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Our laboratory was among the first to show that neurodegenerative disease progression and outcomes are driven by a hyper immune response as a byproduct of dysfunctional Tregs

Coya has developed proprietary manufacturing processes that, ex vivo (outside the body) isolates and “repairs” these dysfunctional Tregs followed by massive expansion into the billions of highly functional and neuroprotective Tregs for infusion back to the patient


Significantly boosting Treg function and quantity has the potential to halt a harmful inflammatory response which drives neurodegeneration by targeting the immune cascade upstream of many immunomodulatory pathways

Tregs Overview

The Master Regulatory Cell of the Immune System

Key discovery by Shimon Sakaguchi M.D., Ph.D., member of Coya’s Scientific Advisory Board:

autoimmunity
Reduction and Loss of Treg Population
  • Loss of homeostasis and peripheral tolerance
  • Loss of immune response regulationto prevent non-specific side effects
  • Promotes autoimmunity andautoimmune diseases
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Balanced Treg and inflammatory immune cell populations:
  • Promotes homeostasis and peripheral tolerance
  • Regulates immune response to prevent non-specific side effects
  • Permits cancer immuno-surveillance
cancer
Increase of Treg population

  • Loss of cancer immuno-surveillance
  • Promotes suppression of anti-tumor response
  • Promotes cancer progression


Tregs are the most versatile and important immunosuppressive cells that regulate immune response and establish peripheral tolerance.

Tregs not only maintain immune response but are key players in resolving tissue inflammation as mediators of tissue healing.
 tregcell Treg cell        Inflammatory Immune cell Inflammatory Immune Cell

Discovery that Treg dysfunction is a core driver of Neurodegenerative Disease

Treg Function Predicts ALS Survival, Disease Progression, and Burden of Disease

 Survival  survival
Survival to 100 AALS Points  survival to 100AALS points

Treg dysfunction is also central to Alzheimer’s Disease, Parkinson’s Disease, and Frontotemporal Dementia*

 

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Source: Molecular Neurodegeneration volume 15, Article number: 32 (2020)

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Scientific Rationale for Treg Intervention in Neurodegeneration: Unlocking New Treatment Options

Neuroinflammation underlies neurodegeneration, which is driven by an imbalanced ratio of pro-inflammatory effector T cells and Tregs

Impacted by high degree of dysfunctional Tregs

Treg driven inflammation drives numerous diseases:

  • Alzheimer’s Disease
  • Amyotrophic Lateral Sclerosis (ALS)
  • Frontotemporal Dementia
  • Parkinson Disease
  • Autoimmune conditions

 

Manufacturing

Proprietary Platform Technology and Scalable Manufacturing Process Overcomes Supply Chain Management Barriers

TAI™ (Tregs Against Inflammation) platform offers potential therapeutic approaches to address the unmet and significant medical needs of patients with ALS, Parkinson’s, Alzheimer’s, FTD and other neurodegenerative and autoimmune diseases.

     Proprietary Platform
1. Collection

Draw one-time sample from patient
2. Convert & Expand

Coya’s CTregTM platform (cryopreservation for Tregs) is the first in the industry to convert dysfunctional Tregs to functional Tregs and expand to the billions of cells

No genetic manipulation required
3. Cryopreserve

Cryopreserve Tregs for one year of monthly maintenance infusions
4. Ship, Thaw & Administer

Ship cells to outpatient infusion center

Thaw cells and provide monthly recurring infusions to patient allowing for an ‘off the shelf’ Treg cell therapy that has not been feasible to date
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Current Manufacturing Capabilities

Proprietary manufacturing process has been established to produce a highly pure, stable, and consistent Treg product covering: GMP infrastructure, automation and quality control

 

Optimized Treg expansion
  • Yields billions of highly functional Tregs
  • Short expansion time through ex-vivo process that avoids genetic manipulation

Controlled manufacturing platform geared towards commercialization
  • Cryopreserved under cGMP conditions
  • Sustainable over longer periods of time - single manufacturing round produces cells for a full year’s supply, and is conveniently stored, shipped and administered

IP protection for manufacturing including effective cryopreservation of autologous Tregs
  • Extended treatment times with successive doses
  • Functionally superior Treg products
  • Cost effective and sustainable



Robust and Reproducible Supply Chain Solution: Manufacturing and Cryopreservation

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iscEXOTM Science and Technology Overview

Orders of magnitude more potent via immunomodulation and immunosuppression than industry standard mesenchymal stem cells

The iscEXOTM Platform: Coya has developed a first-in-class exosome or extracellular vesicle (EV) product
  • Highly suppressive ex vivo expanded immunosuppressive cells (the iscEXOTM Platform)


Most Potent Anti-inflammatory Exosome Platform: derived from two of the most prominent anti-inflammatory and neuroprotective cell types- Tregs and M2 Macrophages
  • Leverage mesenchymal stem cell (MSc) derived EVs
  • EVs are not cells and avoid potential cell-based issues such as immune rejection and polarization to a pro-inflammatory cell type
whatareEVs
Unique and Differentiated Approach:
Compared to MSc Derived Exosomes, iscEXOTM is significantly more immunosuppressive

What makes our exosome
platform different?

01
Most companies leverage mesenchymal stem cell (MSC) derived exosomes, not Treg derived exosomes
02
Treg derived exosomes have an order of magnitude higher suppressive capacity and anti-inflammatory function than MSC derived exosomes required for neuroinflammatory suppression (data on file)
03
Coya has developed the only manufacturing platform to isolate highly neuroprotective Treg derived exosomes (not feasible without Coya’s primary proprietary Treg expansion process)
04
Coya has optimized cryopreservation and full functional stability of Treg exosomes 12+ months post thaw allowing for chronic off the shelf administration
05
Coya’s proprietary platform allows it to isolate, normalize and expand cells with concurrent extraction of the cellular EV contents and provides an unprecedented opportunity to shift the paradigm of EV based treatments

 

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First in Class Treg Derived Exosomes Platform Summary

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Tregs maintain tolerance to self and limit other immune responses—they achieve this through different mechanisms including the release of exosomes