# Therapy and Prophylaxis for Genital Tract Infection

> **NIH NIH R44** · THERAPYX, INC. · 2021 · $1,000,000

## Abstract

PROJECT SUMMARY/ABSTRACT
Genital tract infection with Neisseria gonorrhoeae does not induce a state of specific protective immunity and
can be acquired repeatedly. Despite public health measures, the disease persists at an unacceptably high
frequency; there is no vaccine against it, and resistance even to the latest generations of antibiotics continues
to emerge. TherapyX, Inc. is advancing GneX12, a novel immune therapeutic that is designed to enhance
antibiotic-mediated clearance of persistent Neisseria gonorrhoeae infection and induce long-term protection
against subsequent exposure, i.e. a therapeutic vaccine. Specifically, GneX12 is the canonical type 1 cytokine
interleukin-12 (IL-12) encapsulated in proprietary biodegradable sustained-release microparticles. Phase I
studies in a murine model of gonoccal infection demonstrated that intra-vaginal administration of GneX12
achieved rapid disease clearance and induced the development of long-term protective immunity. Phase II work
optimized treatment schedule; demonstrated the critical role of Th1 immunity in disease clearance; revealed that
long-term protection was mediated by an anti-gonoccocal humoral response; that the antibodies were cross-
protective; and that co-administration with antibiotics did not interfere with the induction of long-term protection.
Additional Phase II work established scale-up manufacturing processes and completed a type C meeting with
the FDA, garnering agency agreement with our single species primate toxicology plan to support an investigative
new drug application (IND). The aims of the current Phase IIb application are based on agency recommendations
communicated during that meeting. Specifically, Aim 1 studies will complete additional toxicology, including
reproductive toxicology, assessment in rodents as recommend by FDA. In Aim 2, a large-batch “GMP-like”
GneX12 drug product is manufactured in compliance with FDA drug substance and drug product release
recommendations for use in IND-enabling, non-human primate toxicology studies. A meeting request and
package, including final CMC and pre-clinical toxicology questions and finalized clinical protocols, will then be
prepared and submitted for a Type B meeting with the FDA (Aim 3). Lastly, based on the FDA guidance obtained
in Aim 3, initial tolerability and pK of GneX12 in non-human primates is established and IND readiness is
assessed (Aim 4) in preparation for an open IND and first-in-man clinical trials. The long-term goal of this project
is to develop a biologic, which when administered in conjunction with antibiotics, will not only enhance disease
clearance but will also induce long-term protective immunity. No similar product currently exists.

## Key facts

- **NIH application ID:** 10155414
- **Project number:** 5R44AI104067-05
- **Recipient organization:** THERAPYX, INC.
- **Principal Investigator:** DOMINICK AUCI
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,000,000
- **Award type:** 5
- **Project period:** 2013-02-01 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10155414

## Citation

> US National Institutes of Health, RePORTER application 10155414, Therapy and Prophylaxis for Genital Tract Infection (5R44AI104067-05). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10155414. Licensed CC0.

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