# Manufacturing of New Batch AV-1959D Drug Product and Placebo for Phase 1 Trial

> **NIH NIH R01** · INSTITUTE FOR MOLECULAR MEDICINE · 2023 · $699,000

## Abstract

Abstract
Immunotherapy targeting pathological Aβ continues to be a promising therapeutic strategy for Alzheimer's
Disease (AD) prevention. Published data suggested that inhibition of amyloid aggregation in people at risk of AD
could delay AD onset. However, due to the treatment schedule and the cost of monoclonal antibodies, their
passive administration may not be the best preventive treatment strategy. Therefore, we hypothesized that our
universal MultiTEP-platform-based active vaccine, AV-1959D, could be an inexpensive alternative to the passive
vaccination strategy. To move further with this program, our multidisciplinary team manufactured a clinical grade
AV-1959D vaccine and completed comprehensive IND-enabling safety, efficacy, and immunogenicity studies in
mouse models of AD, rabbits, and monkeys. As a result of these studies conducted within the scope of an NIA
cooperative agreement (U01 AG048310), we generated data for the preparation of IND18953 for Phase 1 AV-
1959D clinical trials that the FDA cleared in 2020, prepared 200 mg (225 vials, 145 of which was used for release
test and 3Y stability) cGMP AV-1959D for future phase 1 clinical trial and submitted the grant application for
clinical trial "Determine the safety/tolerability and immunogenicity of ascending doses of AV-1959D in patients
with early-stage AD" in February of 2019. We received funding from NIA only in 2022, after two years and three
attempts, to begin the first human clinical trial of AV-1959D. Hence, we had to adjust our clinical program based
on new information and regulatory recommendations outlined in this Administrative Supplement. More
specifically, we extended the stability testing of the drug product up to five years and increased doses for the
intradermal delivery of the AV-1959D vaccine based on new data obtained in COVID-19 trials with the first
approved DNA vaccine delivered by Pharmajet Tropis®. These amendments required additional drug product
vials for the Phase 1 trial. Accordingly, this administrative supplement program aims to justify manufacturing a
new GMP batch of the AV-1959D vaccine as early as possible to initiate the Phase 1 trial in Y1 of this program.

## Key facts

- **NIH application ID:** 10732215
- **Project number:** 3R01AG074983-02S1
- **Recipient organization:** INSTITUTE FOR MOLECULAR MEDICINE
- **Principal Investigator:** Michael G Agadjanyan
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $699,000
- **Award type:** 3
- **Project period:** 2022-02-15 → 2027-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10732215

## Citation

> US National Institutes of Health, RePORTER application 10732215, Manufacturing of New Batch AV-1959D Drug Product and Placebo for Phase 1 Trial (3R01AG074983-02S1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10732215. Licensed CC0.

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