T-cell Malignancies - Pipeline Insight, 2025

This “T-cell Malignancies - Pipeline Insight, 2025” report provides comprehensive insights about 80+ companies and 82+ pipeline drugs in T-cell Malignancies 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.

T-cell Malignancies: Understanding

T-cell Malignancies: Overview

T-cell malignancies are a diverse group of rare and aggressive cancers that arise from the T-cells, a subset of white blood cells responsible for cell-mediated immunity. The etiology of T-cell malignancies is complex and multifactorial, with various genetic and environmental factors contributing to their development. Genetic abnormalities, such as dysregulation of genes like cancer-testis genes, B lymphoid tyrosine kinase, and signaling pathways like Jak-3/STAT and NOTCH1, can lead to the development of T-cell lymphoma. Additionally, infectious etiology, including viral infections like Human T-cell leukemia virus (HTLV)1 and HTLV2, HIV, EBV, CMV, and HHV8, have been linked to T-cell lymphoma, particularly adult T-cell lymphoma/leukemia and natural-killer cell/T-cell lymphoma. Chronic inflammation, such as chronic cutaneous inflammation, and a family history of myeloma also increase the risk of T-cell lymphoma. Furthermore, autoimmune disorders can contribute to the development of T-cell lymphoma. These factors can lead to the clonal expansion of T-cells, which can result in the formation of T-cell lymphomas.

T-cell malignancies, including T-cell lymphoma and leukemia, exhibit a range of signs and symptoms depending on the specific type and stage of the disease. Common symptoms include swollen lymph nodes, fever, night sweats, weight loss, fatigue, and skin rashes or itching. In some cases, patients may experience bleeding or bruising easily, recurrent infections, and persistent abdominal pain due to a swollen spleen. The skin can be affected in various ways, such as patches of flat, scaly skin, thick, raised plaques, or tumors that may develop into ulcers. Additionally, patients may experience symptoms like labored breathing and swelling in the arms and face, particularly in T-lymphoblastic lymphoma/leukemia. The symptoms can vary depending on the specific type of T-cell lymphoma, such as mycosis fungoides, Sézary syndrome, or adult T-cell leukemia/lymphoma, and can include red, itchy rashes, changes to nails and hair, and enlarged lymph nodes.

Treatment and management of T-cell malignancies involve a multidisciplinary approach, combining various therapies to achieve optimal outcomes. For T-cell lymphomas, chemotherapy is often the primary treatment, with regimens such as cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) being commonly used. In some cases, targeted therapies like anti-CD30 CAR-T cells have shown promising results, particularly in relapsed Hodgkin lymphoma. For T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LBL), chemotherapy is typically the recommended treatment, especially if the disease has not spread to the bone marrow at diagnosis. Cutaneous T-cell lymphoma (CTCL) treatment focuses on managing skin symptoms, often involving topical corticosteroids, phototherapy, and systemic therapies like bexarotene. Adult T-cell leukemia/lymphoma (ATL) treatment usually involves a combination of chemotherapy, immunotherapy, and antiviral therapy to manage the underlying HTLV-1 infection. Angioimmunoblastic T-cell lymphoma (AITL) treatment often involves cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy, with alternative approaches being evaluated due to poor outcomes. Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS), is often treated with CHOP chemotherapy, with novel agents being explored for relapsed cases. Effective management of T-cell malignancies also involves addressing toxicities, such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), which can occur with CAR-T cell therapies.

'T-cell Malignancies - Pipeline Insight, 2025' report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the T-cell Malignancies pipeline landscape is provided which includes the disease overview and T-cell Malignancies treatment guidelines. The assessment part of the report embraces, in depth T-cell Malignancies 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, T-cell Malignancies 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 T-cell Malignancies R&D. The therapies under development are focused on novel approaches to treat/improve T-cell Malignancies.

T-cell Malignancies Emerging Drugs Chapters

This segment of the T-cell Malignancies report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II/III, 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.

T-cell Malignancies Emerging Drugs

Masitinib: AB Science

Masitinib is a new orally administered tyrosine kinase inhibitor that targets mast cells and macrophages, important cells for immunity, through inhibiting a limited number of kinases. Based on its unique mechanism of action, masitinib can be developed in a large number of conditions in oncology, in inflammatory diseases, and in certain diseases of the central nervous system. In oncology due to its immunotherapy effect, masitinib can have an effect on survival, alone or in combination with chemotherapy. The drug is currently being evaluated under Phase III clinical trial for the treatment of patients with T-cell malignancies.

Soquelitinib: Corvus Pharmaceuticals

Soquelitinib (formerly known as CPI-818) is an investigational small molecule drug given orally designed to selectively inhibit ITK (interleukin-2-inducible T cell kinase), an enzyme that is expressed predominantly in T cells and plays a role in T cell and natural killer (NK) cell immune function. The drug is currently being evaluated under Phase II clinical trial for the treatment of patients with T-cell malignancies.

Golcadomide: Bristol-Myers Squibb

Golcadomide is a novel, oral CELMoD agent representing one of several compelling assets generated from our differentiated targeted protein degradation research platform. The drug is currently being evaluated under Phase I/II clinical trial for the treatment of patients with T-cell malignancies.

KT-333: Kymera Therapeutics

KT-333 is a potent, highly selective degrader of STAT3 in development for the treatment of multiple STAT3-dependent pathologies, including hematological malignancies and solid tumors. STAT3 is an undrugged transcription factor activated through a variety of different cytokine and growth factor receptors via Janus kinases (JAKs), as well as through oncogenic fusion proteins and mutations in STAT3 itself. In certain malignant cells, STAT3 activation is set into overdrive, leading to a dampened immune response, tumor progression, and metastasis. The drug is currently being evaluated under Phase I clinical trial for the treatment of patients with T-cell malignancies.

NXD02: neoX Biotech

NeoX developed NXD02, to improve the therapeutic window by mitigating platelet toxicity through neoX’s AI-empowered degrader design platform, neoDegrader. The drug is currently in the Preclinical stage of development for the treatment of patients with T-cell Malignancies.

T-cell Malignancies: Therapeutic Assessment

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

Major Players in T-cell Malignancies

There are approx. 80+ key companies which are developing the therapies for T-cell Malignancies. The companies which have their T-cell Malignancies drug candidates in the most advanced stage, i.e. Phase III include, AB Science.

Phases

The report covers around 82+ 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

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

• Intravenous
• Subcutaneous
• Oral
• Intramuscular

Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal antibody
• Small molecule
• Peptide

Product Type

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

T-cell Malignancies: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses T-cell Malignancies 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 T-cell Malignancies drugs.

T-cell Malignancies Report Insights

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

T-cell Malignancies 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 T-cell Malignancies drugs?
• How many T-cell Malignancies drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of T-cell Malignancies?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the T-cell Malignancies 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 T-cell Malignancies and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• AB Science
• Corvus Pharmaceuticals
• Bristol-Myers Squibb
• Kymera Therapeutics
• neoX Biotech
• Jiangsu Hengrui Medicine
• Soligenix
• Equillium
• Janssen Biotech
• Ono Pharmaceutical
• Artiva Biotherapeutics
• Dialectic Therapeutics
• Nutcracker Therapeutics
• FutureGen Biopharmaceutical
• Step Pharma
• Merck & Co

Key Products

• Masitinib
• Soquelitinib
• Golcadomide
• KT-333
• NXD02
• SHR-2554
• Hypericin
• EQ-101
• Daratumumab
• ONO-4685
• AB-205
• DT-2216
• NTX-565
• M-131
• Dencatistat
• Pembrolizumab

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