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Castleman Disease - Pipeline Insight - 2020

November 2020 | 40 pages | ID: CEF7CEB93C0DEN
DelveInsight

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DelveInsight’s, “Castleman Disease– Pipeline Insight, 2020,” report provides comprehensive insights about 3+ companies and 3+ pipeline drugs in Castleman Disease 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

Castleman Disease Understanding

Castleman Disease: Overview

Castleman disease describes a group of disorders with a wide range of symptoms that each has enlarged lymph nodes that share similar appearances when reviewed under the microscope. Castleman disease is first classified based on the number of regions of enlarged lymph nodes that demonstrate these abnormal features. Unicentric Castleman disease (UCD) involves a single enlarged lymph node or single region of enlarged lymph nodes whereas multicentric Castleman disease (MCD) involves multiple regions of enlarged lymph nodes. There are two sub-types of MCD. A subset of MCD is caused by human herpesvirus-8 (HHV-8; also known as Kaposi sarcoma–associated herpesvirus). These cases are called HHV-8-associated MCD. There are also MCD patients who are negative for the HHV-8 virus, and the cause is unknown. These cases are called HHV-8 negative or “idiopathic” MCD (iMCD). Castleman disease can also be described as hyaline-vascular, plasmacytic, or mixed based on the microscopic appearance.

Symptoms

The symptoms of Castleman Disease include:
  • Unicentric Castleman Disease is characterized by a single enlarged lymph node or multiple enlarged lymph nodes in a single region of the body, such as the chest, abdomen, or neck.
  • These symptoms are seen in Multicentric Castleman Disease. Fever, fatigue, excessive sweating, weight loss, skin rash, early destruction of red blood cells, leading to unusually low levels of circulating red blood cells (hemolytic anemia), and/or abnormally elevated amounts of certain immune factors in the blood (hypergammaglobulinemia).
Diagnosis

Most UCD patients do not experience systemic symptoms. Typically, the enlarged lymph node will be discovered inadvertently, during care for another condition, or because it is impeding on nearby organs. UCD is diagnosed by histopathological examination of the excised lymph node. There are no official diagnostic criteria for HHV-8-associated MCD. It is generally diagnosed when a patient has multiple regions of enlarged lymph nodes, inflammatory symptoms, biopsy of the lymph node demonstrates “Castleman-like” features under the microscope, and HHV-8 testing is positive. The diagnosis of all forms of Castleman disease should be based upon a thorough clinical evaluation that includes a detailed patient history and a variety of specialized imaging techniques (e.g., computer-assisted tomography [CT scan], magnetic resonance imaging [MRI], and ultrasonography).

Treatment

For localized (unicentric) disease, surgical removal of the affected lymph node(s) usually results in cure. However, recurrences of UCD have been reported. In some cases, ionizing radiation (radiotherapy) has proven effective. New therapies include drugs which target and neutralize IL-6 (siltuximab or Sylvant) or the receptor for IL-6 (tocilizumab or Actemra). In 2014, Sylvant (siltuximab) was approved to treat patients with iMCD. This is the first and only FDA-approved drug to treat patients with iMCD. Additional symptomatic and supportive therapy may include corticosteroids or autologous bone marrow transplantation (used most frequently for severe disease or iMCD associated with POEMS syndrome). For HHV-8-associated MCD, rituximab to eliminate a type of immune cell called the B lymphocyte is often used. It is highly effective for HHV-8-associated MCD, but occasionally antivirals and/or cytotoxic chemotherapies are needed.

Castleman Disease Emerging Drugs Chapters

This segment of the Castleman DIsease 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.

Castleman Disease Emerging Drugs
  • Silmitasertib: Senhwa Biosciences
Clinical observations show that Silmitasertib (CX-4945) hits the CK2 target and modulates the expected pathways without displaying toxicity. CX-4945 achieved clinical benefit as a single agent CK2 inhibitor, demonstrating stable disease and extended duration on treatment in a several patients. A combination of CX-4945 with the DNA damaging agents such as gemcitabine (Gemzar) plus cisplatin (Platinol), has been shown to act synergistically to improve the efficacy of these anticancer treatments.

Further product details are provided in the report

Castleman Disease: Therapeutic Assessment

This segment of the report provides insights about the different Castleman Disease drugs segregated based on following parameters that define the scope of the report, such as:
  • Major Players Castleman Disease
There are approx. 3+ key companies which are developing the therapies for Castleman Disease. The companies which have their Castleman Disease drug candidates in the most advanced stage, i.e. phase III include, Senhwa Biosciences.
  • Phases
DelveInsight’s report covers around 3+ 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
Castleman Disease pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as
  • Oral
  • Parenteral
  • intravitreal
  • Subretinal
  • Topical.
  • Molecule Type
Products have been categorized under various Molecule types such as
  • Monoclonal Antibody
  • Peptides
  • Polymer
  • Small molecule
  • Gene therapy
  • Product Type
Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Castleman Disease: Pipeline Development Activities

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

Report Highlights
  • The companies and academics are working to assess challenges and seek opportunities that could influence Castleman Disease R&D. The therapies under development are focused on novel approaches to treat/improve Castleman Disease.
  • EUSA Pharma and BeiGene in January 2020 has announced that they have entered into an exclusive development and commercialization agreement for the orphan biologic products SYLVANT (siltuximab) and QARZIBA (dinutuximab beta) in Greater China.
Castleman Disease Report Insights
  • Castleman Disease Pipeline Analysis
  • Therapeutic Assessment
  • Unmet Needs
  • Impact of Drugs
Castleman Disease 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 Castleman Disease drugs?
  • How many Castleman Disease drugs are developed by each company?
  • How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Castleman Disease?
  • What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Castleman Disease 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 Castleman Disease and their status?
  • What are the key designations that have been granted to the emerging drugs?
Key Players
  • Senhwa Biosciences
Key Products
  • Silmitasertib
Introduction
Executive Summary
Castleman Disease: Overview
  Causes
  Mechanism of Action
  Signs and Symptoms
  Diagnosis
  Disease Management
Pipeline Therapeutics
  Comparative Analysis
Therapeutic Assessment
  Assessment by Product Type
  Assessment by Stage and Product Type
  Assessment by Route of Administration
  Assessment by Stage and Route of Administration
  Assessment by Molecule Type
  Assessment by Stage and Molecule Type
Castleman Disease – DelveInsight’s Analytical Perspective
In-depth Commercial Assessment
  Castleman Disease companies’ collaborations, Licensing, Acquisition -Deal Value Trends
Castleman Disease Collaboration Deals
  Company-Company Collaborations (Licensing / Partnering) Analysis
  Company-University Collaborations (Licensing / Partnering) Analysis
Late Stage Products (Phase III)
  Comparative Analysis
Drug Name: Company Name
  Product Description
  Research and Development
  Product Development Activities
Mid Stage Products (Phase II)
  Comparative Analysis
Drug Name: Company Name
  Product Description
  Research and Development
  Product Development Activities
Drug profiles in the detailed report
Early Stage Products (Phase I)
  Comparative Analysis
Silmitasertib: Senhwa Biosciences
  Product Description
  Research and Development
  Product Development Activities
Drug profiles in the detailed report
Pre-clinical and Discovery Stage Products
  Comparative Analysis
Drug Name: Company Name
  Product Description
  Research and Development
  Product Development Activities
Drug profiles in the detailed report
Inactive Products
  Comparative Analysis
Castleman Disease Key Companies
Castleman Disease Key Products
Castleman Disease- Unmet Needs
Castleman Disease- Market Drivers and Barriers
Castleman Disease- Future Perspectives and Conclusion
Castleman Disease Analyst Views
Castleman Disease Key Companies
Appendix

LIST OF TABLES

Table 1 Total Products for Castleman Disease
Table 2 Late Stage Products
Table 3 Mid Stage Products
Table 4 Early Stage Products
Table 5 Pre-clinical & Discovery Stage Products
Table 6 Assessment by Product Type
Table 7 Assessment by Stage and Product Type
Table 8 Assessment by Route of Administration
Table 9 Assessment by Stage and Route of Administration
Table 10 Assessment by Molecule Type
Table 11 Assessment by Stage and Molecule Type
Table 12 Inactive Products

LIST OF FIGURES

Figure 1 Total Products for Castleman Disease
Figure 2 Late Stage Products
Figure 3 Mid Stage Products
Figure 4 Early Stage Products
Figure 5 Preclinical and Discovery Stage Products
Figure 6 Assessment by Product Type
Figure 7 Assessment by Stage and Product Type
Figure 8 Assessment by Route of Administration
Figure 9 Assessment by Stage and Route of Administration
Figure 10 Assessment by Molecule Type
Figure 11 Assessment by Stage and Molecule Type
Figure 12 Inactive Products


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