# IND-enabling Preclinical Studies for Aβ and Dual Aβ/Tau MultiTEP platform-based AD Vaccines

> **NIH NIH U01** · INSTITUTE FOR MOLECULAR MEDICINE · 2021 · $1,346,072

## 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 effective vaccines are effective
when they are used as a preventive treatment. Accordingly, we are seeking a revision to U01
AG060965 that will support a submission of INDs to the FDA for future clinical trials that will allow
us to sequentially or concurrently treat early AD subjects with extremely immunogenic Aβ and tau
vaccines based on the same and very immunogenic MultiTEP platform and novel adjuvant
AdvaxCpG. 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 AV-1959R/A vaccine could be used as a preventive measure in healthy people at risk
of MCI (based on biomarkers) and later used to vaccinate MCI people with the AV-1980R/A
vaccine or their combination to delay AD.

## Key facts

- **NIH application ID:** 10122640
- **Project number:** 3U01AG060965-03S1
- **Recipient organization:** INSTITUTE FOR MOLECULAR MEDICINE
- **Principal Investigator:** Michael G Agadjanyan
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,346,072
- **Award type:** 3
- **Project period:** 2019-02-01 → 2023-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10122640

## Citation

> US National Institutes of Health, RePORTER application 10122640, IND-enabling Preclinical Studies for Aβ and Dual Aβ/Tau MultiTEP platform-based AD Vaccines (3U01AG060965-03S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10122640. Licensed CC0.

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