Promising Treatment for Cutaneous T-cell Lymphoma Enters Clinical Trials

Los Angeles, USA, Aug. 03, 2021 (GLOBE NEWSWIRE) — Promising Treatment for Cutaneous T-cell Lymphoma Enters Clinical Trials  

Around 25+ key companies are developing Cutaneous T-Cell Lymphoma therapies, of which Soligenix has the drug candidate in the most advanced stage (Phase III).

DelveInsight’s “Cutaneous T-cell Lymphoma (CTCL) Pipeline Insight” report provides comprehensive insights about 25+ companies and 25+ pipeline drugs in the Cutaneous T-cell Lymphoma pipeline landscapes. It comprises CTCL pipeline drug profiles, including clinical and non-clinical stage products. It also includes the Cutaneous T-cell Lymphoma therapeutics assessment by product type, stage, route of administration, and molecule type and further highlights the inactive CTCL pipeline products.     

Some of the key takeaways from the Cutaneous T-cell Lymphoma Pipeline Report  

• Major companies such as Merck Sharp & Dohme Corp., Elorac, Soligenix, 4SC AG, Innate Pharma, Viridian Therapeutics, Sorrento Therapeutics, Bio-Path Holdings, Inc., Legend Biotech USA Inc., Genzada Pharmaceuticals, VidacPharma, MedC Biopharma, Galderma, Moleculin Biotech, Bioniz Therapeutics, Otsuka Pharmaceutical, BeiGene, Hoffmann-La Roche, BioInvent International AB, Mundipharma-EDO GmbH, SciTech Development, Trillium Therapeutics Inc., Scopus BioPharma, Applied Therapeutics, Brickell Biotech Inc., Codiak BioSciences, and others are developing potential drug candidates to improve the Cutaneous T-cell Lymphoma treatment scenario. 
• In January 2021, Soligenix, Inc. announced that it had signed an exclusive Supply, Distribution, and Services Agreement with Daavlin. Securing long-term supply and distribution of a commercially ready light device is an integral component of the regulatory and commercial strategy for SGX301 (synthetic hypericin) to treat Cutaneous T-cell Lymphoma. 
• In June 2021, Soligenix, Inc., announced that it had received a Pediatric Investigation Plan (PIP) waiver from the European Medicines Agency (EMA) for HyBryte™ (SGX301 or hypericin).
• SGX301 has secured orphan drug and fast track designations from the US Food and Drug Administration and an orphan designation from the European Medicines Agency.
• In May 2021, Soligenix announced that HyBryte™ (hypericin) was awarded an “Innovation Passport” for the treatment of early-stage cutaneous T-cell lymphoma (CTCL) in adults under the United Kingdom’s (UK’s) Innovative Licensing and Access Pathway (ILAP).
• In May 2017, miRagen Therapeutics announced that the European Commission (EC) granted orphan medicinal product designation to miRagen’s product candidate, MRG-106, to treat Cutaneous T-cell Lymphoma. 
• In April 2021, Bioniz Therapeutics announced that the European Commission (EC) had granted orphan designation to BNZ-1 to treat cutaneous T-cell lymphoma (CTCL).
• BBI-3000 is a highly selective, potentially safer, and potent RXR retinoid currently under development for retinoid responsive skin conditions. While the company believe there are several skin indications where a novel RXR retinoid agonist could be developed, they are currently focusing our development of BBI-3000 as a potential oral treatment for subjects with cutaneous t-cell lymphoma (CTCL),

Get an overview of pipeline landscape @ Cutaneous T-cell Lymphoma Clinical Trials Analysis 

Cutaneous T-cell Lymphoma (CTCL) is a rare type of cancer that begins in white blood cells called T cells (T lymphocytes). These cells usually help the body’s germ-fighting immune system. 

Cutaneous T-cell Lymphoma Emerging Drugs

SGX301 is a novel first-in-class photodynamic therapy utilizing safe, visible light for activation.  The active ingredient in SGX301 is synthetic hypericin, a potent photosensitizer that is topically applied to skin lesions, is taken up by the malignant T-cells, and then activated by fluorescent light 16 to 24 hours later.  Currently, it is in the Phase III stage of clinical trial evaluation.

Research and Development
NCT02448381: In December 2015, Soligenix initiated a Phase III multicenter, randomized, double-blind, placebo-controlled study to determine the efficacy of topical SGX301 (Synthetic Hypericin) and Fluorescent Bulb-Light Irradiation for the Treatment of Cutaneous T-Cell Lymphoma. The Phase III FLASH trial enrolled a total of 169 patients (166 evaluable) with Stage IA, IB, or IIA CTCL. The trial consists of three treatment cycles. The Phase III CTCL clinical study was partially funded by the National Cancer Institute via a Phase II SBIR grant (#1R44CA210848-01A1) awarded to Soligenix, Inc.

Results
In October 2020, Soligenix announced that continued optional treatment with SGX301 (synthetic hypericin) across all lesions during the compassionate use, safety portion of the trial (Cycle 3), for a total of 6 months in the study, continued to enhance responses significantly and remained safe and well-tolerated in its FLASH (Fluorescent Light Activated Synthetic Hypericin) study.  This data reinforces the positive SGX301 primary endpoint treatment response demonstrated in Cycle 1. SGX30l treatment in Cycle 3 further enhanced response rates, with 49% of patients electing to receive SGX301 for a total of 18 weeks demonstrating a 50% or more significant reduction in their combined CAILS (Composite Assessment of Index Lesion Score) lesion score compared to 40% of patients showing such a reduction after completing 12 weeks of SGX301 treatment in Cycle 2 (p=0.046).

• WP1220: Moleculin Biotech

WP1220 is a STAT3 transcription factor inhibitor being developed by Moleculin Biotech to treat CTCL. Preclinical research in multiple cutaneous T-cell lymphoma (“CTCL”) cell lines has suggested that WP1220 may effectively inhibit CTCL. Based on this data, the company collaborated with a Polish drug development company that has received Polish government grant money to develop WP1220 in Poland for the topical treatment of early-stage CTCL patients. CTCL is a potentially deadly form of skin cancer for which there are limited treatment options. The company Moleculin Biotech plans a phase II in Cutaneous T-cell lymphoma in the year 2021

Research and Development
NCT04702503: In March 2019, Moleculin Biotech initiated a Phase Ib Study Evaluating the Safety and Efficacy of Topical Administration of WP1220, an Inhibitor of STAT3 Activation, in Adults With Stage I, II, or III Mycosis Fungoides (Cutaneous T-Cell Lymphoma, CTCL). The trial got completed in November 2020.

• MDC-2021: MedC Biopharma Corporation

MedC Biopharma Corporation is developing MDC-2021 for the treatment of Cutaneous T-cell Lymphoma. It is currently in the preclinical stage of development.

• BNZ 1: Bioniz Therapeutics

BNZ-1 is a selective inhibitor of three members of the IL-2 family: IL-2, IL-9, and IL-15. The profile of BNZ-1 is promising as a long-term therapy capable of transforming the standard of care in CTCL as data demonstrates the dysregulation of IL-2/IL-9/IL-15 as responsible for disease pathology. Bioniz conducted a Phase 1/2 study in CTCL, in which BNZ-1 exhibited a major improvement in safety and efficacy relative to standard of care. On the strength of these results, the company plans to initiate a Phase III trial in the second half of 2021.

Research and Development
NCT03239392: In April 2018, Bioniz Therapeutics initiated a dose-ranging study of Intravenous BNZ132-1-40 in patients with Large Granular Lymphocyte Leukemia or Refractory Cutaneous T-Cell Lymphoma. This study was an open-label, multi-centre, dose-ranging study to characterize the safety, tolerability, preliminary efficacy, and PK/PD of up to four dose levels of BNZ-1 administered weekly by IV infusion to adults diagnosed with LGL or CTCL. The trial got completed in June 2020.

Results
Overall, BNZ-1 was well tolerated and showed no treatment-related severe adverse events in this patient population. Furthermore, PD analysis revealed that BNZ-1 discernibly suppressed the inflammatory nature of CTLs in the majority of patients that respond to BNZ-1 treatment as measured by reduction in their mSWAT scores.
The multifaceted approach of BNZ-1 leads to direct inhibition of malignant cells, activation of tumour immunity, and suppression of inflammation. Since BNZ-1 showed safety and efficacy in challenging the rCTCL patient population, further development in a phase III trial is planned.

For further information, refer to the detailed report @ Cutaneous T-cell Lymphoma Pipeline Therapeutics 

Scope of Cutaneous T-cell Lymphoma Pipeline Drug Insight    

• Coverage: Global 
• Major Players: 25+ Key Players
• Prominent Players: Merck Sharp & Dohme Corp., Elorac, Soligenix, 4SC AG, Innate Pharma, Viridian Therapeutics, Sorrento Therapeutics, Bio-Path Holdings, Inc., Legend Biotech USA Inc., Genzada Pharmaceuticals, VidacPharma, MedC Biopharma, Galderma, Moleculin Biotech, Bioniz Therapeutics, Otsuka Pharmaceutical, BeiGene, Hoffmann-La Roche, BioInvent International AB, Mundipharma-EDO GmbH, SciTech Development, Trillium Therapeutics Inc., Scopus BioPharma, Applied Therapeutics, Brickell Biotech Inc., Codiak BioSciences, and others
• Key Drugs Profiles: 25+ Products
• Phases:  

·       Cutaneous T-cell Lymphoma Therapies Late-stage (Phase III)  
·       CTCL Therapies Mid-stage (Phase II)
·       Cutaneous T-cell Lymphoma Therapies Early-stage (Phase I) 
·       CTCL Pre-clinical stage and Discovery candidates     
·       Discontinued and Inactive candidates  

·      STAT3 transcription factor inhibitors
·      Protein kinase C inhibitors
·      Interleukin 15 receptor antagonists
·      Cannabinoid receptor modulators

·     Gene therapy 
·     Monoclonal Antibody
·     Peptides 
·     Polymer
·     Small molecule    
·     Vaccines 

·      Infusion
·      Intradermal
·      Intramuscular
·      Parenteral
·      Topical 
·      Intranasal
·      Oral
·      Subcutaneous 

·       Monotherapy
·       Combination
·       Mono/Combination 

Key Questions regarding Current Cutaneous T-cell Lymphoma Treatment Landscape and Emerging Therapies Answered in the Pipeline Report  

• What are the current options for CTCL treatment?
• How many companies are developing therapies for the treatment of Cutaneous T-cell Lymphoma? 
• How many are CTCL emerging therapies in the early-stage, mid-stage, and late development stages to treat Cutaneous T-cell Lymphoma? 
• Which are the dormant and discontinued products and the reasons for the same?
• What is the unmet need for current therapies for the treatment of Cutaneous T-cell Lymphoma?  
• What are the current novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing CTCL therapies? 
• What are the critical designations that have been granted for the emerging therapies for Cutaneous T-cell Lymphoma? 
• How many patents are granted and pending for the emerging therapies to treat Cutaneous T-cell Lymphoma?   

Table of Contents

Get a customized pipeline report @ Cutaneous T-cell Lymphoma Drugs Pipeline Report  

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