Science & Technology

We are Pioneering the Research and Development of New Therapies to Enhance the Function of Regulatory T Cells (Tregs)

Dr. Shimon Sakaguchi, a member of our Scientific Advisory Board, discovered Tregs in 1995.

Dr. Stanley Appel, the Chair of our Scientific Advisory Board, and the research team at Houston Methodist Hospital leveraged this discovery by developing transformative therapies enhancing the immunomodulatory function of Tregs.

Tregs and How They Function

Tregs are a type of lymphocyte that modulate the body’s immune response.

The main functions of Tregs are:

Cells

Anti-inflammatory
Healthy Treg Cells

Pro-inflammatory Cells
and Cytokines

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  • Th17 Cells
  • Macrophages
  • NK Cells
  • B Cells
  • Effector T cells
Healthy Tregs

Tregs are important anti-inflammatory immune cells involved in homeostasis. Tregs act on multiple immune cells to down-regulate the release of pro-inflammatory cytokines.

health

Dysfunctional Tregs and Reduced Healthy Tregs

red

Pro-inflammatory Cells
and Cytokines

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  • Th17 Cells
  • Macrophages
  • NK Cells
  • B Cells
  • Effector T cells
Dysfunctional Tregs

When Tregs become dysfunctional, a cytokine-mediated inflammatory state can arise leading to neurodegenerative, autoimmune, and metabolic diseases.

COYA 301: Treg-Enhancing Biologic Therapy to Reduce Inflammation

Baseline Inflammatory Environment

COYA 301 plays a key role in the development, expansion, activity, and survival of Tregs

COYA 301 will be supplied in a pre-filled syringe for subcutaneous injection.
COYA 301 is an investigational product candidate not yet approved by the US Food and Drug Administration.

COYA 302: Combination of Two Biologics with a Dual Mechanism of Action

Synergistic enhancement of Treg function and depletion of effector T cells and macrophages to further decrease inflammation.

COYA 302 is an investigational product candidate not yet approved by the US Food and Drug Administration.

COYA 200 Series:
First in Class Treg Exosomes

Exosomes derived from Tregs, one of the most prominent anti-inflammatory and neuroprotective cell types.

COYA 201 is an investigational product candidate not yet approved by the US Food and Drug Administration.

Tethering Exosomes to Enhance Targeting

Coya Therapeutics has licensed a proprietary platform for exosome polymer hybrids that allows the exosome to target proteins of interest while delivering drugs and/or cargo.

COYA 206 is an investigational product candidate not yet approved by the US Food and Drug Administration.

COYA 101: Autologous Treg Cell Therapy for the Treatment of ALS

Expanded suppressive Tregs reduce neuroinflammation.

Baseline Tregs
from Patients
Billions of Cryopreserved Highly Suppressive Tregs
Completed
Clinical Trials
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Phase 1 First-in-Human Study​
  • Established preliminary safety and viability of manufacturing process​
  • Phase 1 paper published (May 2018)​
  • Phase 1 biomarker paper published (April 2022)​

Phase 2a Study​

  • Validated Phase 1 results showed evidence of adequate safety
  • In open label portion of trial, 6 out of 8 patients (75%) slowed or stopped progression
  • Improved manufacturing process with bioreactor expansion
  • Phase 2a paper published (September 2022)

Received Orphan Drug Designation ​

Ex Vivo Expansion
& Conversion

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  • A single manufacturing run from one patient’s blood sample produces sufficient expanded and converted Tregs to provide up to 12 months of treatment
  • No genetic manipulation of cells required
  • Intravenous administration in an out-patient facility

Cryopreservation &
Long-term Stability

+
Phase 1 First-in-Human Study​
  • Established preliminary safety and viability of manufacturing process​
  • Phase 1 paper published (May 2018)​
  • Phase 1 biomarker paper published (April 2022)​

Phase 2a Study​

  • Validated Phase 1 results showed evidence of adequate safety
  • In open label portion of trial, 6 out of 8 patients (75%) slowed or stopped progression
  • Improved manufacturing process with bioreactor expansion
  • Phase 2a paper published (September 2022)

Received Orphan Drug Designation ​

+
  • A single manufacturing run from one patient’s blood sample produces sufficient expanded and converted Tregs to provide up to 12 months of treatment
  • No genetic manipulation of cells required
  • Intravenous administration in an out-patient facility

COYA 101 is an investigational product candidate not yet approved by the US Food and Drug Administration.