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Harnessing the Power of “Super Treg” regulatory T cell therapy for the treatment of neurodegenerative diseases

We are a clinical-stage biotechnology company developing disruptive first-in-class and best-in-class approaches utilizing autologous regulatory T cells (Tregs) and Treg-derived exosome therapeutics to target disease, with an initial focus on neurodegenerative and autoimmune diseases.

Dysfunctional Tregs underlie neurodegenerative and autoimmune diseases, and we are leveraging these seminal discoveries from the laboratory of Stanley Appel M.D., to offer novel therapeutic approaches via our TAI™ platform (Tregs Against Inflammation). TAI™ involves the conversion of dysfunctional Tregs to “Super Tregs” enabling potent immunosuppressive and neuroprotective functionality and is designed to address the unmet and significant medical needs of patients with amyotrophic lateral sclerosis (ALS), Alzheimer’s, Frontotemporal Dementia (FTD) and other neurodegenerative and autoimmune diseases.

Promising Clinical and Safety Signals:

Coya is targeting multiple neurodegenerative diseases – ALS is the most advanced clinical indication having completed a successful phase 1 trial and phase 2a trial. The phase 1 trial halted disease progression in all 3 patients tested during the course of the infusions with no adverse safety events. The phase 2a trial data is promising and data is being prepared for a peer reviewed publication.

Automating manufacturing (CMC), industrializing supply chain management, and transforming patient care

Coya utilizes a proprietary 10-14 day manufacturing process that, ex-vivo, isolates millions of dysfunctional Tregs from a patient, and converts and expands these cells into billions of highly functional “Super Tregs” that are neuroprotective and immunosuppressive. This unique approach does not require genetic manipulation and has been automated into cell separation and bioreactor modules with fast vein to vein times. Finally, the technology leverages the ability to cryopreserve up to a full year’s supply of cells from one manufacturing run (via Coya’s CTreg™ (Cryopreservation for Tregs).

Our CTreg™ platform is the first in the industry to expand, freeze, and re-thaw Tregs, allowing for serial and monthly maintenance infusions while maintaining viability and suppressive function. We have also phenotypically characterized the expanded and rethawed Tregs to allow for quantification of upregulated/reproducible proteins for QC consistency from batch to batch.

EXOSOME PLATFORM

Moving beyond Tregs, we have developed the ability to isolate and expand highly neuro-protective exosomes through our iscEXO™ (immunosuppressive cell exosome) platform. FIH trials in several neurodegenerative conditions are planned in 2022 and beyond.

Coya’s Treg derived exosomes are significantly more immunosuppressive and neuroprotective than mesenchymal stem cell, platelet, and monocyte derived exosomes. Autologous and allogeneic Treg derived exosomes are in development for near term trials.

Treatment Pipeline Targets Billion Dollar Markets

Our pipeline targets the critical progenitor of the inflammatory pathway-namely Treg dysfunction, regardless of individual downstream pathways. Treg dysfunction is a hallmark in multiple neurodegenerative diseases and autoimmune conditions, providing an opportunity for our therapeutics to be tested in this patient population.

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“Patients with neurodegenerative diseases are in desperate need of transformative therapeutic options; harnessing the neuro-protective effects of Treg cell therapy shows great promise in unlocking a new treatment paradigm and will enable us to revolutionize care for patients with devastating neurodegenerative diseases.”

Dr. Stanley Appel

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