Coya Therapeutics Presents ALS Biomarker Data at Society of Neuroimmune Pharmacology Conference - Seite 2

Summary of Study Results

Data was collected from a previously established biobank at Houston Methodist to monitor and track ALS patient outcomes with biomarkers. Serial longitudinal sampling of serum was assessed in 50 patients over the duration of their journeys from diagnosis to death. 4-HNE was identified in previous studies as a biomarker of interest relevant to ALS pathophysiology. Thus, serum 4-HNE levels were tracked and monitored during the patients’ treatment journeys, while healthy patients were measured as controls. Results demonstrate that:

• 4-HNE serum levels are significantly elevated in ALS patients compared to healthy controls
• 4-HNE serum levels correlate with the rate of disease progression in ALS patients (ALSFRS points/month) - The higher the 4-HNE serum level, the faster the progression
• 4-HNE serum levels correlate with survival from onset and diagnosis to death -The higher the 4-HNE serum level, the shorter the survival
• A receiver operating characteristic curve (ROC) analysis documents a 91.7% sensitivity and 71.1% specificity in predicting 24-month survival based on a threshold 4-HNE level of 8 ug/ml: If 4-HNE serum levels are > 8 ug/ml, there is a 91.7% chance that patient survival will be less than or equal to 24 months. If 4-HNE serum level is < 8 ug/ml, there is a 71.1% chance that patient survival is greater than 24 months
• Based on a proof-of-concept study, COYA 302 (combination of LD IL-2 and CTLA-4 Ig) may lower 4-HNE levels and levels of other relevant biomarkers that correlate with disease progression.

About COYA 302

COYA 302 is an investigational and proprietary biologic combination therapy with a dual immunomodulatory mechanism of action intended to enhance the anti-inflammatory function of regulatory T cells (Tregs) and suppress the inflammation produced by activated monocytes and macrophages. COYA 302 is comprised of proprietary low dose interleukin-2 (LD IL-2) and CTLA-4 Ig (abatacept) and is being developed for subcutaneous administration for the treatment of patients with ALS, Frontotemporal Dementia (FTD), Parkinson’s Disease (PD), and Alzheimer’s Disease (AD). These mechanisms may have additive or synergistic effects.