Cutaneous T-cell lymphoma - Pipeline Insight, 2025

DelveInsight’s, “Cutaneous T-cell lymphoma- Pipeline Insight, 2025” report provides comprehensive insights about 25+ companies and 30+ pipeline drugs in Cutaneous T-cell lymphoma pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Cutaneous T-cell lymphoma: Understanding

Cutaneous T-cell lymphoma: Overview

Cutaneous T-cell lymphoma (CTCL) is a rare type of non-Hodgkin lymphoma that primarily affects the skin. It originates from T-cells, a type of white blood cell that plays a critical role in the immune system. In CTCL, these T-cells become malignant and migrate to the skin, where they cause patches, plaques, or tumors. The disease typically progresses slowly, and early stages may resemble common skin conditions such as eczema or psoriasis, making diagnosis challenging. The two most common subtypes of CTCL are mycosis fungoides and Sézary syndrome, though there are several other, less common forms.

Mycosis fungoides is the most prevalent form of CTCL and typically presents as red, scaly patches or plaques on the skin, often on areas not exposed to the sun. These lesions may be itchy and evolve over time, becoming more extensive or even leading to tumor formation in later stages. Sézary syndrome, on the other hand, is a more aggressive and advanced form of CTCL characterized by widespread skin involvement, redness (erythroderma), and the presence of malignant T-cells in the blood. Sézary syndrome often presents with systemic symptoms like swollen lymph nodes and pruritus (severe itching).

The exact cause of CTCL remains unknown, but it is thought to involve a combination of genetic and environmental factors that lead to the abnormal proliferation of T-cells. In some cases, chronic antigen stimulation, viral infections, or exposure to certain chemicals have been considered as potential triggers. CTCL is more common in older adults, particularly males, and the risk increases with age. While it is not considered hereditary, some genetic predispositions may play a role in its development.

Treatment options for CTCL vary depending on the stage and type of the disease. Early-stage treatments may include topical therapies like corticosteroids, retinoids, or phototherapy (light-based treatments). In more advanced cases, systemic therapies such as chemotherapy, biologic agents, or stem cell transplantation may be required. In recent years, novel therapies like monoclonal antibodies and targeted therapies have emerged, providing hope for better disease control and improved quality of life for patients.

Despite being a chronic condition, many patients with early-stage CTCL can live for years with minimal impact on their overall health. However, for those with advanced disease or aggressive subtypes, the prognosis can be more severe, with a higher risk of complications and a reduced life expectancy. Continuous research is ongoing to better understand the disease mechanisms and to develop more effective treatments, improving both survival rates and the quality of life for CTCL patients.

""Cutaneous T-cell lymphoma- Pipeline Insight, 2025"" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Cutaneous T-cell lymphoma pipeline landscape is provided which includes the disease overview and Cutaneous T-cell lymphoma treatment guidelines. The assessment part of the report embraces, in depth Cutaneous T-cell lymphoma commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Cutaneous T-cell lymphoma collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence Cutaneous T-cell lymphoma R&D. The therapies under development are focused on novel approaches to treat/improve Cutaneous T-cell lymphoma.

Cutaneous T-cell lymphoma Emerging Drugs Chapters

This segment of the Cutaneous T-cell lymphoma report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Cutaneous T-cell lymphoma Emerging Drugs

• HyBryte: Soligenix

HyBryte™ (synthetic hypericin or 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 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. Synthetic hypericin sodium, the active ingredient in HyBryte™, has Orphan Drug designation in the United States for the treatment of T-cell lymphoma and CTCL and in Europe for CTCL. HyBryte™ has received Fast Track designation for the treatment of cutaneous t-cell lymphoma in the United States.

• AFM13: Affimed GmbH

AFM-13 is under development for the treatment of refractory and relapsed Hodgkin lymphoma, CD30+ lymphoma such as transformed mycosis fungoides, peripheral and cutaneous T-cell lymphoma, large B-cell lymphoma, B-cell non-Hodgkin lymphoma, Hodgkin lymphoma combination with check point inhibitors and Hodgkin lymphoma combination with lenalidomide. The drug candidate is administered intravenously. AFM-13 is a bi-specific, tetravalent human antibody, it acts by targeting CD30/CD16A. The drug is currently in Phase II stage of its development for the treatment of Cutaneous T Cell Lymphoma.

• ASTX660: Otsuka Pharmaceutical Co., Ltd

ASTX660 (Tolinapant) is a novel, orally administered, non-peptidomimetic antagonist of the cellular and X-linked inhibitors of apoptosis proteins (cIAP1/2 and XIAP). Inhibitors of apoptosis proteins (IAPs) are frequently overexpressed in tumor cells and contribute to tumor cell survival and chemo-resistance. By inhibiting IAPs, tolinapant promotes cell death. Tolinapant also acts via a newly described immunomodulatory mechanism, which works to enhance an anti-tumor immune response in T-cell lymphomas. The drug is in Phase I/II for the treatment of CTCL.

• WUCART007: Wugen

WU-CART-007 is an allogeneic, off-the-shelf, fratricide-resistant CD7-targeted CAR-T cell therapy engineered to overcome the technological challenges of harnessing CAR-T cells to treat CD7+ hematological malignancies. Wugen is deploying CRISPR/Cas9 gene editing technology to delete CD7 and the T-cell receptor alpha constant (TRAC), preventing CAR-T cell fratricide and mitigating the risk of graft-versus-host-disease (GvHD). WU-CART-007 is manufactured using healthy donor-derived T-cells to eliminate the risk of malignant cell contamination historically observed in the autologous CAR-T setting. Currently, the drug is in Phase I stage of its clinical trial for the treatment of CTCL.

Further product details are provided in the report……..

Cutaneous T-cell lymphoma: Therapeutic Assessment

This segment of the report provides insights about the different Cutaneous T-cell lymphoma drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Cutaneous T-cell lymphoma
• There are approx. 25+ key companies which are developing the therapies for Cutaneous T-cell lymphoma. The companies which have their Cutaneous T-cell lymphoma drug candidates in the most advanced stage, i.e. Preregistration include, Soligenix.
• Phases

DelveInsight’s report covers around 30+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Cutaneous T-cell lymphoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Cutaneous T-cell lymphoma: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Cutaneous T-cell lymphoma therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Cutaneous T-cell lymphoma drugs.

Cutaneous T-cell lymphoma Report Insights

• Cutaneous T-cell lymphoma Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Cutaneous T-cell lymphoma Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Cutaneous T-cell lymphoma drugs?
• How many Cutaneous T-cell lymphoma drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Cutaneous T-cell lymphoma?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Cutaneous T-cell lymphoma therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Cutaneous T-cell lymphoma and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• HyBryte
• Resminostat
• Mundipharma International
• Shanghai Pharmaceuticals Holding
• Moleculin Biotech, Inc.
• BeiGene
• Mundipharma Research Limited
• Jiangsu Simcere Biologics Co., Ltd
• Teva Pharmaceuticals USA
• Pfizer
• Galderma R&D
• Merck Sharp & Dohme LLC
• Bio-Path Holdings, Inc.
• Kymera Therapeutics, Inc.
• Karyopharm Therapeutics Inc

Key Products

• Soligenix
• 4SC AG
• Tinostamustine
• B006
• WP1220
• Tislelizumab
• Tinostamustine
• SIM1811-03
• Romidepsin
• Ritlecitinib
• CD11301
• Pembrolizumab
• L-Bcl-2 antisense oligonucleotide
• KT-333
• KPT-330

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