DelveInsight’s, “Marginal Zone Lymphoma Pipeline Insight, 2022,” report provides comprehensive insights about 50+ companies and 50+ pipeline drugs in the 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.
Key takeaways from Marginal Zone Lymphoma Pipeline Insight Report
- DelveInsight’s marginal zone lymphoma pipeline report depicts a robust space with 40+ active players working to develop 50+ pipeline therapies for marginal zone lymphoma treatment.
- Key marginal zone lymphoma companies such as Incyte Corporation, InnoCare Pharma, 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, VelosBio Inc., Newave Pharmaceutical Inc, Boryung Pharmaceutical Co., Ltd, Cellectar Biosciences, Inc., Bio-Path Holdings, Inc., Nurix Therapeutics, Inc., Gamida Cell, BeiGene, Loxo Oncology, and others are evaluating novel marginal zone lymphoma drugs candidate to improve the treatment landscape.
- Promising marginal zone lymphoma pipeline therapies in various stages of development include Tafasitamab, 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, GDA-201, BGB-16673, LOXO-305, and others.
- 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.
- In August 2022, Gamida Cell announced dosing of the first patient in a company-sponsored Phase I/II study evaluating a cryopreserved, readily available formulation of GDA-201 for the treatment of follicular, diffuse large B cell lymphomas and marginal zone lymphoma or mantle cell lymphoma.
- In August 2022, Orelabrutinib’s supplemental New Drug Application (sNDA) was accepted by the China National Medical Products Administration (NMPA) for the treatment of patients with relapsed or refractory Marginal Zone Lymphoma (R/R MZL).
- In June 2022, ADC Therapeutics announced the first patient has been dosed in LOTIS-7, a Phase 1b clinical trial evaluating ZYNLONTA in combination with other anti-cancer agents in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. The first arm of the LOTIS-7 open-label, multi-center, multi-arm Phase Ib trial will evaluate the safety and activity of ZYNLONTA in combination with polatuzumab vedotin in patients with relapsed or refractory B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, high grade B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, and Burkitt lymphoma.
- In May 2022, Oncternal Therapeutics announced that the CIRLL clinical trial (CIRM-0001) is a Phase I/II trial evaluating zilovertamab in combination with ibrutinib in separate groups of patients with CLL or MCL. Enrollment of the dose-finding cohorts in CLL and MCL, dose-expansion cohort in CLL and MCL and randomized Phase II cohort in CLL has been completed. An additional dose-expansion cohort of up to 10 patients with marginal zone lymphoma (MZL) has recently been added. Enrollment is expected to begin in Q2 2022.
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Marginal Zone Lymphoma Overview
Marginal zone lymphoma (MZL) is the second most common indolent non-Hodgkin’s lymphoma (iNHL). 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 iNHLs, 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 to Hodgkin lymphoma.
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 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.
Marginal Zone Lymphoma Pipeline Therapeutic Assessment
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.
DelveInsight’s Marginal Zone Lymphoma Pipeline 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
Learn more about the emerging Marginal Zone Lymphoma pipeline therapies @ Marginal Zone Lymphoma Clinical Trials
Scope of the Marginal Zone Lymphoma Pipeline Report
- Coverage- Global
- Marginal Zone Lymphoma Pipeline Assessment by Product Type
- Marginal Zone Lymphoma Pipeline Assessment by Stage and Product Type
- Marginal Zone Lymphoma Pipeline Assessment by Route of Administration
- Marginal Zone Lymphoma Pipeline Assessment by Stage and Route of Administration
- Marginal Zone Lymphoma Pipeline Assessment by Molecule Type
- Marginal Zone Lymphoma Pipeline Assessment by Stage and Molecule Type
- Marginal Zone Lymphoma Companies- Incyte Corporation, InnoCare Pharma, 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, VelosBio Inc., Newave Pharmaceutical Inc, Boryung Pharmaceutical Co., Ltd, Cellectar Biosciences, Inc., Bio-Path Holdings, Inc., Nurix Therapeutics, Inc., Gamida Cell, BeiGene, Loxo Oncology, and others
- Marginal Zone Lymphoma Therapies- Tafasitamab, 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, GDA-201, BGB-16673, LOXO-305, and others.
Table of Content
- Executive Summary
- Marginal Zone Lymphoma: Overview
- Pipeline Therapeutics
- Therapeutic Assessment
- Marginal Zone Lymphoma – DelveInsight’s Analytical Perspective
- Late Stage Products (Phase III)
- Tafasitamab: Incyte Corporation
- Mid Stage Products (Phase II)
- Orelabrutinib: InnoCare Pharma
- Early Stage Products (Phase I/II)
- EO2463: Enterome
- Preclinical and Discovery Stage Products
- Drug name: Company name
- Inactive Products
- Marginal Zone Lymphoma Key Companies
- Marginal Zone Lymphoma Key Products
- Marginal Zone Lymphoma- Unmet Needs
- Marginal Zone Lymphoma- Market Drivers and Barriers
- Marginal Zone Lymphoma- Future Perspectives and Conclusion
- Marginal Zone Lymphoma Analyst Views
- Marginal Zone Lymphoma Key Companies
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?
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