VY7523 / Voyager - LARVOL DELTA

Pipeline updates (Yahoo Finance) - "VY1706 (tau-silencing gene therapy): Voyager expects completion of a good laboratory practice (GLP) toxicology study in Q1 2026, investigational new drug (IND) application submission in Q2 2026, and first-in-human dosing in H2 2026. Following a pre-IND communication with U.S. Food and Drug Administration (FDA) in Q1 2025, Voyager completed a Type C communication with FDA in Q1 2026 and believes there to be a path to IND...H2: Tau PET imaging data expected in MAD clinical trial of VY7523 in AD."

First-in-human • IND • P1/2 data • Preclinical • Alzheimer's Disease

The primary focus for the upcoming year centers on two Alzheimer's programs, both scheduled for the second half of 2026 (AD HOC NEWS) - "Clinical Phase 1 initiation is planned for H2 2026 for VY1706, a gene therapy candidate; Study data for the Alzheimer's antibody VY7523 is expected in H2 2026."

New P1 trial • P1/2 data • Alzheimer's Disease

Study Design of a Multiple Ascending Intravenous Dose Study Evaluating the Safety, Tolerability, Pharmacokinetics of VY7523 in Participants with Early Alzheimer's Disease (CTAD 2025) - No abstract available

Clinical • PK/PD data • Alzheimer's Disease • CNS Disorders

Results of a Phase 1, randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, and pharmacokinetics of ascending single IV doses of VY7523, a tautargeting therapeutic, in healthy adult participants (CTAD 2025) - No abstract available

Clinical • P1 data • PK/PD data

Anticipated Upcoming Milestones (GlobeNewswire) - "(i) 2025-2026: Potentially informative data read-outs expected for tau-targeting agents from multiple third parties; (ii) 2026: U.S. IND/Canadian CTA submissions + clinical trial initiation anticipated for VY1706 in AD; (iii) 2026: Neurocrine indicates potential clinical trial initiations for FA and GBA1 programs; (iv) H2 2026: Initial tau PET imaging data expected in MAD clinical trial of VY7523 in AD."

Clinical data • New trial • Alzheimer's Disease • Friedreich ataxia

Second Quarter 2025 and Recent Highlights (GlobeNewswire) - "VY7523 (anti-tau antibody): initial tau positron emission tomography (PET) data from clinical trial in Alzheimer’s disease (AD) patients expected in the second half of 2026...Potential for data from multiple gene therapy programs: Neurocrine-partnered FA and GBA1 programs anticipated to enter clinical trials in 2026; VY1706 tau silencing gene therapy anticipated to enter a clinical trial in 2026; Critical third-party data from large Phase 2 studies of an anti-tau antibody and tau knockdown program expected in 2026, which have the potential to further validate tau as a target....VY1706 (tau silencing gene therapy): IND-enabling work is underway to support an IND and clinical trial initiation expected in 2026."

Clinical data • IND • New trial • Alzheimer's Disease • Friedreich ataxia

Voyager Reports Positive Topline Data for Single Ascending Dose (SAD) Trial of Anti-Tau Antibody VY7523 and Initiates Multiple Ascending Dose (MAD) Trial in Alzheimer’s Disease (GlobeNewswire) - P=NA | N=48 | "VY7523 was well tolerated across all six ascending dose cohorts, meeting the primary objective of the trial, with no serious adverse events (SAEs), severe adverse events, or infusion reactions reported. Secondary objectives of the trial were also met. Serum concentrations increased in a dose-proportionate manner, and the cerebrospinal fluid (CSF)-to-serum ratio was 0.3%, consistent with other monoclonal antibodies approved for the treatment of AD. Voyager expects to present additional data from the SAD study at an upcoming scientific conference."

Clinical data • Alzheimer's Disease

Voyager Reports Fourth Quarter and Full Year 2024 Financial and Operating Results (GlobeNewswire) - P1 | N=NA | "Initiated multiple ascending dose (MAD) study of VY7523 anti-tau antibody for AD: VY7523 demonstrated an acceptable safety, tolerability, and immunogenicity profile as well as expected pharmacokinetic results in a Phase 1, single ascending dose (SAD) clinical trial in healthy volunteers. No serious adverse events (SAEs), severe adverse events, or infusion reactions were reported, and the cerebrospinal fluid (CSF)-to-serum ratio was 0.3%. Initial tau positron emission tomography (PET) data from the recently initiated MAD study are expected in the second half of 2026."

P1 data • Alzheimer's Disease

Drug Development. (PubMed, Alzheimers Dement) - "The PK of Ab-01 in the P301S mouse and VY-TAU01 in the cynomolgus macaque, and CSF to serum ratios were typical of murine IgG1 and human IgG4 administered to these respective species. The PD of Ab-01 in the P301S mouse demonstrated robust lowering of unbound p-tau. These results support VY-TAU01's continued development and advancement into the clinic."

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • MAPT

Voyager Reports Third Quarter 2024 Financial and Operating Results (GlobeNewswire) - "Anticipated Upcoming Milestones: H1 2025: Initial safety and pharmacokinetic data expected from VY7523 SAD clinical trial; Mid-2025: U.S. IND and Canadian clinical trial application (CTA) filings expected with SOD1 silencing gene therapy VY9323 in ALS patients, subsequent clinical trial has potential to generate proof-of-concept based on biomarkers; 2025: Initiation of Multiple Ascending Dose (MAD) clinical trial in AD patients expected with VY7523...2026: U.S. IND and Canadian CTA filings anticipated with tau silencing gene therapy for Alzheimer’s disease; H2 2026: Initial tau PET imaging data expected in MAD clinical trial of VY7523 in Alzheimer’s disease."

Clinical data • IND • New trial • Alzheimer's Disease • Amyotrophic Lateral Sclerosis • CNS Disorders

Voyager Therapeutics Reports Second Quarter 2024 Financial and Operating Results (GlobeNewswire) - "'Voyager continued to progress our pipeline in the second quarter: we initiated the single ascending dose trial of our anti-tau antibody...and enrollment is on track with top-line safety and pharmacokinetic data expected in H1 2025'...'In parallel, we continued to advance our gene therapy pipeline, and we and our partners are on track to achieve three IND filings in 2025.'...Dosed first participants in Phase 1a single ascending dose (SAD) trial of anti-tau antibody VY7523 (formerly VY-TAU01) for Alzheimer’s disease...VY9323 SOD1 silencing gene therapy program for SOD1 ALS: Voyager expects to file an IND in mid-2025 and initiate a clinical trial in SOD1 ALS patients...Voyager and Neurocrine Biosciences expect to file INDs for the GBA1 and Friedreich’s Ataxia gene therapy programs in 2025, as previously disclosed."

IND • P1 data • Trial status • Alzheimer's Disease • Amyotrophic Lateral Sclerosis • CNS Disorders

Pharmacokinetics and Pharmacodynamics of an Antibody Targeting Pathological Tau for the Treatment of Alzheimer’s Disease: Nonclinical Studies in P301S Mice and Cynomolgus Macaques (AAIC 2024) - "The PK of Ab-01 in the P301S mouse and VY-TAU01 in the cynomolgus macaque, and CSF to serum ratios were typical of murine IgG1 and human IgG4 administered to these respective species. The PD of Ab-01 in the P301S mouse demonstrated robust lowering of unbound p-tau. These results support VY-TAU01’s continued development and advancement into the clinic."

PK/PD data • Preclinical • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • MAPT

PHARMACOKINETICS AND TOLERABILITY OF VY-TAU01, AN ANTI-TAU ANTIBODY FOR THE TREATMENT OF ALZHEIMER'S DISEASE, IN P301S MOUSE AND NONHUMAN PRIMATE (ADPD 2024) - "Initial studies demonstrated that Ab-01 and VY-TAU01 are well-tolerated in P301S mice and NHP, respectively, and that the serum PK profile is as expected."

PK/PD data • Preclinical • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Dementia • MAPT

Voyager Therapeutics Reports Third Quarter 2023 Financial and Operating Results (GlobeNewswire) - "VY-TAU01 anti-tau antibody program for Alzheimer’s disease: Voyager expects to file an IND in the first half of 2024. SOD1 gene therapy program for amyotrophic lateral sclerosis (ALS): Voyager expects to identify a lead development candidate in 2023 to support an IND in mid-2025. Voyager and Neurocrine Biosciences collaboration: Voyager and Neurocrine Biosciences continue to collaboratively advance the GBA1 gene therapy program for Parkinson’s disease and other GBA1-mediated diseases, as well as the FXN gene therapy program for Friedreich’s Ataxia."

IND • Licensing / partnership • Pipeline update • Alzheimer's Disease • Amyotrophic Lateral Sclerosis • CNS Disorders • Parkinson's Disease

Voyager Therapeutics Reports First Quarter 2023 Financial and Operating Results (GlobeNewswire) - "Upcoming Milestones: SOD1 gene therapy program for amyotrophic lateral sclerosis (ALS): Voyager previously announced that it expected to identify a lead development candidate for this program in the first half of 2023. The Company continues to evaluate the data from preclinical studies for this program and now expects to identify a lead development candidate in the second half of 2023; Advancement of anti-tau antibody program: In January 2023, Voyager selected a lead humanized anti-tau antibody candidate, VY-TAU01, to advance for the treatment of Alzheimer’s disease...Voyager continues to expect to initiate GLP toxicology studies this year to enable an IND filing in the first half of 2024."

IND • New molecule • Pipeline update • Alzheimer's Disease • Amyotrophic Lateral Sclerosis • CNS Disorders • Tauopathies And Synucleinopathies

Voyager Therapeutics Reports Fourth Quarter and Full Year 2022 Financial and Operating Results (GlobeNewswire) - "VY-TAU01 was selected for its affinity, selectivity, and biophysical characteristics. Voyager expects to present additional data at the AD/PD 2023 Conference, March 28 – April 1, 2023. Process development and manufacturing at a CDMO have been initiated, and Voyager expects to initiate a GLP toxicology study later in 2023 to enable an IND filing in the first half of 2024."

IND • Preclinical • Alzheimer's Disease • CNS Disorders • Dementia