Systemic Lupus Erythematosus - Pipeline Insight, 2024

This “Systemic Lupus Erythematosus - Pipeline Insight, 2024” report provides comprehensive insights about 55+ companies and 60+ pipeline drugs in Systemic Lupus Erythematosus 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

Systemic Lupus Erythematosus: Understanding

Systemic Lupus Erythematosus: Overview

Systemic lupus erythematosus (SLE) is a systemic autoimmune disease with multisystem involvement and is associated with significant morbidity and mortality. Genetic, immunological, endocrine, and environmental factors influence the loss of immunological tolerance against self-antigens leading to the formation of pathogenic autoantibodies that cause tissue damage through multiple mechanisms. Several immunopathogenic pathways play a role in the development of SLE. Hargraves described the lupus erythematosus (LE cell) in 1948. Several pathogenic autoantibodies have since been identified. Despite recent advances in technology and understanding of the pathological basis and risk factors for SLE, the exact pathogenesis is still not well known. Diagnosis of SLE can be challenging, and while several classification criteria have been posed, their utility in the clinical setting is still a matter of debate. Management of SLE is dictated by organ system involvement. Despite several agents shown to be efficacious in treating SLE, the disease still poses significant morbidity and mortality risk in patients.

SLE is most commonly seen in women in the reproductive age group (frequently starting at childbearing age), although lupus is increasingly recognized after the age of 40 years, particularly in the Europeans. The disease is prone to relapses and remissions, resulting in considerable morbidity due to flares of disease activity and accumulated organ damage, and an increased risk of premature death, mostly due to infection or cardiovascular disease. SLE initially appears with symptoms such as drowsiness, illness, loss of appetite, and fever. Most of the affected patients also suffer from joint pain which typically affects the same joint on both sides of the body, weakness and muscle pain. The signs and symptoms of SLE vary among affected individuals and can involve many organs and systems, including the skin, joints, kidneys, lungs, central nervous system, and blood-forming (hematopoietic) system.

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

Systemic Lupus Erythematosus Emerging Drugs Chapters

This segment of the Systemic Lupus Erythematosus 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.

Systemic Lupus Erythematosus Emerging Drugs

Obinutuzumab (Gazyva): Roche Gazyva/Gazyvaro is an engineered monoclonal antibody designed to attach to CD20, a protein expressed on certain B cells, but not on stem cells or plasma cells. Gazyva/Gazyvaro is designed to attack and destroy targeted B-cells both directly and together with the body's immune system. Gazyva is marketed as Gazyvaro in the EU and Switzerland. Gazyva/Gazyvaro is currently approved in more than 90 countries in combination with chlorambucil for people with previously untreated chronic lymphocytic leukaemia, in more than 80 countries in combination with bendamustine for people with certain types of previously treated follicular lymphoma, and in more than 70 countries in combination with chemotherapy for previously untreated follicular lymphoma. In late 2021/early 2022, the United States, Europe and many other countries approved a new, shorter duration infusion of Gazyva/Gazyvaro, meaning the treatment can be administered to the patient over a shorter time period and can result in potential time savings for patients, as the standard rate of infusion can take approximately three to five hours. The drug is currently in Phase III stage of development to treat Systemic lupuserythematosus.

Dapirolizumab pegol: UCBDapirolizumab pegol is an investigational humanized monovalent pegylated Fab antibody fragment against the CD40 ligand (CD40L). Through interactions with its receptor, CD40, CD40L plays an important role in regulating interactions between T cells and other immune cells and thus affects several important functional events thought to be involved in autoimmune disease. Dapirolizumab pegol is being co-developed with Biogen. The drug is currently in phase III stage of development to treat SLE.

BIIB059: Biogen BIIB059, discovered and developed exclusively by Biogen, is a humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2) and is being investigated for the potential treatment of SLE. BDCA2 is a receptor that is exclusively expressed on a subset of human immune cells called Plasmacytoid Dendritic Cells (p DCs), and it has been shown to reduce inflammatory cytokine production from pDCs, including type-I IFN (IFN-I). Inflammatory mediators are thought to play a major role in the pathogenesis of lupus. The drug has successfully completed Phase II and is currently in Phase IIIforSLE.

PRV 3279: Provention Bio PRV-3279 is an investigational humanized bispecific DART molecule targeting the B-cell surface proteins, CD32B and CD79B. Simultaneous engagement of the CD32B and CD79B receptors triggers inhibition of B cell function and suppression of autoantibody production, thereby regulating B cells without causing depletion. Provention is initially developing PRV-3279 for the interception of systemic lupus erythematosus (SLE), a chronic autoimmune disorder characterized by an abnormal over activation of B cells and subsequent pathologic production of auto-antibodies. PRV-3279 also has the potential to prevent or reduce the immunogenicity of Biotherapeutics, including but not limited to gene therapy vectors and transgenes. Provention is currently evaluating PRV-3279 in the PREVAIL-2 (PRV-3279 Evaluation in Lupus)study.

ABBV-599: AbbVie ABBV-599 is a combination of ABBV-105 (BTK inhibitor) and ABT-494 (JAK1 Selective Inhibitor) under development for the treatment of Systemic Lupus Erythematosus (SLE). Upadacitinib (ABT-494) is an oral Janus kinase (JAK) 1-selective inhibitor used in the treatment of moderate to severe rheumatoid arthritis, active psoriatic arthritis, ankylosing spondylitis, and severe atopic dermatitis, including in patients who did not respond well to other therapies. The FDA approved upadacitinib in August 2019 and it is used for the treatment of active rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, and ulcerative colitis.9 In December 2019, it was additionally approved by the European Commission. Upadacitinib is marketed under the brand name RINVOQ for oral administration. ABBV-105 irreversibly inhibits BTK, demonstrating superior kinome selectivity and is potent in B cell receptor, Fc receptor, and TLR-9-dependent cellularassays.

Systemic Lupus Erythematosus: Therapeutic Assessment

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

Major Players in Systemic Lupus Erythematosus

There are approx. 55+ key companies which are developing the therapies for Systemic Lupus Erythematosus. The companies which have their Systemic Lupus Erythematosus drug candidates in the most advanced stage, i.e. Phase III include, Roche.

Phases

This report covers around 60+ 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

Systemic Lupus Erythematosus 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.

Systemic Lupus Erythematosus: Pipeline Development Activities

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

Systemic Lupus Erythematosus Report Insights

• Systemic Lupus Erythematosus Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Zenas Biopharma
• Yake Biotechnology
• UCB
• Sorrento Therapeutics
• SinoMab Bioscience Ltd
• Shanghai Junshi Biosciences
• Sareum
• Sanofi
• Roche
• Rheos Medicine
• Resolve Therapeutics
• Resolve
• Provention Bio
• Pfizer
• Novartis Pharmaceuticals
• Novartis
• Neovacs
• Merck KGaA
• Merck
• Medsenic
• Landos Biopharma
• Kezar Life Sciences
• Kangpu Biopharmaceuticals
• Janssen Research & Development
• Janssen
• InnoCare
• ImmuPharma
• I-MAB Biopharma
• ILTOO
• Idorsia Pharmaceuticals
• Horizon Therapeutics
• Genovax
• Exinda Thearapeutics
• Equillium
• Eli Lilly and Company
• Eisai
• Daiichi Sankyo Company
• Corestem
• Corbus Pharmaceuticals
• Citryll BV
• Chipscreen Biosciences
• Carna Bioscience
• Bristol-Myers Squibb
• Brickell Biotech
• Boston Pharmaceuticals
• Biogen
• Athos Therapeutics
• Asahi Kasei Pharma
• Aria Pharmaceuticals
• Antengene Therapeutics
• Amgen
• Alpine Immune Sciences
• Akeso Biopharma
• AbbVie

Key Products

• Obexelimab (XmAb5871)
• CD19/BCMA CAR T-cells
• Dapirolizumab pegol
• AC0058
• SM03
• UBP1213
• SDC-1802
• SAR441344
• Obinutuzumab
• Mosunetuzumab
• RHX-317
• RSLV-132
• RSLV-621
• PRV-3279
• PF-06700841
• PF-06835375
• MHV370
• Ianalumab
• MHS 552
• IFNa kinoid
• Enpatoran
• PT101/ MK 6194
• Arscimed
• LABP-104
• KZR-616
• KPG 818
• Nipocalimab
• JNJ 55920839
• Daratumumab
• ICP-022
• Lupuzor (IPP-201101)
• TJ202
• Aldesleukin
• Cenerimod
• Daxdilimab (VIB7734)
• GX-101
• Ex-204
• EQ001 (Itolizumab)
• NKTR-358 (LY3471851)
• LY 3361237
• E6742
• DS-7011a
• CS20AT04
• Lenabasum
• CIT-013
• CS12192
• AS-0871
• Iberdomide
• Deucravacitinib
• Branebrutinib
• BMS-986256
• BBI-10
• BOS161721
• BIIB059

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