Coya Therapeutics, Inc. · NASDAQ:COYA
Coya Therapeutics — 2023 MDA Clinical & Scientific Conference
18 slides from Coya Therapeutics's conference presentation, Mar 21, 2023
Slide 1: Novel Treg-modulating Immunotherapy Targets Inflammation in ALS
Stanley H. Appel, MD Jason Thonhoff, MD, PhD David Beers, PhD Houston Methodist Research Institute 2023 MDA Clinical & Scientific Conference Novel Treg-modulating Immunotherapy Targets Inflammation in ALS Exhibit 99.1
Slide 2: Disclosures
Disclosures Mitsubishi Tanabe Pharma – Member of Clinical Advisory Board; Eledon Pharmaceuticals - Consultant; Implicit Bioscience - Consultant; Coya Therapeutics - Chair of Scientific Advisory Board
Slide 3: Disclosures
Disclosures The Houston Methodist Hospital has entered into an exclusive license agreement with Coya Therapeutics, Inc. for the know-how and patents related to its investigational product COYA 302 (IL-2/CTLA4-Ig). The development of this technology and the clinical study has been funded in part by C
Slide 4: Neuroinflammation - Propagating Neuronal Injury in Amyotrophic Lateral Sclerosis
- Neuroinflammation - Propagating Neuronal Injury in Amyotrophic Lateral Sclerosis
Slide 5: Systemic Immune Alterations Promote Inflammation in ALS
Blood monocytes/macrophages and CNS microglia are proinflammatory. Th1 and Th17 lymphocytes are activated and proinflammatory Neuroprotective FoxP3 regulatory T lymphocytes are decreased and dysfunctional. Systemic Immune Alterations Promote Inflammation in ALS Augmenting Burden of Disease and Rates
Slide 6: Activated Macrophages Promote Dysfunction of Treg Numbers and Suppressive Functions
Activated Macrophage Regulatory T Cell FoxP3 x Activated Th1-Th17 IL-1β NO, O2- IL-18 4-HNE IL-6 H2O2 TNFa Activated Macrophages Promote Dysfunction of Treg Numbers + Suppressive Functions Releasing Proinflammatory Cytokines and Markers of Oxidative Stress Proinflammatory cytokines and oxidative str
Slide 7: In vivo expansion of Tregs in ALS
In vivo expansion of Tregs in ALS In vivo Treg expansion strategy with IL-2/CTLA4-Ig was applied for 48 weeks Four ALS patients were enrolled Changes in Treg Suppressive function, Treg numbers, ALSFRS, and biomarkers of lipid peroxides and proinflammatory cytokines were monitored 30-40% 80-90%
Slide 8: Lipid Peroxide Biomarkers of Inflammation in ALS
Lipid Peroxide Biomarkers of Inflammation in ALS * p<0.05 ** p<0.01 n.s.: not significant ** * * ** n.s. ** ** 4-Hydroxynonenal (4-HNE) Oxidized Low-Density Lipoprotein (ox-LDL)
Slide 9: Expanded Treg Combination Therapy for ALS - IL-2/CTLA4-Ig
Expanded Treg Combination Therapy for ALS - IL-2/CTLA4-Ig Th1,Th17 80-90% IL-1β NO, O2- IL-18 4-HNE IL-6 H2O2 TNFa CTLA4Ig Proinflammatory Macrophages 30-40% CD80 FoxP3 FoxP3 FoxP3 FoxP3 IL-2
Slide 10: Proof-of-Concept Clinical Study
Proof-of-Concept Clinical Study Open-label, single-arm in 4 patients with ALS IL-2/CTL4-Ig was administered via subcutaneous injection over 48 weeks
Slide 11: Patients' Demographics and Baseline Characteristics
Patients’ Demographics and Baseline Characteristics Age (years) Sex Type Onset ALS Progression Prior to Baseline (ALSFRS-R score) Respiratory Status Respiratory Support Patient 1 47 Female Familial Limb -1.6 points / month No Respiratory Insufficiency None Patient 2 54 Male Sporadic Limb -1 points /
Slide 12: IL-2 and CTLA4-Ig significantly increased Treg suppressive function in vivo
IL-2 and CTLA4-Ig significantly increased Treg suppressive function in vivo Treatment Period Follow-Up IL-2 and CTLA4-Ig significantly upregulates Treg suppressive function as early as 4 weeks after initiation of treatment and maintained a significantly increased Treg function over the course of tre
Slide 13: IL-2/CTL4-Ig Significantly Increased Treg Numbers in vivo
IL-2/CTL4-Ig Significantly Increased Treg Numbers in vivo Consistent with the significant increase in Treg function, IL-2 and CTLA4-Ig increased Treg numbers as early as 4 weeks after initiation of treatment and maintained a higher number over the course of treatment. ** * n.s. n.s. * p<0.05 ** p <0
Slide 14: IL-2/CTLA-Ig - Lipid Peroxide Biomarkers (interim data)
IL-2/CTLA-Ig - Lipid Peroxide Biomarkers (interim data) * n.s. * p<0.05 n.s.: not significant (paired t test)
Slide 15: IL-2/CTLA4-Ig - Biomarkers by Patient (interim data)
IL-2/CTLA4-Ig - Biomarkers by Patient (interim data)
Slide 16: ALSFRS-R scores over 48-week treatment
The mean ALSFRS-R scores at 24 and 48 weeks after initiation of treatment were not statistically different, compared to the baseline score n.s. 48-Week Treatment Follow-Up B: baseline n.s.: not significant (paired t test) IL-2 and CTLA4-Ig appeared to ameliorate disease progression over the course o
Slide 17: Safety Summary
Safety Summary Overall, treatment with IL-2 and CTL4-Ig was well tolerated over 48 weeks. Most common adverse event was mild injection site reaction. All patients completed the study. No death or other serious adverse event occurred over the course of the study.
Slide 18: Conclusions: Biomarkers and Therapeutic Targets in ALS
Conclusions: Biomarkers and Therapeutic Targets in ALS In ALS Treg’s normal neuroprotective functions are impaired and macrophages/microglia are proinflammatory. Macrophage/myeloid–mediated inflammatory cytokines, oxidative stress, and lipid peroxides are increased promoting neuronal injury and cell
Coya Therapeutics — 2023 MDA Clinical & Scientific Conference on 6ix