Exosomes - Pipeline Insight, 2024

This “Exosomes - Pipeline Insight, 2024” report provides comprehensive insights about 80+ companies and 100+ pipeline drugs in Exosomes 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

Exosomes: Understanding

Exosomes: Overview

Exosomes are classified as small (30-150 nm), phospholipid bilayer extracellular vehicles (EVs), which are released by both eukaryotic and prokaryotic cells for the purpose of intercellular communication and signaling. Initially, exosomes were identified as EVs used for excreting unwanted cellular waste-however, studies found that exosomes are important molecular mediators in cellular communication through their ability to transport proteins, metabolites, and various nucleic acids across the body.

Exosomes are associated with immune responses, viral pathogenicity, pregnancy, cardiovascular diseases, central nervous system-related diseases, and cancer progression. Proteins, metabolites, and nucleic acids delivered by exosomes into recipient cells effectively alter their biological response. Such exosome-mediated responses can be disease promoting or restraining. The intrinsic properties of exosomes in regulating complex intracellular pathways has advanced their potential utility in the therapeutic control of many diseases, including neurodegenerative conditions and cancer. Exosomes can be engineered to deliver diverse therapeutic payloads, including short interfering RNAs, antisense oligonucleotides, chemotherapeutic agents, and immune modulators, with an ability to direct their delivery to a desired target.

The therapeutic application of exosomes includes, them being used as biomarkers that help diagnose a disease and the follow-up procedures, drug delivery vehicles or therapeutic agents, and immunomodulators that stimulate or suppress the immune system. Exosomes represent a mode of intercellular communication through various active biomolecules, including lipids, cytokines, growth factors, metabolites, proteins, and RNAs, during normal and pathological processes. Exosomes ability to modulate cellular communications and intracellular pathways has advanced their potential for controlling many diseases.

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

Exosomes Emerging Drugs Chapters

This segment of the Exosomes 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.

Exosomes Emerging Drugs

CAP-1002: Capricor Therapeutics

Capricor’s (CAP-1002) is based on cardiosphere-derived cells, or CDCs, a cardiac-derived cell therapy that was first identified in the academic laboratory of Capricor’s scientific founder, Dr. Eduardo Marbán. CDCs have been the subject of over 100 peer-reviewed scientific publications and have been administered to over 200 human subjects across several clinical trials. CAP-1002 contains cardiosphere-derived cells, a type of heart cell progenitor, or precursor cell, that secretes tiny vesicles called exosomes. These exosomes then modulate the activity of the immune system and stimulate cellular regeneration. It is being investigated for its potential to modify the immune system’s activity to encourage cellular regeneration. The cells function by releasing exosomes that are taken up largely by macrophages and T-cells and begin a cycle of repair. Currently the drug is in the Phase III stage of clinical trial evaluation for the treatment of Duchenne Muscular Dystrophy.

EXO-CD24: Nano24

EXO-CD24 (CovenD24), is an investigational drug being developed by Nano24. The company has developed a new anti-inflammatory drug, EXO-CD24, a combination of an immune checkpoint (CD24) and a delivery platform (exosomes). CD24 inhibits the NF-kB pathway and the production of cytokines/chemokines. EXO-CD24 discriminates damage-from pathogen-associated molecular patterns (DAMPs and PAMPs) therefore does not interfere with viral clearance. EXO-CD24 was produced and purified from CD24-expressing 293-TREx™ cells. Exosomes displaying murine CD24 (mCD24) were also created.

EXO-CD24 is the new immunomodulator with promising efficacy without interfering with pathogen clearance. Nano24 developed CD24-enriched exosomes, named EXO-CD24, as a targeted therapy for hyperimmune activation in the context of COVID-19. CD24, which dampens cytokines and chemokines production while not interfering with pathogen clearance, is of particular interest as a therapeutic agent for virus-induced hyper-inflammation and ARDS. EXO-CD24, and its mouse homolog EXO-mCD24, is a new precision nanotechnology that can target and prevent the cytokine storm in the lungs. Nano24 is developing a pipeline of CD24-based exosomes aimed at treating COVID-19 with EXO-CD24, a therapeutic directly inhaled to the lungs, as well as a broad range of disease areas, spanning ARDS, respiratory, and autoimmune disease. Currently, the drug is in Phase II stage of Clinical trial evaluation for the treatment of Acute Respiratory Disease Syndrome (ARDS).

AGLE-102: Aegle Therapeutics

AGLE 102 is an allogeneic derived extracellular vesicle (EV) product derived from normal donor mesenchymal stem cells (MSCs). AGLE-102 is a composite of mesenchymal stem cell-derived extracellular vesicles that deliver proteins, genetic material and regenerative healing factors to diseased and damaged tissue. The drug is being developed in the Phase I/II stage of its development for the treatment of Burns and Epidermolysis bullosa dystrophica. The drug is also in the preclinical stage of its development for the Graft vs. Host Disease.

Progenza: Cambium Bio

Progenza is an off-the-shelf allogeneic stem cell product with the first targeted treatment being for knee osteoarthritis. The product is produced from mesenchymal stem cells (MSCs) from adipose (fat) tissue from a healthy donor who has been extensively screened. Progenza includes secretions from donor MSCs that improves viability and functionality of the cells after freezing.

Adipose tissue is readily available from donors in large quantities and has significantly higher MSCs per gram of tissue than other tissue sources such as bone marrow or cord tissue. Adipose derived MSCs also have the added advantage of showing greater capacity for expansion than MSCs from other tissue types.

The MSCs are expanded through the company's proprietary and scalable manufacturing process. The company has demonstrated the capacity to produce millions of therapeutic doses of Progenza from a single donor. When Progenza cells are injected into the damaged joint or tissue, the MSCs have the potential to reduce pain and inflammation and slow the progression of disease. As per the company’s pipeline the drug is in the Phase I stage of Clinical trial evaluation for the treatment of Osteoarthritis.

EV-101: EV Therapeutics

EV Therapeutics is a pre-clinical stage immuno-oncology biotechnology company devoted to developing first-in-class therapies based on modified tumor extracellular vesicles (mTEVs) to significantly transform cancer therapy and other unmet medical needs that are addressable with its proprietary technology platform. The leading candidate EV101, has demonstrated pre-clinical efficacy across solid tumor and advanced metastatic animal models both as a monotherapy and combination therapy with checkpoint inhibitors.

EV-101 is currently being evaluated in combination with immune checkpoint inhibitors for the treatment of advanced metastatic colorectal cancer and as a monotherapy for the treatment of minimal residual disease. The researchers tested tumor-secreted exosomes without immunosuppressive microRNAs, in combination with immune checkpoint inhibitors, as a novel combination therapy in preclinical models with advanced-stage colorectal cancer, which proved effective. EV Therapeutics's mTEV platform is available for licensing and/or co-development opportunities. Currently the drug is in preclinical stage of its development.

Exosomes: Therapeutic Assessment

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

Major Players in Exosomes

There are approx. 80+ key companies which are developing the therapies for Exosomes. The companies which have their Exosomes drug candidates in the most advanced stage, i.e. Phase III include, Capricor Therapeutics.

Phases

The report covers around 100+ 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

Exosomes 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
• 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.

Exosomes: Pipeline Development Activities

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

Exosomes Report Insights

• Exosomes Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Celularity
• EVerZom
• Direct Biologics
• Cambium Bio
• Capricor Therapeutics
• Aegle Therapeutics
• Organicell
• Evecxia
• ArunaBio
• Evox
• Coya Therapeutics
• ILIAS Biologics
• EV Therapeutics
• Nano24

Key Products

• pEXO-001
• EVerGel
• ExoFlo
• Progenza
• CAP-1002
• AGLE-102
• Zofin
• EVX-101
• AB126
• ExoAAV
• COYA-201
• ILB-202
• EV-101
• EXO-CD24

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