Saturday, August 9, 2025 8/9/2025

Encapsulated anti-IL-10 for the immune therapy of gonorrhea infection

Award Number: R43AI147718
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2019
PERIOD OF PERFORMANCE END DATE: 07/31/2021

Group Awards By:

View Award Description

Encapsulated anti-IL-10 for the immune therapy of gonorrhea infection - ABSTRACT Gonorrhea is a genital tract infection caused by Neisseria gonorrhoeae. It does not induce a state of specific protective immunity and can be acquired repeatedly. Despite public health measures, gonorrhea persists at an unacceptably high frequency, and there is no vaccine against it. The continued emergence of antibiotic resistance threatens to render gonorrhea untreatable. Our findings have revealed that N. gonorrhoeae subverts the immune system for its own benefit by inducing high levels of the key immunosuppressive cytokine, interleukin-10 (IL-10). Using a mouse model of vaginal gonococcal infection, our preliminary data suggests a novel strategy of immune based therapy aimed at reversing the immunosuppression induced by N. gonorrhoeae. Neutralizing antibody against IL-10 has been encapsulated in biodegradable micro-particles for local sustained release to create a proprietary product designated GneXa10®. Intra-vaginal administration of GneXa10® in mice with genital gonococcal infection induces T-cell and antibody responses against N. gonorrhoeae, which accelerate clearance of the existing infection and generate resistance to re-infection with both homologous and heterologous strains. Advantages of this treatment include minimal inflammatory potential in the female reproductive tract. In this phase I application, the dose regimen of GneXa10® will be optimized. Initial mechanistic studies related to the role of B cells and duration of protection will be performed. We will also test the ability of GneXa10® to induce protection against re infection in the clinically and commercially relevant context of treatment with antibiotics. This work will provide proof-of-principle and the scientific underpinnings for GneXa10®. Future SBIR phase II studies will further elucidate cross-protection and validate the expected applicability of scaled-up encapsulation methods to anti-IL-10 antibody, evaluating yield, bioactivity, batch-to-batch consistency and shelf stability. The CDC has listed drug-resistant N. gonorrhoeae as “an immediate public health threat that requires urgent and aggressive action”, and WHO has called for “the creation and development of new therapeutic options”. This proposal is part of our company’s response to that call to action.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2019	THERAPYX,INC	2468 GRINSTEAD DR	LOUISVILLE	KY	40204	JEFFERSON	USA	Allergy and Infectious Diseases Research	000	1	11/11/2021	NEW	-$239,162
2022	2019	THERAPYX,INC	2468 GRINSTEAD DR	LOUISVILLE	KY	40204	JEFFERSON	USA	Allergy and Infectious Diseases Research	001	1	2/10/2022	NEW	$239,162
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $239,162 )
2019	2019	THERAPYX,INC	2468 GRINSTEAD DR	LOUISVILLE	KY	40204	JEFFERSON	USA	Allergy and Infectious Diseases Research	000	1	7/31/2019	NEW	$239,162
														Subtotal = $239,162

Grand Total All Awards = $239,162

Top

All Categories

About

Search

Reports

Data Submission

Award Information

Encapsulated anti-IL-10 for the immune therapy of gonorrhea infection

Award Number: R43AI147718

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 08/01/2019

PERIOD OF PERFORMANCE END DATE: 07/31/2021

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer