Exosome - Pipeline Insight, 2023

DelveInsight's , "Exosomes- Pipeline Insight, 2023" report provides comprehensive insights about 60+ companies and 110+ 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

An exosome is a type of extracellular vesicle (EV), a family of nanometer-scale, biomolecule-filled, lipid-wrapped packages released by most cells. Exosomes are released from cells upon fusion of an intermediate endocytic compartment, the multivesicular body (MVB), with the plasma membrane. This liberates intraluminal vesicles (ILVs) into the extracellular milieu and the vesicles thereby released are what we know as exosomes. They are found in mostly all biological fluids, such as breast milk, blood, urine, and semen. After secretion, these are taken up by distant cells, affecting cell function and behavior. Exosomes play a role in cell-cell communication and the transmission of disease states and explored as a means of drug discovery. Exosomes are generated in a process that involves double invagination of the plasma membrane and the formation of intracellular multivesicular bodies (MVBs) containing intraluminal vesicles (ILVs). ILVs are ultimately secreted as exosomes with a size range of ~40-160 nm in diameter through MVB fusion to the plasma membrane and exocytosis. Exosomes with a cell-specific cargo of proteins, lipids, and nucleic acids may act as a novel intercellular communication mechanism. This concept is based on the observation that exosomes released from parental cells may interact with target cells, leading to the subsequent influence of target cell behavior and phenotype features. The success of exosomal biological applications is highly dependent on effective delivery of genetic materials, which can be achieved via receptor-ligand interactions, a direct fusion of membranes, or internalization via endocytosis. Extensive studies are going on for the role of exosomes in the diagnosis and treatment of various pathologies-the complex cargo of exosomes, allowing a multicomponent diagnostic window into disease detection and monitoring. Also, the characteristic properties of exosomes in delivering functional cargos to diseased cells also favor their use as therapeutic vehicles. Exosomes are found in all biological fluids and are secreted by all cells, making them attractive as minimally invasive liquid biopsies with the potential for longitudinal sampling to follow disease progression. Exosome biogenesis enables capturing complex extracellular and intracellular molecular cargo for comprehensive, multiparameter diagnostic testing. Exosomes are nanoscale membrane vesicles with the exceptional ability to target specific cells or tissues. They may mediate a horizontal transfer of genetic material via the interaction of surface adhesion proteins, resulting in modified biological activities of recipient cells. Besides, exosomes can be obtained from patients' tissues or body fluids with excellent host bio-distribution and biocompatibility, which allows for diminished clearance by the mononuclear phagocyte system.

"Exosomes- Pipeline Insight, 2023" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. 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

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 Marban. 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 Phase III stage of clinical trial evaluation for the treatment of Duchenne Muscular Dystrophy.

Progenza: Regeneus

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. Currently, the drug is in Phase II stage of Clinical trial evaluation for the treatment of Osteoarthritis.

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.It is being developed by Aegle Therapeutics for Dystrophic Epidermolysis Bullosa.

Zofin: Organicell Regenerative Medicine

Zofin is an acellular, biologic therapeutic derived from perinatal sources and is manufactured to retain naturally occurring microRNAs, without the addition or combination of any other substance or diluent. This product contains over 300 growth factors, cytokines, chemokines, and 102 unique microRNAs as well as other exosomes/nanoparticles derived from perinatal tissues. Zofin is currently being tested in a phase I/II randomized, double blinded, placebo trial to evaluate the safety and potential efficacy of intravenous infusion of Zofin for the treatment of moderate to SARS related to COVID-19 infection vs placebo.

Exo-101: Exogenus Therapeutics

Exogenus developed a product Exo-101, based on vesicles released by mononuclear cells from umbilical cord blood, which shows promise for regenerative medicine (namely healing of chronic wounds) and inflammatory diseases. Known for their capacity to travel long distances within the body and support cellular communication, these nano-sized vesicles are also thought to be safer than cellular therapies, while maintaining similar efficacy. Due to its immunomodulatory properties, Exo-101 is being explored for inflammatory skin diseases, such as psoriasis. The combination of pro-regenerative and anti-inflammatory potential of Exo-101 may benefit patients with inflammatory lung diseases, including COVID-19-related respiratory complications. Exo-101 has been shown to accelerate the healing of chronic wounds.

COYA 201: Coya Therapeutics

COYA 201 product candidate utilizes Treg-derived exosome therapeutic modality. For COYA 201, the company is currently completing animal model studies and will conduct pharmacology, toxicology and other IND-enabling studies to support the initiation of clinical trials in neurodegenerative, autoimmune and metabolic diseases.

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

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. 60+ 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.

Phases

DelveInsight's report covers around 110+ 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
• Ophthalmic
• 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

• Capricor Therapeutics
• Direct Biologics
• Regeneus
• OBCTCD24
• AVEM HealthCare
• Cellular Biomedicine Group
• Aegle Therapeutics
• Organicell Regenerative Medicine
• Codiak BioSciences
• Cellular Biomedicine Group
• StemXO Therapeutics
• Cells for Cells
• RION
• Cell Care Therapeutics
• Novadip
• Ilias
• Ilias
• ReNeuron
• Evora Bioscineces
• Coya Therapeutics
• ShiftBio Inc.
• Exostemtech
• Celularity
• Azymus Therapeutics

Key Products

• ExoFlo
• Progenza
• EXO-CD24
• Mesenchymal stem cells (MSCs) exosomes
• Mesenchymal progenitor cells (MPCs) derived exosomes
• AGLE 102
• Zofin
• exoSTING
• Mesenchymal stem cells (MSCs) exosomes
• StemXO Endosome Therapy
• StemXO Antiviral Endosome Therapy
• MSC-derived Exosomes
• PEP
• exoIL 12
• ILB 202
• Mesenchymal stem cell exosome therapeutic
• BRE AD01
• exoASO-STAT6
• VT 105
• CAP 2003
• Exo-101
• XO NEUR
• COYA 201
• Exosome therapeutics
• Exosome NRAS
• Red Cell EV Gene Therapy
• Inhaled gene therapy program
• ExoSCRT Exosome
• SBI-101
• SBI-102
• NurOwn-derived exosomes
• EV-102
• ExoCoVac
• PrrsvExoVac
• StemVacs Derived Exosomes
• Research Program: Exosome-based therapies in genetic disorders
• IPF Lamellasome
• Muco-ease
• Research programme: exosome
• NXS-1001
• NXS-1002
• NXS-1003
• exoVACC
• EVX-102
• EVX-101
• Human placental amniotic epithelial stem cells (hAECs)
• MVR-Exo
• MVR-Exn
• EXO-GF
• EXO-cas
• Engineered EVs
• BRE-NA01
• BRE-RF01
• EVX-103
• Undisclosed Target
• engEx-AAV
• Engineered Exosomes
• Research Programme: Exosomes
• Exosome therapeutics
• CCT-101
• miRNAs/Exosome Therapeutics
• Exosome loaded with Intracellular antibody
• Engineered Exosomes
• Research programme: Small molecule
• Exosome based therapies
• Coya 201