COYA 302 / Coya Therap, Houston Methodist Hospital, Dr. Reddy’s - LARVOL DELTA

Coya Therapeutics Announces Issuance of New U.S. Patent Protecting Methods of Producing Recombinant Human (rh) Interleukin-2 (aldesleukin) Liquid Formulations (Coya Press Release) - "Coya Therapeutics, Inc...announced the issuance of a U.S. patent relevant to its investigational ready-to-use (RTU) liquid formulation of IL-2. In particular, the U.S. Patent and Trademark Office (USPTO) has granted patent number US 12,312,389 B2, which covers methods of producing highly stable liquid formulations of IL-2 (aldesleukin). Through an existing agreement, Coya has the exclusive in-vivo rights to this patent and other related intellectual property spanning multiple indications both as monotherapy and combination therapies...Coya is on track and plans to submit the IND for COYA 302 (a proprietary combination of the low dose-rhIL-2 + CTLA4-Ig) by the end of June supporting the initiation of the Phase 2b study in patients with ALS"

IND • New P2b trial • Patent • Amyotrophic Lateral Sclerosis

Coya Therapeutics Reports First Quarter Financial Results and Provides a Corporate Update (Businesswire) - "Research and development (R&D) expenses were $5.2 million for the three months ended March 31, 2025, compared to $3.1 million for the three months ended March 31, 2024. The change was primarily due to a $1.5 million increase in our preclinical expenses primarily due to the Company’s preclinical advancement of COYA 302 in ALS, a $0.4 million increase in internal research and development expenses, and a $0.1 million increase in sponsored research."

Commercial • Amyotrophic Lateral Sclerosis

Coya Therapeutics Provides a Corporate Update and Reports Fiscal 2024 Financial Results (Businesswire) - "Q2 2025: Submission of additional nonclinical data to support the start of the COYA-302 Phase 2 trial in patients with ALS; Upon IND acceptance and first patient dosing of COYA-302 in ALS, eligible to receive milestone payments of $8.4 million from strategic partner, Dr. Reddy’s Laboratories (DRL); Q2 2025: Publication of COYA-303 combination mechanistic data; Q2 2025: Publication of data documenting role of inflammation in Parkinson’s Disease; Q2 2025: ALS Biomarker data. Publication of longitudinal data on Neurofilament Light Chain (NfL) and oxidative stress markers in patients with ALS."

Biomarker • Clinical data • IND • Preclinical • Amyotrophic Lateral Sclerosis • Immunology • Inflammation

Coya Therapeutics Provides a Corporate Update and Reports Fiscal 2024 Financial Results (Businesswire) - "2H 2025: 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); 2H 2025: Top-line clinical data release for an investigator-initiated trial combining LD IL-2 + CTLA4-Ig in patients with FTD; 2H 2025: Filing of IND for the COYA-302 Phase 2 trial in patients with FTD."

Clinical data • IND • P2 data • Alzheimer's Disease • Dementia

Coya Therapeutics Provides Enrollment Update of the Investigator-Initiated Phase 1 Study of Low Dose Interleukin-2 (LD IL-2) + CTLA4-Ig Fusion Protein in Patients with Frontotemporal Dementia (FTD) (Businesswire) - "Coya Therapeutics, Inc...announces that five of eight patients have been enrolled in the investigator-initiated academic study of LD IL-2 + CTLA4-Ig combination in patients with Frontotemporal Dementia (FTD). The study is being conducted by Drs. Stanley Appel and Alireza Faridar at Houston Methodist Hospital. Topline results of the study will be leveraged to inform and finalize the planned trial design of a Company-sponsored, randomized, double-blinded Phase 2 trial of COYA 302 in patients with FTD. Coya has been awarded $5 million by the Alzheimer’s Drug Discovery Foundation (ADDF) to support the development of COYA 302 in FTD."

Enrollment status • Financing • CNS Disorders • Dementia

Coya Therapeutics Provides a Corporate Update and Reports Unaudited Third Quarter 2024 Financial Results (Businesswire) - "Q2 2025: Submission of additional data to support the start of the COYA-302 Phase 2 trial in patients with ALS...2H 2025: Top-line clinical data release for an investigator-initiated trial combining LD IL-2 + CTLA4-Ig in patients with FTD; 2H 2025: Filing of IND for the COYA-302 Phase 2 trial in patients with FTD."

Clinical data • IND • P2 data • Amyotrophic Lateral Sclerosis • CNS Disorders • Dementia

Coya Therapeutics Announces Subcutaneously Administered COYA 302 Elicits Direct Anti-Inflammatory Effect in Brain in a Preclinical Inflammatory Mouse Model of Parkinson’s Disease (Businesswire) - "In an inflammatory mouse model of PD, subcutaneous injections of COYA 302 significantly reduced inflammation and microglial activation in nigrostriatal brain regions responsible for motor control...Microglial inhibition may hold promise as a therapeutic strategy to delay the progression of PD. Additionally, subcutaneous injections of COYA 302 resulted in reductions in astrocyte numbers and their activation (astrogliosis) in the nigrostriatal pathway. It is known that pathogenic astrocyte activation leads to neurodegeneration in PD, and mitigating its damage may be another therapeutic target."

Preclinical • CNS Disorders • Parkinson's Disease

Coya Therapeutics Provides a Corporate Update and Reports Unaudited Second Quarter 2024 Financial Results (Businesswire) - "On August 9, 2024, FDA provided feedback that additional non-clinical toxicology/pharmacology data must be submitted prior to initiating our planned randomized, double-blind, placebo-controlled Phase 2 study of our first-in-class biologic combination COYA 302 in patients with ALS. Coya intends to discuss the recommendations with the FDA in 4Q 2024 to align on our revised non-clinical package to enable the implementation of the study...We believe data from this Phase 1 trial is supportive of COYA 302 as a potential treatment for ALS and submitted an IND to the FDA in the second quarter of 2024...Lastly, in Parkinson’s disease, we anticipate releasing animal model data highlighting the potential therapeutic effects of COYA 302 by the end of the year."

FDA event • IND • Preclinical • Amyotrophic Lateral Sclerosis • CNS Disorders • Parkinson's Disease

Coya Therapeutics Announces that Results from a Double-Blind Placebo-Controlled Study in Alzheimer’s Disease will be presented on October 29, 2024 at the Clinical Trials on Alzheimer’s Disease Conference (CTAD24) in Madrid (Businesswire) - "Coya Therapeutics, Inc...announces that data from the IIT, a double-blind, placebo-controlled, phase 2 clinical trial of interleukin-2 (IL-2) in patients with mild to moderate Alzheimer's Disease, conducted at Houston Methodist Research Institute and supported by the Gates Foundation and the Alzheimer’s Association will be presented at the 17th edition of the Clinical Trials on Alzheimer’s Disease Conference (CTAD24), to be held in Madrid, Spain on October 29 - November 1, 2024."

P2 data • Alzheimer's Disease • CNS Disorders

Coya Therapeutics faces FDA hold on ALS drug study (Investing.com) - "Coya Therapeutics, Inc...has encountered a regulatory setback with the U.S. Food and Drug Administration (FDA) requiring additional non-clinical data before proceeding with a planned study on its investigational drug for Amyotrophic Lateral Sclerosis (ALS). The FDA's request for more information was communicated to the company via email on July 12, 2024, delaying the initiation of the Phase 2 clinical trial...However, the FDA's recent correspondence has put a hold on the study's commencement, pending the submission of the requested additional data. Coya Therapeutics has been advised to expect further details on the FDA's requirements within the next 30 days."

FDA event • Amyotrophic Lateral Sclerosis • CNS Disorders

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 Announces Publication of ALS Study in Peer-Reviewed Journal Frontiers in Neurology (Businesswire) - P1 | N=5 | NCT06307301 | "'Coya remains on track to file its Investigational New Drug Application (IND) with the Food and Drug Administration (FDA) for its proposed randomized double blind placebo controlled study for LD IL-2 + CTLA4-Ig in ALS this month (June, 2024).'...Treatment was well tolerated among all patients. There were no serious adverse events...For all 4 participants, the mean rate of change in the ALSFRS-R over the first 24 weeks was stable (+0.04 points/month). During this time period, the ALSFRS-R improved by 4 points in participant #1, improved by 3 points in participant #2, was unchanged in participant #3, and decreased by 6 points in participant #4."

IND • P1 data • Amyotrophic Lateral Sclerosis • CNS Disorders

Coya Therapeutics Announces the Completion of a Controlled Phase 2 Study of Low Dose Interleukin-2 (LD IL-2) in Patients with Alzheimer’s Disease (Businesswire) - P2 | N=NA | "Coya Therapeutics, Inc...announces the completion of a randomized, double-blind, placebo-controlled Phase 2 study of LD IL-2 in patients with mild-to-moderate AD....Topline results of the study are still anticipated to be reported in summer of 2024....In addition, an evaluation of cognitive function showed that administration of LD IL-2 resulted in a statistically significant improvement in mean Mini-Mental State Examination (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 LD IL-2, compared to pre-treatment baseline scores, indicating no cognitive decline as measured by these validated instruments."

P2 data • Trial completion • Alzheimer's Disease • CNS Disorders

Coya Therapeutics to Participate in the 3rd Annual ALS Drug Development Summit (Businesswire) - "Coya Therapeutics, Inc...announces that President and Chief Medical Officer Dr. Fred Grossman, D.O., FAPA will participate in the 3^rd Annual ALS Drug Development Summit being held May 21 – 23 at the Hyatt Regency in Boston."

Clinical • Amyotrophic Lateral Sclerosis • CNS Disorders • Immunology

Coya Therapeutics Presents ALS Biomarker Data at Society of Neuroimmune Pharmacology Conference (Yahoo Finance) - "Coya Therapeutics, Inc...announces that Dr. Stanley Appel, M.D., Chairman of Coya’s Scientific Advisory Board and Dr. David Beers, Ph.D., Associate Research Professor of Neurology, Houston Methodist, will present biomarker data today as part of a panel presentation at the Society of Neuroimmune Pharmacology Conference....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..."

Clinical data • Amyotrophic Lateral Sclerosis • CNS Disorders

Coya Therapeutics Presents Biomarker Data on Neuroinflammatory Pathways in Frontotemporal Dementia (FTD) at the AD/PD 2024 Conference (Businesswire) - "Coya Therapeutics, Inc...announces the presentation of data demonstrating the role of the peripheral immune system in the pathophysiology of Frontotemporal Dementia (FTD) from a biomarker study conducted at the Houston Methodist Hospital by Dr. Stanley Appel and Dr. Alireza Faridar and funded by the Houston Methodist Clinical Scholar Award Program....'We intend to file an Investigational New Drug (IND) application with the FDA for COYA 302 in FTD later this year and initiate a Ph. 2 trial in FTD patients shortly thereafter'...Treg Function Compromised: Treg suppressive function was significantly reduced in FTD, compared to controls (p<0.01), demonstrating that Treg immunomodulatory function is negatively impacted in FTD."

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

Coya Therapeutics to Present Data on Immune System and Regulatory T Cell (Treg) Contributions in Frontotemporal Dementia (FTD) Patients at AD/PD 2024 Conference (Businesswire) - "Coya Therapeutics, Inc...announces that Dr. Alireza Faridar, the Stanley H. Appel Chair in Translational Neuroscience, Stanley H. Appel Department of Neurology at Houston Methodist, will present data showing the contribution of chronic systemic inflammation and dysfunctional Tregs in Frontotemporal Dementia (FTD) patients at the AD/PD 2024 Conference. The AD/PD 2024 Conference will be held March 5-9, 2024 in Lisbon, Portugal....'This presentation will highlight the complexity of neuroinflammatory pathways, providing the rationale for our planned IND filing for COYA 302, our combination therapeutic candidate, in FTD patients in 4Q24.'"

Clinical • IND • Alzheimer's Disease • CNS Disorders • Dementia • Parkinson's Disease

Coya Therapeutics to Present Novel Biomarker Survival Data in Large Cohort of ALS (Amyotrophic Lateral Sclerosis) Patients at Society of Neuroimmune Pharmacology Conference (Businesswire) - "Coya Therapeutics, Inc...announces that Dr. Stanley Appel, M.D., Chairman of Coya’s Scientific Advisory Board, will present data on its novel oxidative stress biomarker candidate from a large cohort of Amyotrophic Lateral Sclerosis (ALS) patients at the upcoming Society of Neuroimmune Pharmacology Conference being held on March 10-13, 2024 in Charleston, SC. Dr. Appel’s presentation will be on Tuesday, March 12th, 2024....'We believe that our preliminary novel biomarker data may facilitate new opportunities to better predict patient survival, monitor disease progression, and track efficacy of therapies and will be an important part of the analysis in the upcoming Ph. 2 COYA 302 ALS study.'"

Clinical data • Amyotrophic Lateral Sclerosis • CNS Disorders • Immunology

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

Coya Therapeutics, Inc. and Dr. Reddy’s Laboratories Enter into an Exclusive Collaboration for Development and Commercialization of COYA 302, an Investigational Combination Therapy for Treatment of Amyotrophic Lateral Sclerosis (ALS) (Businesswire) - "Dr. Reddy's Laboratories SA, wholly-owned subsidiary of Dr. Reddy’s Laboratories Ltd...and Coya Therapeutics, Inc...announced that they have entered into a development and license agreement (the 'Agreement') for the development and commercialization of COYA 302, an investigational combination therapy for the treatment of Amyotrophic Lateral Sclerosis (ALS). Under the terms of the Agreement, Coya has granted Dr. Reddy’s an exclusive license to commercialize COYA 302, a proprietary co-pack kit containing combination of low dose IL-2 and CTLA-4 Ig (abatacept) in the United States, Canada, the European Union and the United Kingdom for ALS."

Licensing / partnership • Amyotrophic Lateral Sclerosis • CNS Disorders • Immunology

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 Therapeutics Presents New Experimental Data Supporting the Mechanism of Action of COYA 302 for the Treatment of Amyotrophic Lateral Sclerosis (ALS) at the 22nd Annual Northeast ALS (NEALS) Consortium Meeting (Businesswire) - "Coya Therapeutics, Inc...announced new experimental data presented at the 22nd Annual Northeast ALS (NEALS) Consortium Meeting on October 4th, 2023...Main results of the study are summarized below: M1 activated monocytes and macrophages reduce Treg viability and upregulate apoptosis markers; Immunomodulatory drugs known to suppress the M1 phenotype significantly decreased the production of inflammatory cytokines involved in tissue damage; The combination of LD IL-2/CTLA4-Ig significantly decreased the M1 phenotype and cytokine production and maintained Treg viability....Results of this study further support the potential of COYA 302 (LD IL-2 and CTLA4-Ig) to address the multiple pathways involved in the progression and severity of ALS."

Preclinical • Amyotrophic Lateral Sclerosis • CNS Disorders • Immunology

Coya Therapeutics, Inc. Provides Business Update and Reports Q2 2023 Unaudited Financial Results (Businesswire) - "COYA 302 (ld IL-2 + CTLA4 Ig): ALS PoC IIT data publication in peer reviewed journal (H2 2023); Biomarker data release for PoC study (H2 2023); Pre-IND meeting with FDA (H2 2023); IND Filing (Q1 2024); Initiate Phase 2 trial in ALS (following IND Filing); COYA 301 (ld IL-2): AD PoC IIT data presentation (American Neurological Association, September 2023); AD PoC IIT data publication in peer reviewed journal (H2 2023); Topline data of academic investigator Initiated Phase 2 double blind trial in Alzheimer’s Disease (1H 2024)..."

FDA event • IND • New P2 trial • P1 data • Amyotrophic Lateral Sclerosis • CNS Disorders • Immunology

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