Cutaneous T-Cell Lymphoma (CTCL) - Pipeline Insight, 2024

This “Cutaneous T-Cell Lymphoma (CTCL)- Pipeline Insight, 2024” report provides comprehensive insights about 30+ companies and 35+ 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

Malignant lymphomas can present in the skin either as a primary or secondary manifestation of the disease. The term primary cutaneous lymphoma (PCL) refers to a heterogeneous group of cutaneous T-cell lymphomas (CTCLs) and cutaneous B-cell lymphomas (CBCLs).

According to National Organization for Rare Disorders (NORD), CTCLs are a group of disorders characterized by abnormal accumulation of malignant T-cells in the skin, potentially resulting in the development of rashes, plaques, and tumors, and the localization of neoplastic T lymphocytes to the skin. Collectively, CTCL is classified as a type of non-Hodgkin lymphoma (NHL). Cutaneous T-cell lymphomas (CTCL) are the most common types of skin lymphoma. More than three out of every four skin lymphomas diagnosed are CTCLs and often appear as eczema-like skin rashes and can affect widespread parts of the body. There are different subtypes of CTCL. CTCLs are characterized by the recruitment of malignant T-cell clones into the skin. Mycosis fungoides (MF) represent the most common type of CTCL and account for ~50% of all primary cutaneous lymphomas, followed by Sézary syndrome.

The most common type is mycosis fungoides. In some cases, CTCL can affect more than just the skin and cause the formation of tumors, exfoliation, and ulceration accompanied by infections and itching. In the advanced stages, CTCL begins to extend to lymph nodes, internal organs, and peripheral blood.

Cutaneous T-cell lymphomas (CTCLs) result from errors in the production of T-lymphocytes or the transformation of T-lymphocytes into malignant cells. In CTCLs, abnormal, uncontrolled growth and multiplication (proliferation) of malignant T-lymphocytes result in the accumulation of these lymphocytes in the skin. In some cases, malignant lymphocytes may spread to affect the lymph nodes and eventually to other bodily tissues and organs, potentially resulting in life-threatening complications.

The specific symptoms and physical findings may vary from case to case, depending upon the extent and region(s) of involvement, the specific type of CTCL present, and various additional factors. Non-Hodgkin’s lymphomas, such as CTCLs, may also be categorized based upon certain characteristics of the cancer cells as seen under a microscope and how quickly they may tend to grow and spread. For example, CTCLs may be characterized as “low-grade” (or indolent) lymphomas, which tend to grow slowly and result in few associated symptoms, or “intermediate-grade” or “high-grade” (aggressive) lymphomas, which typically grow rapidly, requiring prompt treatment. Most cases of CTCL, especially the classic form (mycosis fungoides), are slow-growing (indolent) lymphomas. CTCL is not a life-threatening disease, and mostly, it can be treated but not cured.

Cutaneous T-Cell Lymphoma- Pipeline Insight, 2024 report 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

SHP-141: MedivirRemetinostat is a histone deacetylase (HDAC) inhibitor. HDAC inhibitors are approved for the treatment of MF-CTCL in late-stage patients but are not recommended for early-stage patients due to their significant side effects. The unique design of remetinostat enables topical application, making it active only in the skin. As soon as it reaches the bloodstream, it is degraded, avoiding the side effects of other HDAC inhibitors. In December 2018, Medivir had clarifying and positive discussions with the FDA about the Phase III program design for MF-CTCL. One successful phase III study is expected to be sufficient for market approval to treat patients with early-stage MF-CTCL. Medivir intends to seek a partner for the continued development and commercialization of remetinostat.

Resminostat: 4SCResminostat (4SC-201), 4SC's lead oncology compound, is an oral histone-deacetylase (HDAC) inhibitor with an innovative epigenetic mechanism of action that potentially enables the compound to be deployed as a novel, targeted tumour therapy for a broad spectrum of oncological indications in particular in combination with other cancer drugs. Resminostat is a potent inhibitor of class I, IIb, and IV HDACs, including a pronounced activity against HDAC6. In pharmacology studies, resminostat dose-dependently inhibited HDACs and induced acetylation of histone and non-histone proteins resulting in changes in gene expression levels in tumor cells and the deregulation of pathways involved in cell differentiation, such as WNT signaling. A Phase II clinical trial is being evaluated in the treatment of patients with Cutaneous T-cell lymphoma.

MT-101: Myeloid TherapeuticsMT-101 is the first mRNA engineered CAR monocyte (CAR-M) derived from the Company’s proprietary ATAK™ platform.MT-101 targets CD5, a surface receptor present in many T cell malignancies. MT-101 is being developed for the treatment of relapsed and refractory CD5-expressing T cell lymphomas. Refractory PTCL is a lethal disease with limited treatment options that until now has not benefited from innovations in cell therapy. In vitro and in vivo studies show MT-101 demonstrated meaningful anti-tumor activity. Treatment in these models has been associated with potent phagocytosis responses, the production of inflammatory mediators and delays in tumor progression. Currently, the drug is in Phase I/II stage of its development for the treatment of CTCL.

Tinostamustine: Mundipharma InternationalTinostamustine (EDO-S101) is an inhibitor of the alkylating deacetylase enzyme, and is designed to have potent toxic effects against cancer cells by integrating multiple modes of action. Preclinical studies revealed that tinostamustine improves access to DNA strands within cancer cells, both by breaking them and counteracting the cells’ mechanisms to repair this damage. It is a multi-action therapy and is currently in Phase I clinical trials for CTCL.

B006: Shanghai Pharmaceuticals HoldingB006, is a recombinant human-mouse chimeric anti-CD30 monoclonal antibodyMCC-DM1 coupling agent for injection with independent intellectual property rights, and is intended for anaplastic large cell lymphoma, Hodgkin’s lymphoma and cutaneous T-cell lymphoma. Currently the drug is in Preclinical stage of development for the treatment of Cutaneous T-cell lymphoma.

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. 30+ 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. phase II include, Medivir.

Phases

This report covers around 35+ 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

• Medivir
• 4SC
• Myeloid Therapeutics
• Mundipharma International
• Shanghai Pharmaceuticals Holding
• Soligenix
• Affimed GmbH
• Merck & Co., Inc.
• Philogen S.p.A.
• Innate Pharma
• Hoffman-La-Roche
• Galderma
• Vidac Pharma
• BeiGene
• Otsuka Pharmaceutical

Key Products

• SHP-141
• Resminostat
• MT-101
• Tinostamustine
• B006
• SGX 301
• Pembrolizumab
• AFM13
• Nidlegy
• Lacutamab
• Atezolizumab
• CD11301
• VDA-1102
• Tislelizumab
• ASTX660

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