic hypericin manufacturing capabilities with the ultimate goals of scaling up the process while further reducing our cost of goods," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We look forward to building on our already strong relationship to advance our topical hypericin clinical programs, most notably, HyBryte™ for the treatment of early-stage CTCL, toward potential commercialization worldwide."
"Sterling is pleased to be collaborating with Soligenix on this important program. We believe that Sterling's expertise in active pharmaceutical ingredient manufacturing and testing will provide great value to the Soligenix program while we work towards a commercial supply agreement. We look forward to working with the Soligenix team to help advance this program through the upcoming HyBryte™ Phase 3 confirmatory clinical study," stated Adam Kujath, Site Head at Sterling Pharma Solutions'
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
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 (
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
The third (optional) treatment cycle (Cycle 3) was focused on safety and all patients could elect to receive HyBryte™ treatment of all their lesions. Of note,
Overall safety of HyBryte™ is a critical attribute of this treatment and was monitored throughout the three treatment cycles (Cycles 1, 2 and 3) and the 6-month follow-up period. HyBryte's™ mechanism of action is not associated with DNA damage, making it a safer alternative than currently available therapies, all of which are associated with significant, and sometimes fatal, side effects. Predominantly these include the risk of melanoma and other malignancies, as well as the risk of significant skin damage and premature skin aging. Currently available treatments are only approved in the context of previous treatment failure with other modalities and there is no approved front-line therapy available. Within this landscape, treatment of CTCL is strongly motivated by the safety risk of each product. HyBryte™ potentially represents the safest available efficacious treatment for CTCL. With very limited systemic absorption, a compound that is not mutagenic and a light source that is not carcinogenic, there is no evidence to date of any potential safety issues.
Following the first Phase 3 study of HyBryte™ for the treatment of CTCL, the FDA and the EMA indicated that they would require a second successful Phase 3 trial to support marketing approval. With agreement from the EMA on the key design components, the second, confirmatory study, called FLASH2, is expected to be initiated before the end of 2024. This study is a randomized, double-blind, placebo-controlled, multicenter study that will enroll approximately 80 subjects with early-stage CTCL. The FLASH2 study replicates the double-blind, placebo-controlled design used in the first successful Phase 3 FLASH study that consisted of three 6-week treatment cycles (18 weeks total), with the primary efficacy assessment occurring at the end of the initial 6-week double-blind, placebo-controlled treatment cycle (Cycle 1). However, this second study extends the double-blind, placebo-controlled assessment to 18 weeks of continuous treatment (no "between-Cycle" treatment breaks) with the primary endpoint assessment occurring at the end of the 18-week timepoint. In the first Phase 3 study, a treatment response of
In addition, the FDA awarded an Orphan Products Development grant to support the evaluation of HyBryte™ for expanded treatment in patients with early-stage CTCL, including in the home use setting. The grant, totaling
About Cutaneous T-Cell Lymphoma (CTCL)
CTCL is a class of non-Hodgkin's lymphoma (NHL), a type of cancer of the white blood cells that are an integral part of the immune system. Unlike most NHLs which generally involve B-cell lymphocytes (involved in producing antibodies), CTCL is caused by an expansion of malignant T-cell lymphocytes (involved in cell-mediated immunity) normally programmed to migrate to the skin. These malignant cells migrate to the skin where they form various lesions, typically beginning as patches and may progress to raised plaques and tumors. Mortality is related to the stage of CTCL, with median survival generally ranging from about 12 years in the early stages to only 2.5 years when the disease has advanced. There is currently no cure for CTCL. Typically, CTCL lesions are treated and regress but usually return either in the same part of the body or in new areas.
CTCL constitutes a rare group of NHLs, occurring in about
About Soligenix
Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing and moving toward potential commercialization of HyBryte™ (SGX301 or synthetic hypericin sodium) as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma (CTCL). With successful completion of the second Phase 3 study, regulatory approvals will be sought to support potential commercialization worldwide. Development programs in this business segment also include expansion of synthetic hypericin (SGX302) into psoriasis, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of inflammatory diseases, including oral mucositis in head and neck cancer, and (SGX945) in Behçet's Disease.
Our Public Health Solutions business segment includes development programs for RiVax®, our ricin toxin vaccine candidate, as well as our vaccine programs targeting filoviruses (such as Marburg and Ebola) and CiVax™, our vaccine candidate for the prevention of COVID-19 (caused by SARS-CoV-2). The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax®. To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Threat Reduction Agency (DTRA) and the Biomedical Advanced Research and Development Authority (BARDA).
For further information regarding Soligenix, Inc., please visit the Company's website at https://www.soligenix.com and follow us on LinkedIn and Twitter at @Soligenix_Inc.
This press release may contain forward-looking statements that reflect Soligenix's current expectations about its future results, performance, prospects and opportunities, including but not limited to, potential market sizes, patient populations, clinical trial enrollment, the expected timing for closing the offering described herein and the intended use of proceeds therefrom. Statements that are not historical facts, such as "anticipates," "estimates," "believes," "hopes," "intends," "plans," "expects," "goal," "may," "suggest," "will," "potential," or similar expressions, are forward-looking statements. These statements are subject to a number of risks, uncertainties and other factors that could cause actual events or results in future periods to differ materially from what is expressed in, or implied by, these statements, and include the expected amount and use of proceeds from the offering and the expected closing date of the offering. Soligenix cannot assure you that it will be able to successfully develop, achieve regulatory approval for or commercialize products based on its technologies, particularly in light of the significant uncertainty inherent in developing therapeutics and vaccines against bioterror threats, conducting preclinical and clinical trials of therapeutics and vaccines, obtaining regulatory approvals and manufacturing therapeutics and vaccines, that product development and commercialization efforts will not be reduced or discontinued due to difficulties or delays in clinical trials or due to lack of progress or positive results from research and development efforts, that it will be able to successfully obtain any further funding to support product development and commercialization efforts, including grants and awards, maintain its existing grants which are subject to performance requirements, enter into any biodefense procurement contracts with the
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FAQ
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