Marginal Zone Lymphoma Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

Marginal Zone Lymphoma Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight’s, “Marginal Zone Lymphoma Pipeline Insight” report provides comprehensive insights about 50+ companies and 50+ pipeline drugs in Marginal Zone Lymphoma pipeline landscape. It covers the Marginal Zone Lymphoma pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Marginal Zone Lymphoma therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Stay ahead with the latest insights! Download DelveInsight’s comprehensive Marginal Zone Lymphoma Pipeline Report to explore emerging therapies, key Marginal Zone Lymphoma Companies, and future Marginal Zone Lymphoma treatment landscapes @ Marginal Zone Lymphoma Pipeline Outlook Report

Key Takeaways from the Marginal Zone Lymphoma Pipeline Report

  • In February 2025:- BeiGene:- The purpose of the study is to compare the efficacy of zanubrutinib plus obinutuzumab versus lenalidomide plus rituximab (R^2) in participants with relapsed/refractory (R/R) follicular lymphoma (FL), as measured by progression-free survival as determined by an independent review committee in accordance with the 2014 modification of the International Working Group on non-Hodgkin lymphoma (NHL) Criteria based on n positron emission tomography and computed tomography (PET/CT), and to compare the efficacy of zanubrutinib plus rituximab versus R^2 in participants with R/R marginal zone lymphoma (MZL), as measured by progression free survival (PFS) assessed by IRC in accordance with CT-based Lugano 2014 Criteria.
  • In February 2025:- Regeneron Pharmaceuticals:- This study is researching an experimental drug called odronextamab (referred to as study drug), in combination with lenalidomide. The study is focused on participants who have one of two types of cancer: follicular lymphoma (FL) or marginal zone lymphoma (MZL) that has come back after treatment (called “relapsed”), or did not respond to treatment (called “refractory”). FL and MZL are subtypes of Non-Hodgkin ‘s lymphoma (NHL).
  • In February 2025:- Oncternal Therapeutics Inc.:- This is Phase 1b/2 study to investigate the safety and effectiveness of the investigational drug, cirmtuzumab, when given in combination with ibrutinib in patients with B-cell lymphoid malignancies. Cirmtuzumab is a monoclonal antibody that attaches to a protein (called ROR 1) that is found on hematologic tumor cells. ROR1 has been shown to play a role in cell signaling that cause leukemia and lymphoma cells to grow and survive. ROR1 is rarely found on healthy cells.
  • In February 2025:- Genmab:- The purpose of the dose-escalation part of the trial is to determine the maximum tolerated dose (MTD) and the recommended Phase-2 dose (RP2D), as well as to establish the safety profile of epcoritamab in Japanese patients with relapsed, progressive or refractory B-cell lymphoma and Japanese patients with B-cell lymphomas that have achieved partial response (PR) or complete response (CR).
  • In February 2025:- Janssen Research & Development LLC:- The purpose of this study is to evaluate the efficacy and safety of PCI-32765 (ibrutinib) administered in combination with either bendamustine and rituximab (BR) or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in adult participants with previously treated indolent Non-Hodgkin lymphoma.
  • DelveInsight’s Marginal Zone Lymphoma pipeline report depicts a robust space with 50+ active players working to develop 50+ pipeline therapies for Marginal Zone Lymphoma treatment.
  • The leading Marginal Zone Lymphoma Companies such as Incyte Corporation, HUTCHMED, InnoCare Pharma, ENTEROME SA, Beijing Mabworks Biotech Co., Ltd., ADC Therapeutics, MEI Pharma, Inc., Genentech, Inc., 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. and others.
  • Promising Marginal Zone Lymphoma Therapies such as Pirtobrutinib, Obinutuzumab, Loncastuximab tesirine 150 µg/Kg, Copanlisib, Rituximab, Venetoclax, and others.

Discover how the Marginal Zone Lymphoma treatment paradigm is evolving. Access DelveInsight’s in-depth Marginal Zone Lymphoma Pipeline Analysis for a closer look at promising breakthroughs @ Marginal Zone Lymphoma Clinical Trials and Studies

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 Zone Lymphoma.

  • Amdizalisib (HMPL-689): HUTCHMED

The investigational drug candidate amdizalisib is a novel, selective small molecule inhibitor targeting the isoform phosphoinositide 3’-kinase delta (PI3Kδ), a key component in the B-cell receptor signaling pathway. We have designed amdizalisib with increased PI3Kδ 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: InnoCare 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 cause NHL.

The Marginal Zone Lymphoma pipeline report provides insights into

  • The report provides detailed insights about companies that are developing therapies for the treatment of Marginal Zone Lymphoma with aggregate therapies developed by each company for the same.
  • It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Marginal Zone Lymphoma Treatment.
  • Marginal Zone Lymphoma Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
  • Marginal Zone Lymphoma Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
  • Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Marginal Zone Lymphoma market.

Get a detailed analysis of the latest innovations in the Marginal Zone Lymphoma pipeline. Explore DelveInsight’s expert-driven report today! @ Marginal Zone Lymphoma Unmet Needs

Marginal Zone Lymphoma Companies

Incyte Corporation, HUTCHMED, InnoCare Pharma, ENTEROME SA, Beijing Mabworks Biotech Co., Ltd., ADC Therapeutics, MEI Pharma, Inc., Genentech, Inc., 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. and others.

Marginal Zone Lymphoma pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration.

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

Marginal Zone Lymphoma 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

Download DelveInsight’s latest report to gain strategic insights into upcoming Marginal Zone Lymphoma Therapies and key Marginal Zone Lymphoma Developments @ Marginal Zone Lymphoma Market Drivers and Barriers, and Future Perspectives

Scope of the Marginal Zone Lymphoma Pipeline Report

  • Coverage- Global
  • Marginal Zone Lymphoma Companies-Incyte Corporation, HUTCHMED, InnoCare Pharma, ENTEROME SA, Beijing Mabworks Biotech Co., Ltd., ADC Therapeutics, MEI Pharma, Inc., Genentech, Inc., 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. and others.
  • Marginal Zone Lymphoma Therapies- Pirtobrutinib, Obinutuzumab, Loncastuximab tesirine 150 µg/Kg, Copanlisib, Rituximab, Venetoclax, and others.
  • Marginal Zone Lymphoma Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
  • Marginal Zone Lymphoma Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Which companies are leading the race in Marginal Zone Lymphoma drug development? Find out in DelveInsight’s exclusive Marginal Zone Lymphoma Pipeline Report—access it now! @ Marginal Zone Lymphoma Emerging Drugs and Major Companies

Table of Content

  1. Introduction
  2. Executive Summary
  3. Marginal Zone Lymphoma: Overview
  4. Pipeline Therapeutics
  5. Therapeutic Assessment
  6. Marginal Zone Lymphoma – DelveInsight’s Analytical Perspective
  7. Late Stage Products (Phase III)
  8. Tafasitamab: Incyte Corporation
  9. Drug profiles in the detailed report…..
  10. Mid Stage Products (Phase II)
  11. Orelabrutinib: InnoCare Pharma
  12. Drug profiles in the detailed report…..
  13. Early Stage Products (Phase I/II)
  14. EO2463: Enterome
  15. Drug profiles in the detailed report…..
  16. Preclinical and Discovery Stage Products
  17. Drug name: Company name
  18. Drug profiles in the detailed report…..
  19. Inactive Products
  20. Marginal Zone Lymphoma Key Companies
  21. Marginal Zone Lymphoma Key Products
  22. Marginal Zone Lymphoma- Unmet Needs
  23. Marginal Zone Lymphoma- Market Drivers and Barriers
  24. Marginal Zone Lymphoma- Future Perspectives and Conclusion
  25. Marginal Zone Lymphoma Analyst Views
  26. Marginal Zone Lymphoma Key Companies
  27. Appendix

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