RARE Daily

Coya Completes Merger and Raises $10 Million to Advance Pipeline of Tregs for Neurodegenerative Diseases

February 4, 2021

Rare Daily Staff

Coya Therapeutics said it has concurrently completed a merger with Nicoya Health and raised $10 million in series A financing to utilize autologous regulatory T cells and allogeneic exosome therapeutics with a focus on neurodegenerative and autoimmune diseases, including amyotrophic lateral sclerosis.

Allele Capital Partners led the merger and financing, which include conversion of outstanding debt.

Amyotrophic lateral sclerosis (ALS), or Lou Gehrig’s disease, is a progressive disease that causes damage to cells in the brain and spinal cord known as motor neurons. Motor neurons transmit signals from the brain to the muscles. When motor neurons become damaged and eventually die, the brain can no longer control muscle actions. The motor neurons affected in ALS are those that initiate and control voluntary movements. With the progressive loss of voluntary muscle action, patients with ALS may lose their ability to speak, eat, move and breathe.

Proceeds from the financing will be used to advance the company’s lead therapeutic program, ALS001: an off-the-shelf, autologous, expanded autologous regulatory T (Treg) cell therapy for amyotrophic lateral sclerosis (ALS) patients. Coya will also use proceeds to introduce clinical pipeline candidates targeting Parkinson’s disease, Alzheimer’s disease, frontal temporal dementia (FTD), and other autoimmune diseases, as well as advance its non-cell based exosomes, combined therapy programs, and small molecule candidates into the clinic. Additionally, funds will be allocated to further optimize and scale manufacturing capabilities and establish best in class regulatory T cell and exosome Chemistry Manufacturing Controls (CMC) readiness.

“Patients with neurodegenerative diseases are in desperate need of transformative therapeutic options; harnessing the neuro-protective effects of Treg cell therapy shows great potential in unlocking a new treatment paradigm and may enable us to revolutionize care for patients with devastating neurodegenerative diseases,” said Stanley Appel, whose research forms the backbone of Coya’s platforms. “We have successfully demonstrated, in a phase 1 trial, the safety and tolerability of autologous infusions of expanded Tregs in ALS patients, with the potential of slowing or halting disease progression. Ongoing studies provide a transformative framework for advanced clinical trials in ALS and other neurodegenerative disorders.”

Coya Therapeutics leverages the innovations of Appel, who is co-director of Houston Methodist Neurological Institute and chair of the Stanley H. Appel Department of Neurology at Houston Methodist Hospital. Appel, one of the nation’s foremost experts on ALS treatment advances, documented the intimate relationship of neurodegeneration and ALS progression with dysfunctional and decreased levels of Tregs driving the disease process, and the ability to isolate, “repair,” and expand these Tregs outside the body for reinfusion to the patient, which is the basis for Coya’s proprietary and patented TAI (Tregs Against Inflammation) platform. The TAI platform offers therapeutic approaches to address the unmet and significant medical needs of patients with ALS, Parkinson’s, Alzheimer’s, FTD and other autoimmune diseases.

Coya’s second platform, CTreg (Cryopreservation for Tregs), is the first in the industry to expand, freeze, and re-thaw Tregs, while maintaining viability and suppressive function, thus solving manufacturing and supply-chain limitations and providing an ‘off the shelf’ Treg cell therapy that enables serial and monthly infusions.

“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,” said Howard Berman, CEO of Coya Therapeutics. “The ability to manufacture and cryopreserve a 12-month supply of a patient’s cells from one manufacturing run overcomes prior limitations and revolutionizes supply chain management, allowing for maintenance monthly infusions. Through our sponsored research program in conjunction with Dr. Appel, we look forward to continuing advancement of this promising work and translating this work into a meaningful therapy for patients.”

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