DelveInsight’s, “AL Amyloidosis Pipeline Insight, 2022,” report provides comprehensive insights about 10+ companies and 10+ pipeline drugs in AL Amyloidosis pipeline landscape.

 

AL Amyloidosis Pipeline landscape is provided which includes the disease overview and AL Amyloidosis treatment guidelines. The assessment part of the AL Amyloidosis pipeline report embraces, in depth AL Amyloidosis commercial assessment and clinical assessment of the pipeline products under development. In the AL Amyloidosis Pipeline 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.

 

Key takeaways from the AL Amyloidosis Pipeline Report

• DelveInsight’s AL Amyloidosis Pipeline report depicts a robust space with 10+ active players working to develop 10+ pipeline therapies for various indications.
• Globally, leading AL Amyloidosis companies such as Merck & Co, Janssen Pharmaceutical, Caelum Biosciences, Oncopeptides AB, Bristol-Myers Squibb, Acrotech biopharma, Sanofi, Astellas Pharma GmbH, Prothena, Alexion Pharmaceuticals, Celgene Corporation, and others are developing novel AL amyloidosis drugs that can be available in the AL amyloidosis market in the coming years.
• The promising AL amyloidosis therapies in the pipeline include Daratumumab, Birtamimab, CAEL-101, Melflufen, Elotuzumab, Evomela, Pomalidomide, and others.
• In recent decades, the current understanding of AL amyloidosis has improved, leading to growing awareness, improved management, and better outcomes.
• 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.

 

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The AL Amyloidosis Pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage AL Amyloidosis, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the AL Amyloidosis Pipeline Landscape.

 

AL Amyloidosis Overview

Amyloid light-chain amyloidosis, (AL) is the most common form of systemic amyloidosis and is associated with an underlying plasma cell dyscrasia. AL amyloidosis is caused by a bone marrow disorder.  The bone marrow in the center of bones produces cells in the blood system, including “plasma cells.”  These plasma cells are the part of the immune system that makes antibodies for fighting infections.  The term “immunoglobulin” refers to the class of proteins that function as antibodies. Immunoglobulins are composed of four protein chains: two light chains, eitherkappa or lambda light chains, and two heavy chains, of which there are several types. These proteins are produced by the plasma cells in the bone marrow.

In AL patients, these plasma cells produce an abnormal antibody (immunoglobulin) protein. For AL amyloidosis, it is the “light chains” that become misfolded, and the abnormal, misfolded result is the forming of amyloid.  With AL amyloidosis, the “A” is for amyloid and the “L” is for light chain. The symptoms of AL amyloidosis vary by patient. Initially, the symptoms can be minor or similar to those of many other conditions or systemic diseases.  Some symptoms can announce themselves quickly and be very noticeable.  For each patient, the symptoms will depend on which organs are affected by the amyloid deposits.  It also depends on the degree that the organ function is impaired. Fatigue, weight loss and swelling are the most common symptoms.

 

Latest Breakthroughs and Developments in the AL Amyloidosis Treatment Landscape

• In January 2019, Alexion Pharmaceuticals and Caelum Biosciences declared a collaboration to develop CAEL-101 for light chain (AL) amyloidosis.
• CAEL-101 has secured Orphan Drug Designation from both the US Food and Drug Administration (FDA)  and European Medicine Agency as a therapy for AL amyloidosis patients.
• In May 2020, Sorrento Therapeutics announced it had received clearance from the FDA for its investigational new drug (IND) application for STI-6129.

 

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.

• STI 6129 : Sorrento Therapeutics

STI-6129 is an ADC with covalently bound duostatin tubulin inhibitors (Duostatin 5) using a proprietary site-specific C-LOCK™ chemical linker designed to reduce the premature systemic release of duostatin and avoid the potential for toxicity, particular ocular toxicity, seen with other ADCs, especially first-generation products. STI-6129 has demonstrated an improved therapeutic index in animal models, as compared to traditional non-selective conjugates. STI-6129 has the potential for being a first-line treatment for amyloidosis as wecll as second line in those patients who have developed daratumumab resistance, an anti-CD38 mAb alone. STI-6129 binds to different epitopes than daratumumab and the addition of the targeted delivery of the duostatin can potentially manage those patients who have become refractory to such treatments.

 

AL Amyloidosis Pipeline Analysis Report

• The report provides detailed insights about emerging therapies for the AL Amyloidosis treatment and the aggregate therapies developed by major pharma companies.
• It accesses the different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for AL Amyloidosis Treatment.
• It outlines the key companies involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• The AL Amyloidosis Pipeline Report evaluates the drugs that are under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
• It navigates the major collaborations (company-company collaborations and company-academia collaborations), licensing agreements, financing details, data presentation by the pharma giants, and regulatory approval in the AL Amyloidosis market.

The AL Amyloidosis Pipeline Report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources etc.

 

Scope of the AL Amyloidosis Pipeline Report

• Coverage- Global
• AL Amyloidosis Phases- 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
• AL Amyloidosis Route of Administration– Intra-articular, Intraocular, Intrathecal, Intravenous, Ophthalmic, Oral, Parenteral, Subcutaneous, Topical, Transdermal
• AL Amyloidosis Molecule Type- Oligonucleotide, Peptide, Small Molecule
• AL Amyloidosis Companies- Merck & Co, Janssen Pharmaceutical, Caelum Biosciences, Oncopeptides AB, Bristol-Myers Squibb, Acrotech biopharma, Sanofi, Astellas Pharma GmbH, Prothena, Alexion Pharmaceuticals, Celgene Corporation, and many others
• AL Amyloidosis Therapies- Daratumumab, Birtamimab, CAEL-101, Melflufen, Elotuzumab, Evomela, Pomalidomide, and many others

 

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Table of Content

1. Introduction
2. Executive Summary
3. AL Amyloidosis: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. AL Amyloidosis– DelveInsight’s Analytical Perspective
7. Late Stage Products (Phase III)
8. CAEL-101: Caelum Biosciences
9. Mid Stage Products (Phase II)
10. Belantamab mafodotin: GlaxoSmithKline
11. Early Stage Products (Phase I)
12. STI-6129: Sorrento Therapeutics
13. Preclinical and Discovery Stage Products
14. Drug name: Company Name
15. Inactive Products
16. AL Amyloidosis Key Companies
17. AL Amyloidosis Key Products
18. AL Amyloidosis- Unmet Needs
19. AL Amyloidosis- Market Drivers and Barriers
20. AL Amyloidosis- Future Perspectives and Conclusion
21. AL Amyloidosis Analyst Views
22. AL Amyloidosis Key Companies
23. Appendix

 

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