UB 312 / Vaxxinity - LARVOL DELTA

An update on immune-based alpha-synuclein trials in Parkinson's disease. (PubMed, J Neurol) - "Specifically, UB-312, AFFITOPE PD01A, PD03A and ACI-7104.056 are designed to provoke an immune response against α-syn (active immunisation), while Prasinezumab and Cinpanemab, MEDI1341 and Lu AF82422 focus on directly targeting α-syn aggregates (passive immunisation). Despite some promising results, challenges such as variable efficacy and trial discontinuations persist. Future research must address these challenges to advance disease-modifying therapies for PD around this therapeutic target."

Journal • Review • CNS Disorders • Movement Disorders • Parkinson's Disease

A Phase 1b Randomized, Placebo-Controlled, Delayed-Start Trial of UB-312 in Synucleinopathies. (MDS Congress 2024) - "Following immunization with priming doses, UB-312-specific antibodies were detectable. To date, the vaccine demonstrates a well-tolerated safety profile. Data collection is ongoing and additional data will be shared at the conference."

Clinical • P1 data • CNS Disorders • Multiple System Atrophy • Parkinson's Disease

UB-312 in Patients With Synucleinopathies (clinicaltrials.gov) - P1/2 | N=8 | Active, not recruiting | Sponsor: NYU Langone Health | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Movement Disorders • Multiple System Atrophy • Parkinson's Disease

Target engagement and immunogenicity of an active immunotherapeutic targeting pathological α-synuclein: a phase 1 placebo-controlled trial. (PubMed, Nat Med) - P1 | "These data support further UB-312 development. ClinicalTrials.gov: NCT04075318 ."

IO biomarker • Journal • P1 data • CNS Disorders • Movement Disorders • Parkinson's Disease

Vaxxinity UB-312 Parkinson’s Trial Results Published in Nature Medicine (GlobeNewswire) - P1 | N=70 | NCT04075318 | Sponsor: United Neuroscience Ltd. | "Vaxxinity, Inc...announced today that Nature Medicine has published groundbreaking exploratory data from the Company’s Phase 1 clinical trial of UB-312 in patients with Parkinson's disease (PD)....The Phase 1 successfully met its primary outcome measures, demonstrating UB-312 was generally well-tolerated and induced anti-αSyn antibody responses in healthy volunteers and PD patients....PD patients with UB-312-induced antibodies in CSF had significantly less αSyn aggregation (p <0.01) and pS129-αSyn (p <0.05) compared to patients without detectable CSF antibody titers. PD patients with UB-312-induced antibodies in CSF showed significant improvement in the MDS-UPDRS Part II motor experiences of daily living compared to patients without detectable CSF antibody titers (p<0.05)."

P1 data • CNS Disorders • Parkinson's Disease

UB-312 in Patients With Synucleinopathies (clinicaltrials.gov) - P1/2 | N=8 | Recruiting | Sponsor: NYU Langone Health | Phase classification: P1b ➔ P1/2

Phase classification • CNS Disorders • Movement Disorders • Multiple System Atrophy • Parkinson's Disease

Evidence of Target Engagement in a Phase 1 Clinical Trial of UB-312 in Parkinson's Disease (AAN 2024) - "Our data indicate that target engagement was achieved in the CSF of several treated PD patients. These encouraging data support further development of UB-312. Dosing optimization and trial in a larger patient population will be conducted to confirm these results."

Clinical • Late-breaking abstract • P1 data • CNS Disorders • Movement Disorders • Parkinson's Disease

Vaxxinity to Present Clinical Data at the Annual Academy of Neurology 2024 Annual Meeting (GlobeNewswire) - "Vaxxinity, Inc...today announced it will present clinical data from its UB-312 program in Parkinson’s disease at the Annual Academy of Neurology (AAN) 2024 Annual Meeting, taking place April 13-18, 2024 virtually and in Denver, Colorado."

P1 data • CNS Disorders • Parkinson's Disease

Vaxxinity Announces Positive Target Engagement Data from Phase 1 Clinical Trial for Parkinson’s Disease at AD/PD 2024 (GlobeNewswire) - P1 | N=70 | NCT04075318 | Sponsor: United Neuroscience Ltd. | "Vaxxinity, Inc...announced positive clinical data from its UB-312 program in Parkinson’s disease (PD) presented...at Vaxxinity in an oral session at the AD/PD 2024....The UB-312-induced antibodies showed preferential binding to aggregated aSyn and almost no binding to normal monomeric aSyn, as measured by dot blot. After a single priming regimen, those treated with UB-312 in the 300/100/100µg dosing group showed a 20% decrease from baseline in aggregated aSyn in the CSF compared to a 3% increase in the placebo group (p<0.05), as measured by a Seed Amplification Assay (SAA). Further, a post hoc analysis showed that patients with detectable UB-312-induced antibodies in the CSF exhibited improvement in activities of daily living as measured by the MDS-UPDRS II clinical scale (p<0.01)."

P1 data • CNS Disorders • Parkinson's Disease

A RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY WITH UB-312, AN ANTI-ALPHA-SYNUCLEIN PEPTIDE VACCINE IN PARKINSON'S DISEASE PATIENTS. (ADPD 2024) - "The trial met its primary objectives. UB-312 was generally safe, well tolerated, and induced anti-aSyn antibodies in serum and CSF. These data support further development of UB-312 for alpha-synucleinopathies."

Clinical • CNS Disorders • Movement Disorders • Parkinson's Disease

EVIDENCE OF TARGET ENGAGEMENT IN A PHASE 1 CLINICAL TRIAL OF UB-312 IN PARKINSON'S DISEASE (ADPD 2024) - "Our data indicate that target engagement was achieved in the CSF of several treated PD patients. These encouraging data support further development of UB-312. Dosing optimization and trial in a larger patient population will be conducted to confirm these results."

Clinical • P1 data • CNS Disorders • Movement Disorders • Parkinson's Disease

Vaxxinity to Present Clinical and Preclinical Pipeline Data at AD/PD 2024 (GlobeNewswire) - "Vaxxinity, Inc...today announced it will present clinical data from its UB-312 program in Parkinson’s disease and preclinical data from its anti-tau program in Alzheimer’s disease at the International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders (AD/PD 2024), taking place March 5-9, 2024 virtually and in Lisbon, Portugal."

P1 data • Preclinical • CNS Disorders • Parkinson's Disease

Study of UB-312 in Healthy Participants and Parkinson's Disease Patients (clinicaltrials.gov) - P1 | N=70 | Completed | Sponsor: United Neuroscience Ltd. | N=138 ➔ 70

Enrollment change • CNS Disorders • Movement Disorders • Parkinson's Disease

Vaxxinity Demonstrates Target Engagement of Toxic Alpha-Synuclein in Parkinson’s Patients (GlobeNewswire) - P1 | N=138 | NCT04075318 | Sponsor: United Neuroscience Ltd."Vaxxinity, Inc...today announced new data from a Phase 1 clinical trial demonstrating that antibodies derived from its investigational immunotherapeutic for Parkinson’s disease (PD), UB-312, slows seeding of alpha-synuclein (aSyn) in cerebrospinal fluid (CSF) of patients with PD as demonstrated using multiple target engagement assays. These data signify that UB-312 has established clear target engagement in PD patient CSF, and provides further validation of Vaxxinity’s platform technology in neurodegenerative disease."

P1 data • CNS Disorders • Parkinson's Disease

Vaxxinity Announces UB-312 Successfully Met Primary Objectives of Phase 1 Clinical Trial in Parkinson’s Disease (GlobeNewswire) - P1 | N=138 | NCT04075318 | Sponsor: United Neuroscience Ltd. | "Vaxxinity, Inc...announced positive results from Part B of its Phase 1 clinical trial of UB-312, an investigational vaccine for Parkinson’s disease (PD), demonstrating UB-312 was well-tolerated and induced anti-alpha-synuclein (aSyn) antibody responses in participants with early PD, meeting the primary objectives of the trial....Part B consisted of a 20-week treatment period followed by 24 weeks of observation. This study was conducted to evaluate the safety, tolerability and immunogenicity of UB-312 in patients with PD. Part B end-of-study results are as follows: The primary objectives were met. 92% of patients (12 out of 13) who completed dosing with UB-312 developed anti-aSyn antibodies. UB-312 was generally safe and well-tolerated with overall adverse event profile similar across UB-312 and placebo groups. Two patients experienced serious adverse events (SAEs)."

P1 data • CNS Disorders • Parkinson's Disease

UB-312 in Patients With Synucleinopathies (clinicaltrials.gov) - P1b | N=8 | Recruiting | Sponsor: NYU Langone Health | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Movement Disorders • Multiple System Atrophy • Parkinson's Disease

Study of UB-312 in Healthy Participants and Parkinson's Disease Patients (clinicaltrials.gov) - P1 | N=138 | Completed | Sponsor: United Neuroscience Ltd. | Active, not recruiting ➔ Completed | N=70 ➔ 138

Enrollment change • Trial completion • CNS Disorders • Movement Disorders • Parkinson's Disease

UB-312 in Patients With Synucleinopathies (clinicaltrials.gov) - P1b | N=8 | Not yet recruiting | Sponsor: NYU Langone Health | Trial completion date: Oct 2025 ➔ Apr 2025 | Initiation date: Dec 2022 ➔ Apr 2023 | Trial primary completion date: Oct 2025 ➔ Apr 2025

Trial completion date • Trial initiation date • Trial primary completion date • CNS Disorders • Movement Disorders • Multiple System Atrophy • Parkinson's Disease

UB-312 in Patients With Synucleinopathies (clinicaltrials.gov) - P1b | N=8 | Not yet recruiting | Sponsor: NYU Langone Health

New P1 trial • CNS Disorders • Movement Disorders • Multiple System Atrophy • Parkinson's Disease

Vaxxinity Reports Third Quarter 2022 Financial Results and Provides Corporate Update (GlobeNewswire) - “Research and development expenses were $12.5 million and $23.4 million for the three months ended September 30, 2022 and 2021, respectively. The $10.9 million decrease consisted of decreases in program-specific costs of $14.6 million and increases in non-program costs of $3.6 million. Of the program-specific decrease, $14.9 million was related to our UB-612 COVID-19 vaccine program, $0.7 million to our UB-311 Alzheimer’s disease program and $0.3 million to our UB-312 Parkinson’s disease program, partially offset by increases in spend of $1.3 million on our VXX-401 hypercholesterolemia program.”

Commercial • Alzheimer's Disease • CNS Disorders • Parkinson's Disease

Vaxxinity Reports Third Quarter 2022 Financial Results and Provides Corporate Update (GlobeNewswire) - P1 | N=70 | NCT04075318 | Sponsor: United Neuroscience Ltd. | "UB-312 Phase 1 Clinical Trial Part B Completes Last Patient Last Dose and End-of-Treatment Analysis: UB-312 targets toxic forms of aggregated α-synuclein in the brain to fight Parkinson’s disease (PD) and other synucleinopathies, such as dementia with Lewy bodies ('DLB') and multiple system atrophy ('MSA'). Phase 1 Part B end-of-treatment analysis suggests UB-312 is well tolerated and immunogenic in Parkinson’s patients. The Company expects an end-of-study readout in 2023. As part of the grant from The Michael J. Fox Foundation and in collaboration with the Mayo Clinic and the University of Texas, the company is also assessing exploratory biomarker endpoints for target engagement using protein misfolding cyclic amplification."

P1 data • Trial status • CNS Disorders • Dementia • Lewy Body Disease • Multiple System Atrophy • Parkinson's Disease

Study of UB-312 in Healthy Participants and Parkinson's Disease Patients (clinicaltrials.gov) - P1 | N=70 | Active, not recruiting | Sponsor: United Neuroscience Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Movement Disorders • Parkinson's Disease

Vaxxinity Reports Third Quarter 2021 Financial Results and Provides Corporate Updates (GlobeNewswire) - P1, N=70; NCT04075318; Sponsor: United Neuroscience Ltd; "Vaxxinity, Inc...today reported financial results for the third quarter ended September 30, 2021...Part A of a Phase 1 trial has shown UB-312 to be well tolerated in healthy volunteers, with no significant safety findings or serious adverse events, and immunogenic, with a high responder rate and antibodies that cross the blood-brain barrier. We have initiated enrollment of Parkinson’s patients for Part B of the Phase 1 trial; however, due to the requirement of booster shots against COVID-19 before participating in the clinical trial, initial dosing is now expected to occur in Q1 2022....UB-313 targets calcitonin gene-related peptide to fight migraines. Investigational new drug application (IND)-enabling studies are ongoing and we anticipate submitting a clinical trial application ('CTA') or an IND in 2022."

Enrollment status • IND • P1 data • Preclinical • CNS Disorders • Migraine • Pain • Parkinson's Disease

Vaxxinity Completes Enrollment in Part B of UB-312 Phase 1 Clinical Trial for Parkinson’s Disease (GlobeNewswire) - "Vaxxinity, Inc...today announced it has completed patient enrollment for Part B of its ongoing Phase 1 clinical trial of UB-312 in Parkinson’s disease (PD)....Vaxxinity also announced that results from Part A of the Phase 1 trial evaluating UB-312 in healthy volunteers were published in Movement Disorders....An end-of-treatment analysis is expected in the second half of 2022, with full analyses at end of study in 2023."

Enrollment closed • P1 data • CNS Disorders • Parkinson's Disease

A Randomized First-in-Human Study With UB-312, a UBITh® α-Synuclein Peptide Vaccine. (PubMed, Mov Disord) - "UB-312 was generally safe, well tolerated, and induced anti-αSyn antibodies in serum and CSF of healthy participants. The 100 and 300 μg doses are selected for further evaluation in participants with PD."

Journal • P1 data • CNS Disorders • Fatigue • Immunology • Infectious Disease • Movement Disorders • Pain • Parkinson's Disease