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Delivery of pathogen trapping antibodies for vaginal protection

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41AI122472-01
Agency Tracking Number: R41AI122472
Amount: $272,725.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIAID
Solicitation Number: PA14-072
Solicitation Year: 2014
Award Year: 2016
Award Start Date (Proposal Award Date): 2016-02-10
Award End Date (Contract End Date): 2018-01-31
Small Business Information
Carrboro, NC 27510-2504
United States
DUNS: 079756959
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (410) 337-8377
Business Contact
Phone: (402) 472-0106
Research Institution
CHAPEL HILL, NC 27599-0001
United States

 Nonprofit College or University

DESCRIPTION provided by applicant Despite immense efforts in behavioral interventions to promote safer sexual practices sexually transmitted infections STIs continue to be a pandemic worldwide Unfortunately there are no effective vaccines or microbicides for the majority of STIs A pathogen specific safe effective and discreet vaginal microbicide that does not require daily or sex associated dosing would provide a powerful prevention tool addressing the current gap in behavioral and pharmacological interventions Among different classes of microbicide candidates currently in clinical and pre clinical development human monoclonal antibodies mAb delivered locally to mucosal surfaces offer exceptional promise combining safety effectiveness and unparalleled specificity Adding further to the promise of mAb the Lai and Cone Labs recently discovered a novel antibody function in mucus IgGs that trap individual pathogens in mucus and have pioneered a technology enhancing the use of mAb in mucosal secretions based on carefully tuned affinity between IgG Fc and mucins which will be exclusively licensed to Mucommune We have shown that engineered mAb can trap Herpes viruses in human cervicovaginal mucus CVM with fold greater potency than protection by neutralization More importantly trapping viruses in mucus with vaginally dosed mAb can directly block vaginal Herpes transmission in vivo in the absence of other immune protective functions The Lai Lab has since advanced this technology by showing that specific mAb trap not only viral but also highly motile bacterial pathogens and that pathogen trapping can occur in lung and GI mucus secretions underscoring the universal nature of this novel IgG mucin function and the broad applicability of the Mucommune technology In this Phase I STTR we will build upon our work to demonstrate that pathogen trapping mAb when formulated into sustained release polymeric capsules will remain sufficiently stable upon long term exposure to human mucus secretions and retain its pathogen trapping function i e both pathogen and mucin binding when released into CVM over a day period In Aim we will encapsulate pathogen trapping mAb into polymeric capsules prepared from D printing and characterize the integrity of the mAb before after loading and after release from the polymeric capsules In Aim we will incubate mAb loaded capsules with human CVM and measure the stability and pathogen trapping potency of encapsulated and released mAb in CVM Successful completion of these studies will lead to a Phase II proposal where the overall goal will be to develop a shelf stable vaginal ring with embedded polymeric capsules that slowly release a cocktail of mAb providing effective protection against a broad spectrum of STIs with convenient once a month application By enabling enhanced mAb function in mucus secretions we expect Mucommune will help pave the way for improved molecularly targeted therapies and prophylaxis against a broad spectrum of pathogens and microbes across all major mucosal surfaces PUBLIC HEALTH RELEVANCE The lack of vaccines for many common sexually transmitted infections STIs has resulted in tremendous health and cost burden in the United States and worldwide thus there is an urgent need for alternative methods to block STIs To better protect against STIs Mucommune is developing antibodies engineered to trap pathogens in mucus thereby directly blocking vaginal infections This STTR will establish the feasibility of producing
a multi purpose vaginal ring providing month long delivery of pathogen trapping antibodies against a broad spectrum of STIs

* Information listed above is at the time of submission. *

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