Castleman Disease - Pipeline Insight, 2024

This “Castleman Disease- Pipeline Insight, 2024,” 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 (i MCD). Castleman disease can also be described as hyaline-vascular, plasmacytic, or mixed based on the microscopicappearance.

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 i MCD. This is the first and only FDA-approved drug to treat patients with i MCD. 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 chemotherapiesareneeded.

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 anticancertreatments.

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

This 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 Bei Gene 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 GreaterChina.

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

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