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AL Amyloidosis - Pipeline Insight, 2021

July 2021 | 60 pages | ID: AEB126C9CE18EN
DelveInsight

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DelveInsight’s, “AL Amyloidosis – Pipeline Insight, 2021,” report provides comprehensive insights about 15+ companies and 15+ pipeline drugs in AL Amyloidosis 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
AL Amyloidosis Understanding

AL Amyloidosis: Overview

Amyloidosis is a rare and serious protein deposition disease. It is caused by an abnormal protein called amyloid that builds up in tissues or organs. As the amount of amyloid protein deposits increase in a tissue or organ, they interfere with the tissue or organ’s healthy function. Eventually, the amyloid protein deposits cause symptoms and organ failure. This is the most common type of amyloidosis in the United States. The amyloid proteins that build up in the tissues in this condition are known as light chains. They can either be kappa or lambda light chains. AL amyloidosis is a disorder of the plasma cells. Plasma cells are a type of white blood cell responsible for the production of immunoglobulins or antibodies, which are a type of protein that fights infection. In AL amyloidosis, the light chain proteins are misshapen and produced in excess. They deposit in tissues and can damage 1 or more organs. The heart, kidneys, nerves, and gastrointestinal system are the most common organs affected. Diagnostic testing for AL amyloidosis involves blood tests, urine tests and biopsies. Blood and/or urine tests can indicate signs of the amyloid protein, but only bone marrow tests or other small biopsy samples of tissue or organs can positively confirm the diagnosis of amyloidosis. Treatment for AL amyloidosis is tailored to the patient with their individual health in mind. The type of treatment is based upon disease progression and seriousness of the patient’s organ, tissue and nerve involvement. Treatment plans are two-fold: Supportive treatment – treating your symptoms and organ damage; and, Source treatment – slowing down, or stopping, the overproduction of amyloid at the source of the disease.

'AL Amyloidosis - Pipeline Insight, 2021' report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the AL Amyloidosis pipeline landscape is provided which includes the disease overview and AL Amyloidosis treatment guidelines. The assessment part of the report embraces, in depth AL Amyloidosis 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, AL Amyloidosis 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 AL Amyloidosis R&D. The therapies under development are focused on novel approaches to treat/improve AL Amyloidosis.
AL Amyloidosis Emerging Drugs Chapters

This segment of the AL Amyloidosis 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.

AL Amyloidosis Emerging Drugs
  • CAEL-101: Caelum Biosciences
CAEL-101 is a first-in-class anti-amyloid antibody designed to improve organ function by reducing or eliminating amyloid deposits in patients with amyloid light chain (AL) amyloidosis. Alexion is collaborating with Caelum Biosciences to develop CAEL-101 for light chain (AL) amyloidosis, a rare systemic disorder that causes misfolded immunoglobulin light chain protein to build up in and around tissues, resulting in progressive and widespread organ damage. Alexion and Caelum Biosciences are conducting the Cardiac Amyloid Reaching for Extended Survival (CARES) Phase 3 clinical program to evaluate CAEL-101, a first-in-class amyloid fibril targeted therapy, in combination with standard-of-care therapy in AL amyloidosis. CAEL-101 has received Orphan Drug Designation from both the U.S. Food and Drug Administration and European Medicine Agency as a therapy for patients with AL amyloidosis.
  • Ixazomib: Takeda
Ninlaro (ixazomib) is a proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome. Ixazomib induced apoptosis of multiple myeloma cell lines in vitro. The drug is being evaluated in Phase III stage of development for the treatment of patients with AL Amyloidosis.
  • Belantamab mafodotin: GlaxoSmithKline
Belantamab mafodotin, or GSK2857916, is an afucosylated monoclonal antibody that targets B cell maturation antigen (BCMA) conjugated to the microtubule distrupter monomethyl auristatin-F (MMAF).1 Afucosylation of the Fc region of monoclonal antibodies enhances binding to the Fc region, which enhances antibody dependant cell mediated cytoxicity. Phase II clinical Study of Belantamab Mafodotin has been initiated to treat Patients with Relapsed or Refractory AL Amyloidosis.

Further product details are provided in the report……..

AL Amyloidosis: Therapeutic Assessment

This segment of the report provides insights about the different AL Amyloidosis drugs segregated based on following parameters that define the scope of the report, such as:
  • Major Players in AL Amyloidosis
There are approx. 15+ key companies which are developing the therapies for AL Amyloidosis. The companies which have their AL Amyloidosis drug candidates in the most advanced stage, i.e. Phase III include, Caelum Biosciences.
  • Phases
DelveInsight’s report covers around 15+ 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
AL Amyloidosis 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
  • Intravenous
  • Subcutaneous
  • 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.

AL Amyloidosis: Pipeline Development Activities

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

AL Amyloidosis Report Insights
  • AL Amyloidosis Pipeline Analysis
  • Therapeutic Assessment
  • Unmet Needs
  • Impact of Drugs
AL Amyloidosis 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 AL Amyloidosis drugs?
  • How many AL Amyloidosis drugs are developed by each company?
  • How many emerging drugs are in mid-stage, and late-stage of development for the treatment of AL Amyloidosis?
  • What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the AL Amyloidosis 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 AL Amyloidosis and their status?
  • What are the key designations that have been granted to the emerging drugs?
Introduction
Executive Summary
AL Amyloidosis: 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
Late Stage Products (Phase III)
  Comparative Analysis
CAEL-101: Caelum Biosciences
  Product Description
  Research and Development
  Product Development Activities
Drug profiles in the detailed report…..
Mid Stage Products (Phase II)
  Comparative Analysis
Belantamab mafodotin: GlaxoSmithKline
  Product Description
  Research and Development
  Product Development Activities
Drug profiles in the detailed report…..
Early stage products (Phase I/II)
  Comparative Analysis
Genakumab: GeneScience Pharmaceuticals
  Product Description
  Research and Development
  Product Development Activities
Drug profiles in the detailed report…..
Inactive Products
  Comparative Analysis
AL Amyloidosis Key Companies
AL Amyloidosis Key Products
AL Amyloidosis- Unmet Needs
AL Amyloidosis- Market Drivers and Barriers
AL Amyloidosis- Future Perspectives and Conclusion
AL Amyloidosis Analyst Views
AL Amyloidosis Key Companies
Appendix


LIST OF TABLES

Table 1 Total Products for AL Amyloidosis
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 AL Amyloidosis
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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