Follicular Lymphoma - Pipeline Insight, 2024

This “Follicular Lymphoma- Pipeline Insight, 2024” report provides comprehensive insights about 50+ companies and 50+ pipeline drugs in Follicular 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

Follicular Lymphoma: Understanding

Follicular Lymphoma: Overview

Follicular lymphoma is a form of cancer. It is a type of non-Hodgkin lymphoma (NHL), which is a group of related cancers that affect the lymphatic system (lymphomas). The lymphatic system functions as part of the immune system and helps to protect the body against infection and disease. It consists of a network of tubular channels (lymph vessels) that drain a thin watery fluid known as lymph from different areas of the body into the bloodstream.

Follicular lymphoma is a B-cell lymphoma. It is characterized by the transformation of a B-cell into a malignant (cancerous) cell. Abnormal, uncontrolled growth and multiplication (proliferation) of malignant B-cells can lead to enlargement of specific lymph node regions; involvement of other lymphatic tissues such as the spleen or bone marrow; and spread to other bodily tissues and organs. The term follicular lymphoma comes from the observation that the cancer cells are group in clusters (or follicles) within the lymph nodes.

Non-Hodgkin lymphoma including follicular lymphoma can be characterized as “low-grade” (or indolent), meaning the cancer tends to grow slowly and results in few associated symptoms or “high-grade” (aggressive), meaning the cancer typically grows rapidly. FL is the second common form of NHL in the U.S with an estimated incidence of six new cases/ 100 000 persons/year. FL is most common in the USA and Europe, but less so to the rest of the world. FL is a disease of older adults (median age 55 years) and relatively uncommon in children; rare under age 20 years. Exposure to pesticides and herbicides have been established as risk factors.

Causes
FL originates from germinal/follicular center B cells. Most cases of FL show at (14;18) (q32;q21), which leads to an overexpression of BCL2, an anti-apoptotic protein. About 5% of FL have BCL-6 deregulating mutations. BCL-6 is required for germinal center formation. BCL-6 related protein is a repressor of transcription and modulates the interleukin-4 response of B-cells. Other upregulated genes thought to play a role in follicular lymphoma are associated with p21, p16, and G1 arrest. Similarly, regulatory proteins (p120, p16, CKD10, p21), transcription factors (Id-2 and PAX5), and cell-cell interaction (TNF, IL4RA, and IL2RG) related genes are also upregulated. Adhesion related genes MRP14 and MRP8 are downregulated.

Diagnosis
Evaluation of FL should include history, physical examination, laboratory studies (complete blood count with differential, routine chemistries, and lactate dehydrogenase) and imaging (including CT, MRI and whole-body combined fluorodeoxyglucose positron emission tomography with computed tomography (FDG PET/CT)). Diagnosis of FL will usually require a lymph node morphological assessment and flow cytometry. Sometimes genetic testing is incorporated to confirm the diagnosis.

Treatment and Management
The management of FL depends on the disease stage. Options available for the treatment of follicular lymphoma include radiation (RT), immunochemotherapy (Rituximab plus chemotherapy), Bundamustine with immunotherapy, R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone), immunochemotherapy plus RT, CVP (cyclophosphamide, vincristine, and prednisolone), single-agent rituximab, and observation until progression. The choice of regimen depends on the stage of the disease, preference of physician, and preference of the patient.

In stage 1 lymphomas, radiation therapy is preferred in grades 1, 2, and 3a lymphomas. In contrast, patients with grade 3b FL are treated with aggressive regimens (such as R-CHOP) used for other aggressive lymphomas (e.g., diffuse large B cell lymphoma).

Treatment of stage II-IV FL is mainly focused on the improvement of life, alleviation of symptoms, and reversal of cytopenias. Asymptomatic patients are mostly observed closely without any intervention. Anti-CD20 antibodies (obinutuzumab, rituximab) are combined with chemotherapy regimens for the treatment of symptomatic advanced follicular lymphomas.

Autologous hematopoietic stem cell transplantation is the preferred management for recurrent/relapsed patients or patients who have undergone a transformation to higher grade lymphoma. Patients with advanced, relapsed, or refractory disease are encouraged to take part in clinical trials of new therapies like CAR-T cell therapy (chimeric antigen receptor T cells).

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

Follicular Lymphoma Emerging Drugs Chapters

This segment of the Follicular 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.

Follicular Lymphoma Emerging Drugs

Tafasitamab: Incyte Corporation
Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb® engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). The drug currently investigated in Phase III trials for the condition.

Epcoritamab: Genmab A/S
Epcoritamab (Duo Body®-CD3x CD20) is a proprietary bispecific antibody created using Genmab’s DuoBody® technology, jointly owned by Genmab and AbbVie Inc. It targets CD20 on the B-cells, a clinically well-validated target that is expressed in a wide variety of B-cell malignancies. Epcoritamab (DuoBody®-CD3xCD20) is currently under investigation in multiple ongoing clinical studies including a Phase III study for relapsed/refractory diffuse large B-cell lymphoma (DLBCL) andfollicularLymphoma.

Zanubrutinib - BeiGene
Zanubrutinib (BGB-3111) - a small molecule inhibitor of Bruton’s tyrosine kinase, or BTK, that is currently being evaluated in a broad late-stage clinical trials program globally, including in China, as a potential monotherapy and in combination with other therapies to treat various B cell malignancies. BTK is a key component of the B-cell receptor, or BCR, signaling pathway and is an important regulator of cell proliferation and cell survival in various B cell malignancies. BTK inhibitors block BCR-induced BTK activation and its downstream signaling, leading to growth inhibition and cell death in certain malignant white blood cells called B-cells. Zanubrutinib is an orally active inhibitor that covalently binds to BTK, resulting in irreversible inactivation of the enzyme. The drug is currently under Phase III trial of the disease.

Pembrolizumab: Merck & Co.

Pembrolizumab is a monoclnal antibody that binds to and blocks PD-1 located on lymphocytes. This receptor is generally responsible for preventing the immune system from attacking the body's own tissues; it is a so-called immune checkpoint. Normally, the PD-1 receptor on activated T-cells binds to ligands PD-L1 or PD-L2 on other cells, deactivating a potential T-cell-mediated immune response against normal cells in the body. Currently, it is in Phase II stage of development to treat Follicular lymphoma.

Follicular Lymphoma: Therapeutic Assessment

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

Major Players in Follicular Lymphoma

There are approx. 50+ key companies which are developing the therapies for Follicular Lymphoma. The companies which have their Follicular Lymphoma drug candidates in the most advanced stage, i.e. phase III.

Phases

This report covers around 50+ 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

Follicular 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

• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Ophthalmic
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal

Molecule Type

Products have been categorized under various Molecule types such as

• Oligonucleotide
• Peptide
• Small molecule

Product Type

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

Follicular Lymphoma: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Follicular 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 Follicular Lymphoma drugs.

Follicular Lymphoma Report Insights

• Follicular Lymphoma Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Incyte Corporation
• Genmab A/S
• BeiGene
• Merck & Co.
• ADC Therapeutics
• Xynomic Pharmaceuticals
• Nordic Nanovector
• TG Therapeutics Inc
• Allogene Therapeutics
• MEI Pharma
• Innovent Biologics

Key Products

• Tafasitamab
• Epcoritamab
• Zanubrutinib
• Pembrolizumab
• Loncastuximab tesirine
• Abexinostat
• Betalutin
• TG-1801
• ALLO-501
• Zandelisib
• IBI376

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