Diffuse Large B-Cell Lymphoma - Pipeline Insight, 2024

This “Diffuse Large B-Cell Lymphoma - Pipeline Insight, 2024” report provides comprehensive insights about 70+ companies and 75+ pipeline drugs in the Diffuse Large B-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

Diffuse Large B-Cell Lymphoma: Understanding

Diffuse Large B-Cell Lymphoma: Overview

Diffuse large B cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma, accounting for approximately 25% to 30% of all cases. It typically presents as rapidly enlarging lymph nodes or masses, either nodal or extranodal. DLBCL arises from malignant proliferation of B cells, often originating from germinal center B cells. Genetic mutations, chronic immunodeficiency, and certain infectious agents such as Epstein-Barr virus can contribute to its development. DLBCL is heterogeneous, with various molecular subtypes identified through gene expression profiling. The pathophysiology involves dysregulation of BCL2, BCL6, and MYC genes, among others. Treatment typically involves immunochemotherapy regimens such as R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone), with the choice of therapy influenced by molecular subtype and clinical staging. Despite its aggressive nature, DLBCL can achieve long-term remission with appropriate treatment, highlighting the importance of early diagnosis and multidisciplinary management. Symptoms of diffuse large B cell lymphoma (DLBCL) can vary but commonly include rapidly enlarging lymph nodes or masses, often presenting as nodal or extranodal involvement. Patients may experience B symptoms such as fever, night sweats, and weight loss, occurring in approximately 30% of cases. Bone marrow involvement is common, seen in up to 50% of patients, while extranodal involvement occurs in about 50% of cases. DLBCL can manifest with symptoms related to compression of adjacent structures, such as superior vena cava syndrome or airway obstruction, particularly in cases of extranodal disease infiltration. Additionally, systemic symptoms (B-symptoms) may result from increased cytokine production. The presentation varies depending on whether the subtype is aggressive or indolent, with aggressive variants typically presenting as rapidly growing masses, while indolent lymphomas may develop more slowly with intermittent or progressive lymphadenopathy.

The diagnosis of diffuse large B cell lymphoma (DLBCL) involves a comprehensive approach including clinical evaluation, laboratory tests, imaging studies, and tissue biopsy. A thorough history and physical examination are essential, focusing on symptoms such as rapidly enlarging lymph nodes, B symptoms (fever, night sweats, weight loss), and signs of extranodal involvement. Laboratory tests typically include a complete blood count with differential, comprehensive metabolic panel, lactate dehydrogenase (LDH) levels, and HIV and hepatitis serologies. Imaging studies, such as positron emission tomography (PET) and computed tomography (CT), are crucial for staging the disease and identifying the extent of involvement. However, the definitive diagnosis of DLBCL relies on tissue biopsy, preferably through an excisional lymph node biopsy rather than fine-needle aspiration, to allow for histologic and immunophenotypic analysis. Immunohistochemistry staining for B cell markers, along with flow cytometry and genetic studies, help confirm the diagnosis and characterize the molecular subtype of DLBCL.

Standard treatment for DLBCL is R-CHOP regimen, comprising rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone. High-risk features may necessitate alternative or intensified regimens like R-CHOP combined with lenalidomide or bortezomib. Indolent lymphomas may undergo watchful waiting, radiotherapy, or chemotherapy, while high-grade lymphomas require aggressive chemotherapy with CNS prophylaxis. Supportive care is crucial to manage treatment-related complications, and decisions should involve a multidisciplinary team for optimal outcomes.

"Diffuse Large B-Cell Lymphoma- Pipeline Insight, 2024" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Diffuse Large B-Cell Lymphoma pipeline landscape is provided which includes the disease overview and Diffuse Large B-Cell Lymphoma treatment guidelines. The assessment part of the report embraces, in depth Diffuse Large B-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, Diffuse Large B-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 Diffuse Large B-Cell Lymphoma R&D. The therapies under development are focused on novel approaches to treat/improve Diffuse Large B-Cell Lymphoma.

Diffuse Large B-Cell Lymphoma Emerging Drugs Chapters

This segment of the Diffuse Large B-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.

Diffuse Large B-Cell Lymphoma Emerging Drugs

• Brentuximab vedotin: Pfizer

Brentuximab vedotin (Adcetris) is an anti-neoplastic agent. It is indicated for the treatment of patients with Classical Hodgkin lymphoma (HL) after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates. Adcetris is also indicated for the treatment of adult patients with CD30+ Hodgkin lymphoma at increased risk of relapse or progression following autologous stem cell transplant (ASCT), also indicated for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma, for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) and CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy, for the treatment of adult patients with relapsed or refractory CD30+ cutaneous T- cell lymphoma (CTCL) after at least 1 prior systemic therapy. Adcetris is indicated for the first-line pediatric treatment for CD30-positive Hodgkin lymphoma. Currently, the drug is in Phase III stage of its clinical trial for the treatment of Diffuse Large B Cell Lymphoma.

• THOR-707: Sanofi

THOR-707 is a precisely PEGylated version of IL-2, where the PEG chain is attached to a novel amino acid inserted at a location on IL-2 that prevents it from engaging the alpha-receptor and binding to immune receptors that cause drug toxicities (IL-2R-alpha, CD25). The engineered IL-2 retains near-native binding to the beta-gamma receptors that selectively expand tumor-killing T effector cells and Natural Killer (NK) cells without the alpha-mediated immunosuppressive effects of regulatory T cells or eosinophil-mediated vascular leak syndrome. Currently, the drug is in Phase II stage of its clinical trial for the treatment of Diffuse Large B Cell Lymphoma.

• Abexinostat: Xynomic Pharmaceuticals

Abexinostat (Xynomic Pharmaceuticals) is a broad histone deacetylase (HDAC) inhibitor. HDAC enzymes (also known as lysine deacetylase) cleave acetyl groups from N-acetyl lysine amino acids on a histone. HDAC inhibition leads to highly acetylated histones and chromatin reshaping. In addition to altering histone acetylation, HDAC inhibitors can also influence the degree of acetylation on non-histone proteins, increasing or repressing their activity. Currently, the drug is in Phase II stage of its clinical trial for the treatment of Diffuse Large B-cell lymphoma.

• RNK05047: Ranok Therapeutics

RNK05047 is a first-in-class, small-molecule, tumor- and BRD4-selective protein degrader that was discovered and developed using Ranok’s proprietary approach to targeted protein degradation, CHAMPTM. The bromodomain transcription factor BRD4 is a key regulator of oncogenes such as MYC and BCL2 and is involved in diverse cancer types. CHAMP-1 is a Phase I/II trial of RNK05047 currently underway in the US that will assess its safety, tolerability, and pharmacokinetics, and also includes measures of anti-tumor activity and pharmacodynamics readouts as secondary endpoints.

• BMF-219: Biomea Fusion

BMF-219 is an oral investigational covalent menin inhibitor. Data suggests that optimized covalent inhibitors can provide deeper inhibition while being better tolerated than some conventional reversible inhibitors. BMF-219 is being developed for genetically defined AML, ALL, DLBCL, MM and CLL patients. BMF-219 blocks the interaction of menin and MLL (AML, ALL), and limits the activity and/or expression of NPM1, MYC, HOX, and MEIS1, all known drivers of oncogenic proliferation and survival. Currently, the drug is in Phase I stage of its clinical trial for the treatment of Diffuse Large B Cell Lymphoma.

• ADI-001: Adicet Bio

ADI-001 is an investigational allogeneic gamma delta CAR T cell therapy being developed as a potential treatment for relapsed or refractory B-cell NHL. ADI-001 targets malignant B-cells via an anti-CD20 CAR and via the gamma delta innate and T cell endogenous cytotoxicity receptors. Gamma delta T cells engineered with an anti-CD20 CAR have demonstrated potent anti-tumor activity in preclinical models, leading to long-term control of tumor growth. In April 2022, ADI-001 was granted Fast Track Designation by the FDA for the potential treatment of relapsed or refractory B-cell NHL. Currently, the drug is in Phase I stage of its clinical trial for the treatment of Diffuse Large B Cell Lymphoma.

Diffuse Large B-Cell Lymphoma: Therapeutic Assessment

This segment of the report provides insights about the different Diffuse Large B-Cell Lymphoma drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Diffuse Large B-Cell Lymphoma

• There are approx. 70+ key companies which are developing the therapies for Diffuse Large B-Cell Lymphoma. The companies which have their Diffuse Large B-Cell Lymphoma drug candidates in the most advanced stage, i.e. Phase III include, Pfizer.

Phases

This report covers around 75+ 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

Diffuse Large B-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.

Diffuse Large B-Cell Lymphoma: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Diffuse Large B-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 Diffuse Large B-Cell Lymphoma drugs.

Diffuse Large B-Cell Lymphoma Report Insights

• Diffuse Large B-Cell Lymphoma Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Diffuse Large B-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 Diffuse Large B-Cell Lymphoma drugs?
• How many Diffuse Large B-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 Diffuse Large B-Cell Lymphoma?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Diffuse Large B-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 Diffuse Large B-Cell Lymphoma and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Miltenyi Biomedicine
• Adicet Bio
• VelosBio
• Novartis Pharmaceuticals
• Sanofi
• Eisai Co
• Schrodinger
• Sana Biotechnology
• Ranok Therapeutics
• Monte Rosa Therapeutic
• Otsuka Pharmaceutical
• OncoNano Medicine
• Regeneron Pharmaceuticals
• Hoffmann-La Roche
• Celgene
• Nurix Therapeutics
• NovalGen
• Nektar Therapeutics
• Genentech
• CSPC ZhongQi Pharmaceutical Technology

Key Products

• MB-CART2019.1
• ADI-001
• Zilovertamab vedotin
• VAY736
• THOR-707
• Tazemetostat
• SGR-1505
• SC291
• RNK05047
• MRT-2359
• OPB-111077
• ONM-501
• Odronextamab
• Obinutuzumab
• CC-122
• NX-5948
• NVG-111
• NKTR-255
• Mosunetuzumab
• Mitoxantrone Hydrochloride Liposome

This product will be delivered within 3-5 business days.