Marginal Zone Lymphoma - Pipeline Insight, 2024

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

Marginal Zone Lymphoma Understanding

Marginal Zone Lymphoma: Overview

Marginal zone lymphoma (MZL) is the second most common indolent non-Hodgkin’s lymphoma (i NHL). There are three types of marginal zone lymphomas: the extranodal MZL (EMZL) of mucosa-associated lymphoid tissue (MALT or gastric GALT), the splenic MZL, and the nodal MZL. EMZL can originate at virtually any extranodal site and arises in organs that normally lack lymphoid tissue (eg, stomach, intestine, thyroid, lung, and skin). The most frequently affected organ in EMZL is the stomach, and there is compelling evidence for a causal relationship between H. pylori and gastric EMZL. SMZL arises predominantly from the marginal zone memory B-cells located in the follicles of the spleen, splenic hilar lymph nodes, BM, and the peripheral blood. The pathogenesis of SMZL has yet to be fully understood; similar to other subtypes of MZL, it likely involves the persistent stimulation of BCR signaling pathway, with increasing proliferation and survival of malignant B cells. NMZL is the least common subtype of MZL. The molecular pathogenesis of NMZL is still incompletely described but likely involves constitutive BCR signaling, resulting in proliferation and survival of malignant B cells. The three MZLs share common lesions and deregulated pathways but also present specific changes that can be used for their differential diagnosis. Since their differential diagnosis is not straightforward in the non-rare cases presenting with disseminated disease involving lymph nodes, spleen, peripheral blood, bone marrow, or other extranodal sites, a better understanding of the molecular events underlying each subtype may have practical relevance. MZL is considered a slow growing indolent disease with a favorable outcome. While the majority of MZL have a relatively indolent course, like other i NHLs, it too can transform to a more aggressive lymphoma. Histologic transformation to DLBCL occurs in 7.5% of cases, with the majority (73.5%) from EMZL, followed by NMZL (14.7%). Rarely, MZL can transform toHodgkinlymphoma.

Marginal Zone Lymphoma - Pipeline Insight, 2024 report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Marginal Zone Lymphoma pipeline landscape is provided which includes the disease overview and Marginal Zone Lymphoma treatment guidelines. The assessment part of the report embraces, in depth Marginal Zone 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, Marginal Zone Lymphoma collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

• A better understanding of disease pathogenesis contributing to the development of novel therapeutics for Marginal Zone Lymphoma.
• In the coming years, the Marginal Zone Lymphoma market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.

The companies and academics that are working to assess challenges and seek opportunities that could influence Marginal Zone Lymphoma R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.

• A detailed portfolio of major pharma players who are involved in fueling the Marginal Zone Lymphoma treatment market. Several potential therapies for Marginal Zone Lymphoma are under investigation. With the expected launch of these emerging therapies, it is expected that there will be a significant impact on the Marginal Zone Lymphoma market size in the coming years.
• This in-depth analysis of the pipeline assets (in early-stage, mid-stage and late stage of development for the treatment of Marginal Zone Lymphoma) includes therapeutic assessment and comparative analysis. This will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Marginal Zone Lymphoma Emerging Drugs Chapters

This segment of the Marginal Zone 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.

Marginal Zone Lymphoma Emerging Drugs

Tafasitamab: Incyte Corporation Tafasitamab is an investigational humanized Fc-engineered monoclonal antibody directed against CD19. In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc. Tafasitamab incorporates an XmAb® engineered Fc domain, which is intended to lead to a significant potentiation of antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), thus aiming to improve a key mechanism of tumor cell killing. The therapy is currently in Phase III stage of clinical trial evaluation to treat Marginal ZoneLymphoma.

Amdizalisib (HMPL-689): HUTCHMEDThe investigational drug candidate amdizalisib is a novel, selective small molecule inhibitor targeting the isoform phosphoinositide 3’-kinase delta (PI3Kd), a key component in the B-cell receptor signaling pathway. We have designed amdizalisib with increased PI3Kd isoform selectivity. Amdizalisib’s pharmacokinetic properties have been found to be favorable with good oral absorption, moderate tissue distribution and low clearance in pre-clinical pharmacokinetic studies. Amdizalisib is being investigated in studies in the U.S., Europe, China and Australia in various subtypes of advanced relapsed or refractory non-Hodgkin's lymphoma, including follicular lymphoma and marginal zone lymphoma.

Orelabrutinib: Inno Care Pharma Orelabrutinib is a small molecule Bruton’s tyrosine kinase inhibitor (BTKi) developed for the treatment of cancer and in development for the potential treatment of autoimmune diseases. In the field of oncology, InnoCare received approval for orelabrutinib from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL)/small lymphocytic lymphoma (R/R SLL), and the treatment of patients with relapsed/refractory mantle cell lymphoma (R/R MCL). Currently, it is in Phase II stage of clinical trial evaluation to treat Marginal Zone Lymphoma(MZL).

EO2463: Enterome EO2463 is an innovative, off-the-shelf microbiome-peptide based cancer vaccine that combines four microbiome-peptides of B lymphocyte-specific lineage markers. EO2463 is designed to trigger the immune system into recognizing B cells as bacterial (i.e. non-self) and eliciting a targeted cell-killing response. The clinical rationale behind targeting these specific lineage cell markers is to induce the full depletion of malignant B lymphocytes that causeNHL.

Marginal Zone Lymphoma: Therapeutic Assessment

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

Major Players in Marginal Zone Lymphoma

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

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

Marginal Zone 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

• Inhalation
• Inhalation/Intravenous/Oral
• Intranasal
• Intravenous
• Intravenous/ Subcutaneous
• NA
• Oral
• Oral/intranasal/subcutaneous
• Parenteral
• Subcutaneous

Molecule Type

Products have been categorized under various Molecule types such as

• Antibody
• Antisense oligonucleotides
• Immunotherapy
• Monoclonal antibody
• Peptides
• Protein
• Recombinant protein
• Small molecule
• Stem Cell
• Vaccine

Product Type

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

Marginal Zone Lymphoma: Pipeline Development Activities

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

Marginal Zone Lymphoma Report Insights

• Marginal Zone Lymphoma Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Incyte Corporation
• HUTCHMED
• Inno CarePharma
• ENTEROME SA
• Beijing Mabworks Biotech Co., Ltd.
• ADC Therapeutics
• MEI Pharma, Inc.
• Genentech, Inc.
• Incyte Corporation
• Novartis
• AstraZeneca
• Kite Pharma
• Roche
• Oncternal Therapeutics, Inc
• Celgene
• IGM Biosciences, Inc.
• Loxo Oncology
• Genmab
• ArQule
• Sound Biologics
• Adicet Bio, Inc
• Celldex Therapeutics
• TG Therapeutics, Inc.
• VelosBio Inc.
• Newave Pharmaceutical Inc
• Boryung Pharmaceutical Co., Ltd
• Cellectar Biosciences, Inc.
• Bio-Path Holdings, Inc.
• Nurix Therapeutics, Inc.

Key Products

• Tafasitamab
• Amdizalisib (HMPL-689)
• Orelabrutinib
• EO2463
• MIL62
• Loncastuximab
• NX-2127
• LP-168
• Zandelisib
• BR101801
• BP1002
• Mosunetuzumab
• CLR 131
• IBI376
• Pirtobrutinib
• Zilovertamab vedotin
• TG-1801
• VAY736
• ADI-001
• CDX-1140
• PSB202
• Acalabrutinib
• axicabtagene ciloleucel
• Obinutuzumab
• Cirmtuzumab
• Nemtabrutinib
• Lenalidomide
• IGM-2323
• Epcoritamab

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