# Cooperative program U01 AG060965 Supplement: "Preparation of IND for Dual Aβ/Tau AD Vaccine for submission to FDA"

> **NIH NIH U01** · INSTITUTE FOR MOLECULAR MEDICINE · 2022 · $297,719

## Abstract

Project Summary
Immunotherapy is still considered a very promising therapeutic strategy for AD prevention when
certain conditions are met. Data from various immunotherapeutic studies support our long-
standing tenet that immunogenic AD vaccines could at least delay disease progression when they
target both Aβ and Tau pathological molecules at an early stage of the disease before AD
manifestation. It is impractical to use very expensive mAbs as a preventive treatment of healthy
subjects due to the need for frequent (monthly) administration of high concentrations (700-800mg
per IV injection) of this immunotherapeutic. In contrast, almost all vaccines are effective in
preventive settings. Accordingly, we seek an administrative supplement to U01 AG060965 that
will support the preparation and submission of regulatory documents to the FDA to support the
initiation of Phase 1 clinical trial of the dual preventive vaccine. Our proprietary vaccine platform
can stimulate adaptive immunity, providing broad coverage of human MHC polymorphisms and
activating both naive Th cells and pre-existing memory Th cells generated in response to
conventional vaccines and/or infections with various pathogens during one's lifespan without the
activation of harmful autoreactive T cells. These "non-self" Th cells should activate B cells and
induce the production of therapeutically potent antibodies specific to pathological Aβ and Tau in
humans similar to that we observed in inbred WT and Tg mice as well as outbred rabbits and
monkeys. If safe and immunogenic in Phase 1 trials, the combined AV-1959R/A, and AV-1980R/A
vaccines could be used as a preventive measure in healthy people at risk of MCI (based on
biomarkers) to delay AD.

## Key facts

- **NIH application ID:** 10505652
- **Project number:** 3U01AG060965-04S1
- **Recipient organization:** INSTITUTE FOR MOLECULAR MEDICINE
- **Principal Investigator:** Michael G Agadjanyan
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $297,719
- **Award type:** 3
- **Project period:** 2019-02-01 → 2025-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10505652

## Citation

> US National Institutes of Health, RePORTER application 10505652, Cooperative program U01 AG060965 Supplement: "Preparation of IND for Dual Aβ/Tau AD Vaccine for submission to FDA" (3U01AG060965-04S1). Retrieved via AI Analytics 2026-06-12 from https://api.ai-analytics.org/grant/nih/10505652. Licensed CC0.

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