Exosomes - Pipeline Insight, 2024

This “Exosomes- Pipeline Insight, 2024” report provides comprehensive insights about 66+ companies and 75+ 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

CAP-1002 consists of allogeneic cardiosphere-derived cells (CDCs), a population of stromal cells that have been shown in preclinical and clinical studies to exert potent immunomodulatory, antifibrotic and regenerative actions in dystrophinopathy and heart failure. CDCs act by secreting extracellular vesicles known as exosomes, which target macrophages and alter their expression profile so that they adopt a healing, rather than a pro-inflammatory, phenotype.

CAP-1002 is being developed by Capricor Therapeutics and is currently being evaluated in Phase III for Duchenne muscular dystrophy, Phase II for COVID infections, and Phase I/II for cardiomyopathies.

• AGLE-102: Aegle Therapeutics

AGLE-102 is an investigational product comprised of extracellular vesicles isolated from allogeneic stem cells using Aegle's proprietary and patented methods. The product is a composite of native EVs and their associated complex assemblies of biologic molecules such as proteins, peptides, ligands and nucleic acids that have the potential to induce a wide variety of effects in recipient cells, including reducing inflammation, modulating the immune system and promoting regenerative healing.

The drug is currently being evaluated under Phase I/II clinical trial for the treatment of Dystrophic epidermolysis bullosa and burns, and under preclinical stage of development for Graft-versus-host disease.

• ILB-202: ILIAS Biologics

ILIAS's lead pipeline, ILB-202, is an exosome-based therapeutics containing the anti-inflammatory protein super-repressor lκB (srlκB). It is being developed for therapeutic use in inflammatory diseases, including acute and chronic ones. SrlκB, the dominant active form of lκBα, can attenuate inflammatory responses in various disease models by inhibiting the translocation of NF-κB into the nucleus. Conventional treatments targeted only upstream signaling pathways, while ILB-202 lowers the chance of off-target effects by directly targeting cytosolic core inflammation signals.

The drug is currently being evaluated under Phase I clinical trial for inflammation and under preclinical stage of development for acute kidney injury, preterm labour, and sepsis.

• ExoAAV: Evox Therapeutics

Evox is developing an exosome-delivered AAV encoding the phenylalanine hydroxylase (PAH) enzyme, which may have several significant advantages over other gene therapy approaches. Exosome-delivered AAV significantly improves cellular delivery and increases transgene expression in animals, thereby lowering the AAV dose needed. Exosome-delivered AAV demonstrates resistance to neutralizing antibodies in animal models suggesting that repeat dosing may be possible. The drug is under preclinical stage of development for the treatment of phenylketonuria and cardiovascular diseases.

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. 66+ 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

This report covers around 75+ 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
• Regeneus
• Capricor Therapeutics
• Aegle Therapeutics
• Organicell
• Evecxia
• ArunaBio
• Evox
• Coya Therapeutics
• ILIAS Biologics
• EXO Biologics

Key Products

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

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