UB-313 / Vaxxinity - LARVOL DELTA

A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-313 in Healthy Participants (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Vaxxinity, Inc. | Active, not recruiting ➔ Completed

Trial completion • CNS Disorders • Migraine • Pain

UB-313, an Investigational CGRP Vaccine for the Prevention of Migraine (AAN 2023) - "Interestingly, induced by UB-313 demonstrate a stronger potency against human CGRP than rat CGRP, despite a single amino acid substitution between Importantly, immunization of rats with the murine version of UB-313 prevented the of capsaicin on dermal blood flow to a similar extent as treatment with Galcanezumab. UB-313 has now advanced to clinical development: the ongoing Phase 1 trial is designed to assess immunogenicity and target engagement (capsaicin-induced increase in dermal blood now). As a potentially saÉ and immunotherapy against CGRP, 08-313 may represent an affordable and convenient to prevent migraine."

Late-breaking abstract • CNS Disorders • Migraine

Vaxxinity to Present at World Vaccine Congress, American Academy of Neurology, and BNA2023 Festival of Neuroscience in April (GlobeNewswire) - “UB-313 to be Featured in Emerging Science Presentation at AAN Annual Meeting. Vaxxinity, Inc…announced that members of its leadership team will present data on investigational vaccines for COVID-19 and neurodegenerative diseases at three upcoming scientific and medical conferences in April.”

Clinical • CNS Disorders • Migraine • Pain

A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-313 in Healthy Participants (clinicaltrials.gov) - P1 | N=40 | Active, not recruiting | Sponsor: Vaxxinity, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Migraine

Vaxxinity Announces First Subjects Dosed in Phase 1 Clinical Trial of UB-313 for Preventive Treatment of Migraine (GlobeNewswire) - "Vaxxinity, Inc...announced that the first subjects have been dosed in a Phase 1 clinical trial of UB-313, a vaccine targeting calcitonin gene-related peptide (CGRP), for the preventive treatment of migraine....The Phase 1 randomized, placebo-controlled, double-blind, multidose trial will enroll approximately 40 healthy volunteers at the Center for Clinical Pharmacology, UZ Leuven in Belgium. The objectives of the trial are to evaluate safety, tolerability, and immunogenicity. Immunogenicity will be measured by serum anti-CGRP antibody titers. Pharmacodynamics of the immune response will be measured by the inhibition of capsaicin-induced increase in dermal blood flow, an established model of target engagement in migraine."

Trial status • CNS Disorders • Migraine • Pain

Vaxxinity Reports Second Quarter 2022 Financial Results and Provides Corporate Updates (GlobeNewswire) - "Vaxxinity, Inc...today reported financial results for the second quarter ended June 30, 2022....Subsequent to the quarter-end, Vaxxinity began enrolling healthy volunteers into a Phase 1 clinical trial evaluating UB-313 for safety, tolerability, and immunogenicity. The trial also includes target engagement as a secondary endpoint in the form of capsaicin-induced dermal blood flow, a well established biomarker. Vaxxinity expects to report initial data from the Phase 1 study in 1H23."

Enrollment open • P1 data • CNS Disorders • Migraine • Pain

A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-313 in Healthy Participants (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Vaxxinity, Inc.

New P1 trial • CNS Disorders • Migraine

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