Regulatory T cell (Treg) Dysfunction is at the nexus of neurodegenerative and autoimmune disease pathophysiology and through a proprietary manufacturing process, Coya has perfected the ability in producing highly functional Tregs as well as Treg derived exosomes
Coya Therapeutics has developed a transformative ex-vivo (outside the body) platform to transform and expand billions of highly functional Tregs from millions of dysfunctional Tregs removed from a diseased patient. In addition, from the same manufacturing run, billions of highly immunosuppressive Treg derived exosomes (extracellular vesicles) are also captured for therapeutic use.
Dysfunctional and decreased levels of Tregs underlie multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis (ALS). Coya has pioneered the ability to isolate dysfunctional Tregs from a patient, convert them to a highly functional and neuroprotective condition, and expand these cells into the billions for intravenous reinfusion back to the patient. The ability to manufacture and cryopreserve a 12 month patient’s supply of cells from one manufacturing run (via its patent pending CTregTM - Cryopreservation for Tregs platform) overcomes prior limitations and revolutionizes supply chain management, allowing for maintenance monthly infusions.
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 currently in the midst of a larger 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 will be available mid-2021.
TARGETING MULTIPLE DISEASES
Other conditions under evaluation (and which dysfunctional Tregs underlie disease decline) include Frontotemporal Dementia, Parkinson’s Disease, Alzheimer’s Disease, Multiple Sclerosis, and specific Autoimmune Conditions.
Coya has also developed the ability to isolate and expand highly neuroprotective exosomes (through its patent pending EAITM- Exosome Against Inflammation platform) and plans FIH trials in a number of neurodegenerative conditions, beginning end of 2021 and/or 2022.
“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.”