B-cell Lymphoma - Pipeline Insight, 2024

This “B-cell Lymphoma- Pipeline Insight, 2024” report provides comprehensive insights about 295+ companies and 300+ pipeline drugs in 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

B-cell Lymphoma: Understanding

B-cell Lymphoma: Overview

B-cell lymphoma is a type of non-Hodgkin lymphoma (NHL) that arises from B lymphocytes, which are a type of white blood cell responsible for producing antibodies to fight infections. B-cell lymphomas account for about 85% of all NHL cases and encompass a variety of subtypes, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma, mantle cell lymphoma, and Burkitt lymphoma. Each subtype has distinct clinical behaviors, but in general, B-cell lymphomas are characterized by abnormal proliferation of B-cells in the lymphatic system, often involving the lymph nodes, spleen, and bone marrow.

The signs and symptoms of B-cell lymphoma can vary depending on the subtype and stage of the disease but commonly include:

• Lymphadenopathy: Painless swelling of lymph nodes, especially in the neck, armpit, or groin, is the most common symptom.
• Systemic "B" symptoms: Fever, night sweats, and unintentional weight loss are hallmark signsof more aggressive types of B-cell lymphoma.
• Fatigue: Generalized fatigue and weakness are common due to anemia or the overall systemic impact of the disease.

Other symptoms: Depending on the areas affected, patients may experience abdominal pain, chest discomfort, or symptoms related to organ involvement, such as liver or spleen enlargement.B-cell lymphoma develops when genetic mutations occur in the DNA of B lymphocytes, leading to uncontrolled cell growth and the avoidance of normal apoptotic mechanisms (programmed cell death). These mutations can arise due to chromosomal translocations, deletions, or other abnormalities in genes that regulate cell division, such as BCL2, MYC, and BCL6.

In aggressive forms like DLBCL, mutations drive rapid proliferation of malignant B cells, leading to large, often bulky lymph node masses. In contrast, more indolent forms like follicular lymphoma progress slowly, allowing for prolonged survival but eventual disease transformation in some cases. The interaction between malignant B cells and their microenvironment, including surrounding immune cells and stromal cells, also plays a role in the progression of the disease.

The diagnosis of B-cell lymphoma requires a combination of clinical evaluation, imaging, and biopsy. A definitive diagnosis is made by examining lymph node tissue or other affected sites under a microscope to identify malignant B cells. Immunohistochemistry and flow cytometry are used to determine the specific subtype of B-cell lymphoma by analyzing cell surface markers (e.g., CD20, CD10, BCL2).

Advanced techniques like fluorescence in situ hybridization (FISH) and gene expression profiling help identify genetic mutations and chromosomal rearrangements characteristic of certain subtypes. Imaging studies, such as CT or PET scans, are used to assess the extent of disease involvement, including the presence of extranodal disease (spread to organs outside the lymph nodes).

The treatment of B-cell lymphoma depends on the subtype, stage, and aggressiveness of the disease. For aggressive subtypes like DLBCL, chemotherapy combined with immunotherapy (e.g., the R-CHOP regimen: rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) is the standard of care. For indolent forms like follicular lymphoma, a "watch and wait" approach may be used in early stages, with treatment initiated upon disease progression

Targeted therapies, such as Bruton’s tyrosine kinase (BTK) inhibitors and CAR T-cell therapy, have become significant advancements for relapsed or refractory cases. In addition, radiation therapy may be used in localized disease, and hematopoietic stem cell transplantation is an option for some patients with relapsed disease. The prognosis varies widely, with aggressive forms requiring immediate treatment but potentially curable, while indolent forms may be managed over many years.

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

B-cell Lymphoma Emerging Drugs Chapters

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

B-cell Lymphoma Emerging Drugs

Lisocabtagene maraleucel: Bristol Myers Squibb

Lisocabtagene maraleucelis a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells. It is made from a patient’s own T cells, which are collected and genetically reengineered to become CAR T cells that are then delivered via infusion as a one-time treatment. Breyanzi is approved by the U.S.

Food and Drug Administration (FDA) for the treatment of adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL), not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal LBCL, and follicular lymphoma grade 3B who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy, or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplant due to comorbidities or age, or relapsed or refractory disease after two or more lines of systemic therapy.

The drug is currently in Phase III stage of development for treatment of B cell lymphoma.

Glofitamab: Hoffmann-La Roche

Glofitamab is a CD20xCD3 T-cell engaging bispecific antibody designed to target CD3 on the surface of T-cells and CD20 on the surface of B-cells. The drug candidate was designed with a novel 2:1 structural format. This T-cell engaging bispecific antibody is engineered to have one region that binds to CD3, a protein on T-cells, a type of immune cell, and two regions that bind to CD20, a protein on B-cells, which can be healthy or malignant. This dual-targeting brings the T-cell in close proximity to the B-cell, activating the release of cancer cell-killing proteins from the T-cell.

Columvi is part of Roche’s broad and industry-leading CD20xCD3 T-cell-engaging bispecific antibody clinical development programme that also includes Lunsumio® (mosunetuzumab), which aims to provide tailored treatment options that suit the diverse needs, preferences, and experiences of people with blood cancers and healthcare systems. Roche is investigating Columvi as a monotherapy and in combination with other medicines for the treatment of diffuse large B-cell lymphoma (DLBCL) and other blood cancers. The drug is currently in Phase III stage of development for treatment of B cell lymphoma.

NKTR-255: Nektar Therapeutics

NKTR-255 is an investigational drug developed by Nektar Therapeutics, designed as a polymer-conjugated interleukin-15 (IL-15) receptor agonist. Its primary goal is to enhance the immune system's capacity to combat cancer by boosting the proliferation and survival of natural killer (NK) cells and memory CD8+ T cells. This mechanism involves engaging the entire IL-15 receptor complex, which may lead to the formation of long-term immunological memory and a sustained anti-tumor immune response. The drug is currently in Phase II/III stage of development for treatment of B cell lymphoma.

Zamtocabtagene autoleucel: Miltenyi Biomedicine GmbH

Zamtocabtagene autoleucel, also known as MB-CART2019.1, is an investigational chimeric antigen receptor T-cell (CAR-T) therapy developed by Miltenyi Biotec. This therapy targets both CD19 and CD20 antigens, making it a bispecific treatment option for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and other B-cell malignancies. Zamtocabtagene autoleucel is designed to enhance the immune response against B-cell tumors by utilizing genetically modified T cells that express CARs targeting both CD19 and CD20.

The therapy employs a lentiviral vector to transduce autologous T cells, which are then expanded and infused back into the patient after lymphodepleting chemotherapy. This dual targeting approach aims to overcome resistance mechanisms associated with single-target therapies, particularly in cases where the tumor may lose expression of one of the targets. The drug is currently in Phase II stage of development for treatment of B cell lymphoma.

MB-CART20.1: Miltenyi Biomedicine GmbH

MB-CART20.1 is an investigational CAR-T cell therapy engineered to target the CD20 protein, which is highly expressed on the surface of B-cells in certain cancers, including non-Hodgkin lymphoma and chronic lymphocytic leukemia. By modifying a patient's T-cells to express chimeric antigen receptors (CARs) that recognize CD20, MB-CART20.1 enables the immune system to selectively attack and eliminate cancerous B-cells.

This therapy is designed to offer a novel option for patients with relapsed or refractory CD20-positive malignancies, aiming to improve outcomes through enhanced tumor targeting and prolonged remission. Clinical trials are ongoing to assess its efficacy and safety. The drug is currently in Phase I/II stage of development for treatment of B cell lymphoma.

AVM0703: AVM Biotechnology

AVM0703 is a clinical-stage therapeutic that works by rapidly inducing the production and release of endogenous bispecific gamma delta TCR+ and invariant TCR+ Natural Killer T-like cells (AVM-NKT), which possess unique immune properties. Following a single dose of AVM0703, these supercharged immune cells appear in the bloodstream and target abnormal cells, including cancer cells, infected cells, and autoreactive lymphocytes.

AVM0703’s mechanism is based on a proprietary suprapharmacologic dose of dexamethasone, designed to deliver high doses without typical side effects. This enhanced dexamethasone formulation triggers the activation and mobilization of AVM-NKT cells, offering a potent yet gentler treatment option by targeting malignancies and immune disorders with precision. The drug is currently in Phase I/II stage of development for treatment of B cell lymphoma.

LBS-007: Lin BioScience, Inc

LBS-007 is a novel targeted therapy for the treatment of a broad array of cancers. It has demonstrated activity against leukemia and solid tumors, especially in chemotherapy-resistant cell lines and other cancer cell lines. LBS-007 has obtained Orphan Drug Destination (ODD) for Acute Lymphoma Leukemia (ALL) from US FDA in 2018/March and entered a first-in-human Phase I/II trial. LBS-007 inhibits cancer cell replication by interrupting the S phase of the cell cycle.

Its mechanism of action is to inhibit a key regulator protein of the cell cycle, CDC7. Inhibition of CDC7 stops the proliferation of tumor cells and results in cancer cell death. Because CDC7’s activity is often upregulated in cancer cells in comparison to healthy cells, it’s an ideal candidate for a targeted anti-cancer therapy. The drug is currently in Preclinical stage of development for treatment of B cell lymphoma.

B-cell Lymphoma: Therapeutic Assessment

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

Major Players in B-cell Lymphoma

There are approx. 295+ key companies which are developing the therapies for B-cell Lymphoma. The companies which have their B-cell Lymphoma drug candidates in the most advanced stage, i.e. Phase III include, Denovo BioPharma.

Phases

The report covers around 300+ 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

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

• 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.

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 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 B-cell Lymphoma drugs.

B-cell Lymphoma Report Insights

• B-cell Lymphoma Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Lisocabtagene maraleucel
• Hoffmann-La Roche
• Nektar Therapeutics
• Miltenyi Biomedicine GmbH
• AVM Biotechnology
• Lin BioScience, Inc
• Incyte Corporation
• ADC Therapeutics S.A.
• Genor Biopharma
• Beijing InnoCare Pharma Tech Co., Ltd.
• CARGO Therapeutics
• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• SystImmune
• LIBO PHARMA
• Abclon
• BeiGene
• Cellectis
• Iovance Biotherapeutics, Inc.
• Guangzhou Excelmab
• Y-mAbs Therapeutics
• TG Therapeutics
• Sutro Biopharma
• AbbVie
• Aleta Biotherapeutics
• Janssen Research & Development, LLC
• Lantern Pharma
• Beijing Immunochina Medical Science and Technology
• Bantam Pharmaceutical
• Lin Bioscience
• SFA Therapeutics
• neoX Biotech
• March Biosciences
• HUTCHMED

Key Products

• Bristol Myers Squibb
• Glofitamab
• NKTR-255
• Zamtocabtagene autoleucel
• MB-CART20.1
• AVM0703
• LBS-007
• Parsaclisib
• Loncastuximab tesirine
• GB-241
• ICP-248
• CRG-022
• TQB3702
• GNC-038
• NM-IL-12
• AT101
• BGB-16673
• UCART20x22
• IOV-2001
• EX103
• CD38-SADA
• TG-1801
• STRO-001
• ABBV-319
• ALETA-001
• JNJ-80948543
• LP-284
• INS19 CAR-T Cells
• BTM 3566
• LBS-007
• SFA-001
• NXD07
• MB-105
• HMPL A067