COYA 301 / Coya Therap, ARScience Bio - LARVOL DELTA

Upcoming Expected Catalysts (Businesswire) - "First patient enrolled in COYA 302 ALSTARS Trial; First patient dosed in COYA 302 ALSTARS Trial; Upon first patient dosing of COYA 302 in ALS, expect to receive $4.2 million milestone payment from strategic partner, Dr. Reddy’s Laboratories (DRL)...ALS Biomarker data. Publication of longitudinal data on Neurofilament Light Chain (NfL) and oxidative stress markers in patients with ALS; Report additional single cell proteomics data from the completed investigator-initiated, 21-week, double-blind, placebo-controlled, exploratory Phase 2 study of low-dose interleukin-2 (LD IL-2) in patients with Alzheimer’s disease (AD); Top-line clinical data release for an investigator-initiated trial combining LD IL-2 + CTLA4-Ig in patients with FTD; IND submission for FTD anticipated in Q4 2025."

Clinical data • Financing • IND • Trial status • Amyotrophic Lateral Sclerosis • Frontotemporal Lobar Degeneration

Upcoming Expected Catalysts for 2025 (PRNewswire) - "ALS Biomarker data. Publication of longitudinal data on Neurofilament Light Chain (NfL) and oxidative stress markers in tracking progression and survival in patients with ALS; Report new proteomics data from the completed investigator-initiated, 21-week, double-blind, placebo-controlled, exploratory Phase 2 study of low-dose interleukin-2 (LD IL-2) in patients with Alzheimer's disease (AD); Top-line clinical data release for an investigator-initiated trial combining LD IL-2 + CTLA4-Ig in patients with Frontotemporal Dementia (FTD); Top-line data for COYA 303 in an in-vivo inflammatory animal model."

Clinical data • Preclinical • Alzheimer's Disease • Frontotemporal Lobar Degeneration

Coya Therapeutics Reports Statistically Significant Improvement of Inflammatory Blood Markers in Patients with Alzheimer’s Disease Following Monthly Dosing with Low-Dose IL-2, Further Supporting Clinical Development (Businesswire) - P2 | N=40 | NCT06096090 | "Statistically significant reduced levels of proinflammatory markers were observed in patients receiving a five-day treatment of subcutaneous LD IL-2 on a monthly cycle in comparison to a biweekly 5-day administration or placebo. Lower blood levels of the proinflammatory chemokine (C-C motif) ligand 2 (CCL2) (p<0.05) and proinflammatory cytokine IL-15 (p <0.001) were statistically significant, and a statistically significant increase in the anti-inflammatory cytokine IL-4 (p<0.01) in patients receiving monthly cycles of LD IL-2 was observed, compared to patients receiving placebo. At the end of the five-month treatment period when treatment was removed, the anti-inflammatory benefits reverted back to placebo levels...Coya plans to publish and present the results of this study throughout 2025."

P2 data • Alzheimer's Disease

Coya Therapeutics Announces Pipeline Expansion - COYA 303: COYA 301 in Combination with GLP-1 Receptor Agonist for the Treatment of Inflammatory Diseases (Businesswire) - "Coya Therapeutics...announces the expansion of its investigational pipeline and advancement of COYA 303 for the treatment of inflammatory diseases. Sustained inflammatory responses driven by dysfunctional immune regulation is a hallmark of serious autoimmune and neurodegenerative diseases...In a preclinical study, COYA 303 exhibited a dual immunomodulatory mechanism of action resulting in an additive/synergistic anti-inflammatory effect, which the Company believes was due to increased Treg function and suppressed pro-inflammatory myeloid cells and responder T cells. Coya intends to publish the results of this study in a peer-reviewed publication in the first half of 2025 and has filed several patent applications to protect the compound....Following the positive results of this study, Coya intends to continue ongoing strategic discussions to advance COYA 303 through IND-enabling studies and into the clinic."

Pipeline update • Preclinical • CNS Disorders • Immunology • Inflammation

Coya Therapeutics Provides a Corporate Update and Reports Unaudited Third Quarter 2024 Financial Results (Businesswire) - "Q1 2025: Additional clinical data to be released in the Phase 2 LD IL-2 investigator-initiated trial (IIT) study in patients with AD...Q1/Q2 2025: COYA 301/GLP-1 combination data submission for publication and additional intellectual property filings...Q2 2025: ALS Biomarker data. Publication of longitudinal data on Neurofilament Light Chain (NfL) and oxidative stress markers in patients with ALS."

Biomarker • Clinical • P2 data • Alzheimer's Disease • Amyotrophic Lateral Sclerosis • CNS Disorders

Coya Therapeutics Announces Conference Call to Report Results from an Investigator-Initiated Phase 2 Trial of Low-Dose Interleukin-2 in Patients with Mild to Moderate Alzheimer’s Disease (Businesswire) - "Coya Therapeutics, Inc...announces it will conduct a conference call on Tuesday, October 29, at 8am ET to discuss results from a placebo-controlled, investigator-initiated Phase 2 clinical trial of low-dose interleukin-2 (LD IL-2) in patients with mild to moderate Alzheimer's Disease (AD). These clinical results will be presented simultaneously via a poster on Tuesday, October 29, at the 17th Clinical Trials on Alzheimer’s Disease Conference (CTAD24) in Madrid, Spain."

P2 data • Alzheimer's Disease • CNS Disorders

Coya Therapeutics Announces Positive Results of a Double-Blind Study of Subcutaneous Low-Dose Interleukin-2 (LD IL-2) in Alzheimer’s Disease (AD) Presented at the Clinical Trials on Alzheimer’s Disease Conference (CTAD24) in Madrid (Spain) (Businesswire) - P2 | N=40 | NCT06096090 | "...LD IL-2 showed targeted biological activity, evidenced by a significant expansion of regulatory T cell populations in the LD IL-2 q4wks group without any off-target effects on other peripheral lymphocytes; All patients completed the 21-week treatment phase. The proportion of patients experiencing adverse events (AEs) was similar between the LD IL-2 treatment groups and the placebo group, with no serious AEs or deaths reported; There was a significant increase (p < 0.05) in the percentage of CD4+ FOXP3+CD25 high Tregs, mean fluorescence intensity (MFI) of Foxp3, Treg CD25 MFI, and Treg suppression of T responders following both dosing regimens of LD IL-2 treatment compared to placebo.'

P2 data • Alzheimer's Disease

Coya Therapeutics Expands Pipeline and Intellectual Property Portfolio with Filing of New U.S. Patents for COYA 301 in Combination with Glucagon-Like Peptide-1 (GLP-1) Receptor Agonists (Businesswire) - "Data supporting these patents indicate that COYA 301 and GLP-1 RA combinations may have an additive and/or synergistic anti-inflammatory effect on multiple cell types, including enhancement of regulatory T cell function, suppression of pro-inflammatory myeloid and T cells, and repolarization of these cells to anti-inflammatory phenotypes...Coya Therapeutics, Inc...announces the filing of intellectual property protection for the combination of COYA 301, or recombinant human low dose interleukin-2 (LD IL-2), and Glucagon-Like Peptide-1 receptor agonists (GLP-1 RAs)."

Patent • Immunology

Coya Therapeutics faces FDA hold on ALS drug study (Investing.com) - "In addition, Coya has completed a Phase 2 trial investigating LD IL-2 for mild-to-moderate Alzheimer's disease, with top-line results expected in the summer of 2024...The company has also secured a $5 million investment from the Alzheimer's Drug Discovery (NASDAQ:WBD) Foundation (ADDF) for the development of its lead therapeutic candidate, COYA 302, designed to treat Frontotemporal Dementia."

Financing • P2 data • Alzheimer's Disease • CNS Disorders • Dementia

Coya Therapeutics Expands Sponsored Research Collaboration with Houston Methodist Research Institute Along with Funding from the Johnson Center for Cellular Therapeutics to Advance Regulatory T Cell Exosome Platform into the Clinic (Businesswire) - "Coya Therapeutics...announces the expansion of its research collaboration with the Houston Methodist Research Institute...through a sponsored research agreement (SRA) covering multiple initiatives...Coya and HMRI will advance the development of multiple patented modalities of exosomes, including full characterization of the nanovesicles, and GMP manufacturing to enable a first-in-human academic clinical study. Furthermore, Coya will continue the characterization and validation of several clinical biomarkers in patients with Amyotrophic Lateral Sclerosis, Alzheimer’s Disease, Frontotemporal Dementia, and Parkinson’s Disease....In addition, Coya and HMRI will continue exploring the potential synergy of COYA 301 (LD IL-2) with other relevant drug products, following the innovative approach of COYA 302 (LD IL-2 + CTLA4-Ig) targeting multiple paths involved in the pathophysiology of severe neurodegenerative and autoimmune diseases."

Licensing / partnership • Alzheimer's Disease • Amyotrophic Lateral Sclerosis • CNS Disorders • Dementia • Frontotemporal Lobar Degeneration • Immunology • Parkinson's Disease

Coya Therapeutics Licenses Intellectual Property Rights for Use of Next Generation Immune Modulatory Biologics in Combination with COYA 301 to Enhance Regulatory T Cells (Tregs) in Inflammatory Diseases (Businesswire) - "Coya Therapeutics, Inc...has expanded and strengthened its patent estate beyond COYA 302, which is a combination of COYA 301 with CTLA-4 Ig. This license with UNeMed Corporation (UNeMed), the Technology Transfer Office of University of Nebraska Medical Center, covers the combination of COYA 301 with GM-CSF and additional immune analogues and provides a next generation approach with a novel combination to synergistically modulate and reduce inflammation. UNeMed will receive payments upon achievement of certain milestones and will be eligible to receive tiered low single-digit royalty on net sales."

Licensing / partnership • Alzheimer's Disease • CNS Disorders • Parkinson's Disease

Coya Therapeutics Announces Pipeline Expansion of COYA 302 to Include Frontotemporal Dementia and Parkinson’s Disease in Addition to Amyotrophic Lateral Sclerosis (Businesswire) - "H2 2024: COYA 302 First patient dosed in Phase 2 Trial in ALS Patients; COYA 302 File IND and Initiate Phase 2 Trial in FTD Patients; COYA 302 Animal data released in PD model; COYA 301 Proof of Concept combination data with Drug X in AD mouse model; COYA 301 Phase 2 Investigator Initiated Trial Topline AD data Presented (Summer)..."

IND • New P2 trial • Preclinical • Alzheimer's Disease • Amyotrophic Lateral Sclerosis • CNS Disorders • Immunology • Parkinson's Disease

Coya Therapeutics Announces Pipeline Expansion of COYA 302 to Include Frontotemporal Dementia and Parkinson’s Disease in Addition to Amyotrophic Lateral Sclerosis (Businesswire) - "Coya Therapeutics, Inc...announces that it is expanding its pipeline in neurodegenerative conditions for COYA 302 beyond ALS to include frontotemporal dementia (FTD) and Parkinson’s disease (PD). The Company’s updated pipeline can be viewed here....H1 2024: COYA 302 File IND and Initiate Phase 2 Trial in ALS Patients; COYA 302 Publication of Phase 1 Investigator Initiated Trial clinical data in ALS Patients; COYA 302 Publication of Longitudinal Biomarker study with correlation to patient survival in ALS Patients; COYA 302 Presentation on Longitudinal Biomarker Data in ALS Patients at Conference; COYA 301 Presentation of Phase 1 Investigator Initiated Trial data in AD Patients at 18th annual AD + PD Conference..."

Biomarker • IND • New P2 trial • P1 data • Pipeline update • Alzheimer's Disease • Amyotrophic Lateral Sclerosis • CNS Disorders • Parkinson's Disease

A phase 1 open-label pilot study of low-dose interleukine-2 immunotherapy in patients with Alzheimer's disease. (PubMed, Transl Neurodegener) - P1 | "ClinicalTrials.gov Identifier: NCT05821153, Registered April 20 2023, Retrospectively registered, https://classic. gov/ct2/show/NCT05821153."

Journal • P1 data • Alzheimer's Disease • CNS Disorders

Coya Therapeutics, Inc. Provides Business Update and Reports Q3 2023 Unaudited Financial Results (Businesswire) - "COYA 302 (ld IL-2 + CTLA4 Ig): Phase 2 IND Filing in ALS (1H 2024); Initiate Phase 2 trial in ALS (following IND Filing); Proof of Concept Phase 1 investigator-initiated clinical study publication (Q1 2024); Biomarker data and ALS registry publication (Q1 2024); COYA 301 (ld IL-2): Topline data of academic investigator Initiated Phase 2 double blind trial in Alzheimer’s Disease (Summer 2024); Proof of Concept investigator-initiated Phase 1 clinical study publication in Alzheimer’s Disease (Q4 2023 or Q1 2024); Phase 1 proof of concept investigator-initiated clinical study in Alzheimer’s Disease presentation at 18th annual Alzheimer’s and Parkinson’s Disease Conference (Q1 2024); Combination LD IL-2 + Undisclosed Drug AD animal data release (2H 2024)..."

Biomarker • IND • P1 data • P2 data • Alzheimer's Disease • Amyotrophic Lateral Sclerosis • CNS Disorders

Coya Announces Acceptance of Oral Presentation, “Regulatory T Cell Expansion Strategy to Target Inflammation in Alzheimer’s Disease: A Phase 1 Feasibility Study,” at the 18th International Conference on Alzheimer’s and Parkinson’s Disease in Lisbon (Businesswire) - "Coya Therapeutics, Inc...today announced that Dr. Alireza Faridar, Assistant Professor of Neurology at Houston Methodist and Weill Cornell Medical College, will give an oral presentation at the 18th International Conference on Alzheimer’s and Parkinson’s Disease held in Lisbon, Portugal between March 5-9, 2024....Dr. Faridar and team are currently conducting a double-blind, randomized, well-controlled study in 38 AD patients evaluating the safety and tolerability, biological activity, blood and cerebrospinal fluid biomarkers, neuroimaging, and changes in cognitive function of LD IL-2 compared to placebo at pre-specified timepoints over the course of a 21-week treatment period and at 9 weeks after the last dose of study treatment. Topline results of this study are anticipated to be reported in the first half of 2024. The study is funded by the Gates Foundation and the Alzheimer’s Association."

P1 data • Alzheimer's Disease • CNS Disorders

Coya Therapeutics (Coya) Announces Completion of Enrollment in a Well-Controlled Phase 2 Study of Low Dose Interleukin-2 (LD IL-2) in Patients with Alzheimer’s Disease (AD) (Businesswire) - "Coya Therapeutics, Inc...today announced completion of enrollment in a randomized, double-blind, placebo-controlled phase 2 study of LD IL-2 in patients with mild-to-moderate AD. The study is being conducted by Drs. Stanley Appel and Alireza Faridar at the Houston Methodist Hospital. A total of 38 patients were randomly assigned to receive subcutaneous LD IL-2 at two different dosing regimens, or matching placebo, over 21 weeks. The first patient cohort was randomized to receive LD IL-2 for 5 consecutive days every 4 weeks and the second cohort was randomized to receive LD IL-2 for 5 consecutive days every 2 weeks....Topline results of the study are anticipated to be reported in Summer 2024. The study is funded by the Gates Foundation and the Alzheimer’s Association."

Enrollment closed • P2 data • Alzheimer's Disease • CNS Disorders

Coya Therapeutics Announces Publication of Potential Novel Blood Biomarker Data in Amyotrophic Lateral Sclerosis (ALS) Patients That Accurately Reflect Therapeutic Responses When Treated with Regulatory T Cell (Treg) Enhancing Therapies (Businesswire) - P2 | N=12 | NCT04055623 | P1 | N=4 | NCT03241784 | Coya Therapeutics, Inc...today reported the publication of a research article...in the peer-reviewed journal Ageing and Neurodegenerative Diseases....The publication reports the analyses of blood biomarker data from a cross sectional cohort of sporadic ALS patients (n = 30) and healthy controls (n=10) and from two investigator-initiated clinical studies (IIT) (n=11). In the IIT studies, patients were treated with expanded Treg cell therapy in combination with low-dose interleukin-2 (IL-2). As previously reported, patients from these two trials experienced amelioration of disease progression with corresponding increased Treg numbers and suppressive function. Evidence strongly supports the role of inflammation and oxidative stress in the severity and rate of disease progression in ALS."

Biomarker • P1 data • P2 data • Amyotrophic Lateral Sclerosis • CNS Disorders

Coya Therapeutics Reports Additional Proof-of-Concept Clinical Biomarker Data in Patients with Alzheimer’s Disease (Businesswire) - P1 | N=8 | NCT05821153 | "Coya Therapeutics, Inc...today reported results from an open-label proof-of-concept clinical study for ld IL-2 in patients with AD. Results of the study were presented July 16, 2023, at the Alzheimer’s Association International Conference (AAIC) in Amsterdam, Netherlands....The additional blood biomarker data showing a significant decrease in the blood levels of the proinflammatory cytokines and chemokines CCL4, FLT3LG and TNFα in AD patients treated with ld IL-2 strengthen the positive results Coya has previously announced in May 2023....In addition, evaluation of cognitive function showed that administration of ld IL-2 resulted in a statistically significant improvement in mean MMSE scores during the treatment phase, compared to mean MMSE score at baseline (p=0.015). Consistent with the positive trend in MMSE score, mean scores in ADAS-Cog and CDR-SB scales did not significantly change at the end of treatment with COYA 301..."

P1 data • Alzheimer's Disease • CNS Disorders • Tauopathies And Synucleinopathies

Coya Therapeutics to Present Proof-of-Concept Clinical Data for Low-Dose Interleukin-2 (ld IL-2) for the Treatment of Patients with Alzheimer’s Disease (AD) at the 2023 Alzheimer’s Association International Conference (AAIC) (Businesswire) - "Coya Therapeutics...today announced the presentation of results from an academic clinical study in patients with Alzheimer’s Disease (AD) with subcutaneous ld IL-2 at the 2023 Alzheimer’s Association International Conference (AAIC) to be held in Amsterdam, Netherlands, from July 16-20, 2023."

P1 data • Alzheimer's Disease • CNS Disorders

Coya Therapeutics, Inc. (Coya) Broadens its COYA 300 Biologics Patent Estate for the Exclusive Patent Rights and Know-how in treatment of Parkinson's Disease (PD) (Businesswire) - "Coya Therapeutics, Inc...today announced expansion of its patent estate for COYA 301....UNeMed will receive payments upon achievement of certain milestones and will also be eligible to receive tiered low-single digit royalty on net sales....The preclinical model published by University of Nebraska Medical Center scientists demonstrated that treatment with ld IL-2 induced a treatment-specific Treg population with overexpression of immunosuppressive Treg cell markers. Furthermore, the treatment had a potent neuroprotective effect on nigral dopaminergic neurons in affected mice. The degeneration of nigral dopaminergic neurons is considered the hallmark of PD suggesting that this interventional strategy may lead to sustained suppressive immune responses and neuroprotection in PD."

Licensing / partnership • Preclinical • CNS Disorders • Immunology • Parkinson's Disease

Coya Therapeutics Reports Additional Blood Biomarker and Brain Imaging Data Showing Decrease in Neuroinflammation Following Treatment with COYA 301 in Alzheimer’s Disease (AD) (Businesswire) - "Coya reports new data illustrating that administration of COYA 301 (low dose Interleukin-2 (IL-2)) in an open- label study in 8 patients with mild to moderate AD (COYA 301 Trial) resulted in a statistically significant reduction in the expression of three well characterized proinflammatory cytokines -- Tumor Necrosis Factor alpha (TNF-α), Interleukin 6 (IL-6), and Interleukin 1- Beta (IL-1β) -- which correlated with lack of cognitive decline of the patients over the course of the study....In addition to COYA 301 administration resulting in a statistically significant reduction of blood biomarkers CCL11, CCL2, and IL-15. Today, we report statistically significant reductions in the peripheral expression of the pro-inflammatory cytokines TNF-α, IL-6, and IL-1β. These biomarkers are well characterized in playing a central role in AD pathophysiology, propagation of neuroinflammation, and contribution to neuronal damage."

Biomarker • Clinical data • Alzheimer's Disease • CNS Disorders

Coya to Present Additional Biomarker and Brain Imaging Data for COYA 301 in Alzheimer’s Disease (AD) at the LD Micro Conference on June 7, 2023 (Businesswire) - "Coya previously announced results from an open-label study of COYA 301 in 8 patients with Alzheimer’s disease (AD) that resulted in a statistically significant improvement in cognitive function, as measured by the Mini-Mental State Examination test (MMSE).Coya to present on additional blood biomarker data for pro- inflammatory cytokines Tumor Necrosis Factor alpha (TNF-α), Interleukin 6 (IL-6), and Interleukin 1- Beta (IL-1β) from the recently presented 8 patient investigator-initiated AD study. ncreased systemic levels of TNF-α, IL-6, and IL-1β have been associated with cognitive decline and may play a role in the pathogenesis and pathophysiology of AD. Coya also to provide a case report documenting pre- and post-treatment Positron Emission Technology (PET) imaging illustrating the impact of COYA 301 treatment on brain inflammation in one patient that showed cognitive improvement."

Biomarker • Clinical data • Alzheimer's Disease • CNS Disorders

Coya Therapeutics’ COYA 301 Increased Treg Function and Halted Cognitive Decline in an Open Label Study in Patients with Alzheimer’s Disease (Businesswire) - "Coya Therapeutics...today reported results from an open-label proof-of-concept clinical study for COYA 301 in patients with AD. Results of the study will be presented on May 16, 2023, at the Keystone Conference ‘Neurodegeneration: New Biology Guiding the Next Generation of Therapeutic Development’ in Whistler, B.C. Canada. The study enrolled 8 patients with confirmed presence of brain amyloid pathology and baseline MMSE scores between 12 and 25. The patients were treated with five-day-courses of COYA 301 for four monthly cycles and were followed for two months post-treatment....COYA 301 administration significantly expanded Treg population and function. At baseline, the mean (SD) percentage of Tregs was 4.55 (1.97) and was almost double at the end of the treatment [8.68 (2.99), p=0.0004]. Mean (SD) Treg suppressive function was 46.61% (7.74) at baseline, and significantly increased to 79.5 % (20.55) at the end of treatment (p=0.003). In addition, COYA..."

Clinical data • Alzheimer's Disease • CNS Disorders • Dementia

Coya Therapeutics, Inc. Provides Business Update and Reports FY 2022 Unaudited Financial Results (Businesswire) - "Coya Therapeutics...COYA 301 for FTD: IND filing and initiate Phase 1 (H2 2023); interim Data (H2 2023)....COYA 302 for neurodegenerative diseases: file IND and initiate Phase 1 (H2 2023)....COYA 201 for neurodegenerative, autoimmune, and metabolic diseases: Completion of Therapeutic Animal Model Studies (1H 2023)....COYA 101 for ALS: Initiate Phase 2b with grant funding or collaborative partnership (2024)."

Licensing / partnership • New P1 trial • New P2b trial • Alzheimer's Disease • Amyotrophic Lateral Sclerosis