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Dec 22, 2023

Monoclonal Antibodies Clinical Trial Experiences Momentum: DelveInsight Estimates a Diverse Pipeline Comprising 180+ Companies Working in the Domain

The monoclonal antibodies pipeline and clinical trial analysis report deliver

The monoclonal antibodies pipeline and clinical trial analysis report deliver important insights on ongoing research, clinical strategies, upcoming therapeutics, and commercial analysis.

LAS VEGAS, June 5, 2023 /PRNewswire/ -- DelveInsight's 'Monoclonal Antibodies Competitive Landscape – 2023' report provides comprehensive global coverage of available, marketed, and pipeline monoclonal antibodies in various stages of clinical development, major pharmaceutical companies working to advance the pipeline space, company assessment, comparative assessment, and future growth potential of the monoclonal antibodies competitive domain.

Key Takeaways from the Monoclonal Antibodies Competitive Landscape Report

Over 180+ monoclonal antibody companies are evaluating 230+ monoclonal antibody drugs in various stages of development, and their anticipated acceptance in the monoclonal antibodies market would significantly increase market revenue.

Key monoclonal antibody companies such as Novartis, Gmax Biopharm, Omeros Corporation, Merck Sharp & Dohme, Disc Medicine, Eledon Pharmaceuticals, Alexion AstraZeneca Rare Disease, Chinook Therapeutics, Omeros Corporation, Novo Nordisk, Merck KGaA, Bristol-Myers Squibb, Jacobio Pharmaceuticals, Nectin Therapeutics Ltd, Y-mAbs Therapeutics, OncoResponse, Inc., Fate Therapeutics, Pelican Therapeutics, Inc., Heat Biologics, Oncternal Therapeutics, Phanes Therapeutics, Pharmacyclics LLC, Immunitas Therapeutics, Hummingbird Bioscience, Inc., Sanofi, Takeda, Agenus Inc., Aulos Bioscience, Inc., ChemomAb Ltd, Celldex Therapeutics, Celgene, Janssen Research & Development, LLC, Adaptive Biotechnologies, BeiGene, Vaccinex Inc., Jasper Therapeutics, Inc., Shanghai Junshi Bioscience Co., Ltd., TopAlliance Biosciences, Inc., and others are evaluating new monoclonal antibody drugs to improve the treatment landscape.

Promising monoclonal antibodies pipeline drugs such as Ianalumab, GMA-131, anti-MASP-2 monoclonal antibody, MK-2060, DISC-0974, AT-1501, Ravulizumab, BION 1301, Narsoplimab, Pembrolizumab, Ziltivekimab, Opdivo, Avelumab, JAB-BX102, and others are under different phases of monoclonal antibodies clinical trials.

In March 2023, Shanghai - Jacos Pharmaceuticals announced a clinical collaboration with Merck to evaluate the combination therapy of Si's CD73 monoclonal antibody JAB-BX102 and Merck's PD-1 inhibitor KEYTRUDA (pembrolizumab). This clinical study will evaluate the clinical effect of JAB-BX102 in combination with KEYTRUDA in advanced solid tumors. Under the terms of the agreement, Merck will provide KEYTRUDA.

In March 2023, Simcere Pharmaceutical Group Limited announced that Simcere Zaiming, an innovative oncology pharmaceutical company of Simcere has entered into a clinical collaboration agreement with MSD to evaluate the combination of SIM0235, a potential first-in-class humanized anti-tumor necrosis factor receptor 2 (TNFR2) monoclonal antibody, and MSD's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with advanced solid tumors and cutaneous T-cell lymphoma (CTCL).

In March 2023, BioNTech SE and OncoC4 announced that they had entered into an exclusive worldwide license and collaboration agreement to develop and commercialize OncoC4's next-generation anti-CTLA-4 monoclonal antibody candidate, ONC-392, as monotherapy or combination therapy in various cancer indications. The transaction is expected to close in the first half of 2023, subject to customary closing conditions and regulatory clearances.

In February 2023, Vir Biotechnology announced that the research collaboration agreement established with GSK in 2020 had been amended to reflect that Vir will continue its ongoing efforts to discover, develop and advance next-generation solutions for COVID-19 and other potential coronavirus outbreaks, independently or with other partners. Together, the Companies will continue working to ensure ongoing access to sotrovimab for patients around the world, where authorized, and to develop new therapies for influenza and other respiratory diseases.

In January 2023, CARsgen Therapeutics Holdings Limited announced CARsgen's execution of a collaboration agreement with F. Hoffmann-La Roche Ltd to evaluate CARsgen's investigational drug AB011, which received IND clearance globally, in combination with atezolizumab, Roche's PD-L1 checkpoint inhibitor, along with standard-of-care chemotherapy in patients with gastric or gastroesophageal junction carcinoma. Under the terms of the agreement, Roche will be responsible for the operation and conduct of the trial while both companies co-share the costs of the AB011 treatment arms in the study. As part of the clinical collaboration, CARsgen's proprietary CLDN18.2 IHC test kit, which has shown excellent specificity and sensitivity profiles, will be applied to evaluate CLDN18.2 expression in gastric cancer patients.

In November 2022, Exelixis and Sairopa announced that the companies had entered into an exclusive clinical development and option agreement for ADU-1805, a potentially best-in-class monoclonal antibody that targets SIRPa. SIRPa expressed on myeloid cells interacts with CD47 on the surface of cancer cells, blocks the ability of macrophages to clear tumor cells via phagocytosis, and inhibits tumor antigen presentation to T-cells. Blocking SIRPa has the potential to improve the immune system's ability to attack tumors by addressing a significant immune-suppressive component of the tumor microenvironment.

In October 2022, Compass Therapeutics announced a clinical trial collaboration and supply agreement with Merck (known as MSD outside the United States and Canada). The collaboration enables the evaluation of the safety and efficacy of Compass' CTX-471, a fully human monoclonal antibody that binds and activates a novel epitope of the co-stimulatory receptor CD137 (expressed on T cells and NK cells) in combination with Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in Phase Ib trial. Under the agreement, Compass is the study sponsor, and Merck will provide the clinical supply of KEYTRUDA; the companies will form a Joint Development Committee to review the clinical trial results.

In September 2022, Abpro announced a strategic partnership with Celltrion for its cancer molecule ABP 102, an antibody therapy for patients suffering from HER2+ cancer, including breast, gastric, and pancreatic cancer. Through this global partnership, Abpro will receive payments from Celltrion of up to $1.75 Billion, including an equity investment, development and commercial milestone payments, and worldwide profit sharing. Celltrion will be in charge of developing ABP 102 following the completion of in vitro studies by Abpro and will have worldwide commercialization rights. HER2+ type cancer is implicated in up to 30% of all cases of breast, gastric, pancreatic, and other forms of cancer.

Request a sample and discover the recent advances in monoclonal antibodies treatment @ Monoclonal Antibodies Competitive Landscape Report

Monoclonal Antibodies Overview

Monoclonal antibody (mAb) allows for a far more accurate understanding of the humoral immune response by dissecting it into specific B-lymphocyte populations. A wide variety of mAbs have been developed to target antigens found in the kidney, bladder, and prostate. The importance of therapeutic monoclonal antibodies is growing year by year. Their very specific antigen targeting can give very effective medical treatment, and the advent of molecular-targeted medicine is enabling the development of a new generation of therapeutic medicines. However, there is one major hurdle to overcome. Although all proteins have original native intact structures for their own distinct functions, the majority of developed therapeutic monoclonal antibodies exhibit selectivity for the primary structures of target antigens. Stereo-specific monoclonal antibodies that recognize target antigen conformational features may thus provide a far more diverse approach. Their use may alter the fundamental assumptions underlying the use of therapeutic antibodies.

Find out more about monoclonal antibodies drugs @ Monoclonal Antibodies Treatment

Monoclonal Antibodies Pipeline Analysis: Drug Profile

Ianalumab: Novartis

Ianalumab (VAY736) is a novel, defucosylated human IgG1 monoclonal antibody that targets the TNF family's human B cell-activating factor (BAFF). The BAFF receptor is mostly expressed in B cells and plays an important role in B cell maturation, activation, and survival. VAY736 binds to the BAFF receptor and inhibits BAFF binding to the BAFF-R, preventing BAFF-R-mediated signaling in B cells. It is also designed to eradicate B cells from circulation in vivo by antibody-dependent cellular cytotoxicity (ADCC). By removing fucose residues from the carbohydrate moiety connected to the Fc component of the antibody, ianalumab's ADCC activity is considerably increased. It is now being studied in Phase III clinical trials for the treatment of Sjögren's syndrome, Lupus nephritis, Immune thrombocytopenia, Systemic Lupus Erythematosus, and warm autoimmune hemolytic anemia. In addition, the molecule is being evaluated in Phase II development for Idiopathic pulmonary fibrosis, Multiple Sclerosis, and other diseases.

Ziltivekimab: Novo Nordisk

Ziltivekimab is a proprietary anti-interleukin-6 ligand monoclonal antibody (anti-IL6 mAb) that targets residual inflammatory cardiovascular risk in patients with severe chronic kidney disease (CKD). Ziltivekimab is being developed as a medication to minimize the incidence of significant cardiovascular adverse events in chronic kidney disease (CKD) patients with atherosclerotic cardiovascular disease (ASCVD) and inflammation. Patients with moderate to severe CKD, ASCVD, and inflammation are at high risk of an adverse cardiovascular event, and there are no licensed medications to reduce this risk. Interleukin-6 (IL-6) has been established to be an independent, causative component of ASCVD in human genetic research and preclinical studies. The drug is currently in Phase III testing for the treatment of patients with moderate to severe chronic renal disease.

A snapshot of the Monoclonal Antibodies Pipeline Drugs mentioned in the report:

Monoclonal Antibodies Drugs

Company

Phase

Indication

Narsoplimab

Omeros Corporation

Preregistration

Thrombotic microangiopathies

Pembrolizumab

Merck & Co

Preregistration

Adenocarcinoma

Ianalumab

Novartis

Phase III

Autoimmune hemolytic anemia; Idiopathic thrombocytopenic purpura; Lupus nephritis; Sjogren's syndrome; Systemic lupus erythematosus

Avelumab

Merck KGaA

Phase III

Colorectal cancer; Diffuse large B cell lymphoma; Gastric cancer; Head and neck cancer; Oesophageal cancer; Ovarian cancer; Solid tumors; Triple-negative breast cancer

Ziltivekimab

Novo Nordisk

Phase III

Cardiovascular disorders; Inflammation; Kidney disorders

Nivolumab

Bristol-Myers Squibb/Ono Pharmaceuticals

Phase III

Bladder cancer; Breast cancer; Fallopian tube cancer; Glioblastoma; Multiple myeloma; Ovarian cancer; Peritoneal cancer; Prostate cancer

Iscalimab

Novartis

Phase II

Graves' disease; Hidradenitis suppurativa; Liver transplant rejection; Lupus nephritis; Myasthenia gravis; Sjogren's syndrome; Systemic lupus erythematosus; Type 1 diabetes mellitus

BION-1301

Chinook Therapeutics

Phase II

IgA nephropathy

Tegoprubart

Eledon Pharmaceuticals

Phase II

Amyotrophic lateral sclerosis

DISC-0974

Disc Medicine

Phase I/II

Anemia

JAB-BX102

Jacobio Pharmaceuticals

Phase I/II

Solid tumors

Learn more about the emerging monoclonal antibodies pipeline drugs @ Monoclonal Antibodies Clinical Trials

Scope of the Monoclonal Antibodies Competitive Landscape Report

Coverage: Global

Key Monoclonal Antibodies Companies: Novartis, Gmax Biopharm, Omeros Corporation, Merck Sharp & Dohme, Disc Medicine, Eledon Pharmaceuticals, Alexion AstraZeneca Rare Disease, Chinook Therapeutics, Omeros Corporation, Novo Nordisk, Merck KGaA, Bristol-Myers Squibb, Jacobio Pharmaceuticals, Nectin Therapeutics Ltd, Y-mAbs Therapeutics, OncoResponse, Inc., Fate Therapeutics, Pelican Therapeutics, Inc., Heat Biologics, Oncternal Therapeutics, Phanes Therapeutics, Pharmacyclics LLC, Immunitas Therapeutics, Hummingbird Bioscience, Inc., Sanofi, Takeda, Agenus Inc., Aulos Bioscience, Inc., ChemomAb Ltd, Celldex Therapeutics, Celgene, Janssen Research & Development, LLC, Adaptive Biotechnologies, BeiGene, Vaccinex Inc., Jasper Therapeutics, Inc., Shanghai Junshi Bioscience Co., Ltd., TopAlliance Biosciences, Inc., and others

Key Monoclonal Antibodies Pipeline Drugs: Ianalumab, GMA-131, anti-MASP-2 monoclonal antibody, MK-2060, DISC-0974, AT-1501, Ravulizumab, BION 1301, Narsoplimab, Pembrolizumab, Ziltivekimab, Opdivo, Avelumab, JAB-BX102, and others

Company Analysis, Therapeutic Assessment, Pipeline Assessment, Inactive drugs assessment, Unmet Needs

Dive deep into rich insights for new drugs for monoclonal antibodies treatment, visit @ Monoclonal Antibodies Drugs

Table of Contents

1.

Monoclonal Antibodies Pipeline Report Introduction

2.

Monoclonal Antibodies Pipeline Report Executive Summary

3.

Monoclonal Antibodies Pipeline: Overview

4.

Monoclonal Antibodies Marketed Drugs

4.1.

OPDIVO: Bristol-Myers Squibb

5.

Monoclonal Antibodies Clinical Trial Therapeutics

6.

Monoclonal Antibodies Pipeline: Late-Stage Products (Pre-registration)

7.

Monoclonal Antibodies Pipeline: Late-Stage Products (Phase III)

7.1.

Ianalumab: Novartis

8.

Monoclonal Antibodies Pipeline: Mid-Stage Products (Phase II)

8.1.

Iscalimab: Novartis

9.

Monoclonal Antibodies Pipeline: Early-Stage Products (Phase I/II)

9.1.

BION-1301: Chinook Therapeutics

10.

Monoclonal Antibodies Pipeline Therapeutics Assessment

11.

Inactive Products in the Monoclonal Antibodies Pipeline

12.

Company-University Collaborations (Licensing/Partnering) Analysis

13.

Unmet Needs

14.

Monoclonal Antibodies Market Drivers and Barriers

15.

Appendix

For further information on the monoclonal antibodies pipeline therapeutics, reach out @ Monoclonal Antibodies Treatment Drugs

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For more insights, visit our blog section @ Healthcare Blogs

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences.

Contact UsShruti Thakur [email protected]+1(919)321-6187www.delveinsight.com

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SOURCE DelveInsight Business Research, LLP