You are here

Fully Human Antibodies for the Prevention of Respiratory Syncytial Virus

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41AI140945-01A1
Agency Tracking Number: R41AI140945
Amount: $300,000.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NIAID
Solicitation Number: PA18-575
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-09-05
Award End Date (Contract End Date): 2021-02-28
Small Business Information
2101 20TH AVE S
Nashville, TN 37212-4311
United States
DUNS: 080864272
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (410) 350-4757
Business Contact
Phone: (615) 343-8064
Research Institution
1161 21ST AVE S, STE D3300 MCN
NASHVILLE, TN 37232-0011
United States

 Domestic Nonprofit Research Organization

The goal of this STTR is to provide a preclinically validated monoclonal antibody or antibody combination for the prevention of respiratory syncytial virusRSVin high risk patients including infants and the elderlyWorldwideof children are infected with RSV before the age ofresulting in an estimatedmillion lower respiratory tract infectionsIn the United States adults overhavemillion RSV infections causinghospitalizations and overdeathsDespite the immense impact of RSV on these high risk populationswe lack effective preventative modalitiesRecent technological advances in monoclonal antibody discovery and manufacturing have led to increased interest in using monoclonal antibodies as prophylactics for infectious diseasesIn collaboration with the Crowe lab at Vanderbilt University Medical Centerwe have identified several monoclonal antibodies that have high potential to outperform the current standard of care and expand preventative options to other populations with unmet needsIn this Phase I STTRwe seek to identify promising antibody combinationsevaluate in vivo efficacyand optimize the manufacturability of our lead anti RSV monoclonal antibody candidateso that we can continue to advance preclinical development in Phase IITo accomplish thiswe propose the following AimsAimIdentify the optimal combination of human RSV mAbs for protectionBroad clinical introduction of a preventative antibody carries risk of emergence of resistant RSV virusesTo address this potential problemwe will assess binding and functional performance of diverse anti RSV antibody combinations for prevention of escape mutations and for synergistic neutralizationfollowed by selection of thehighest performing antibody combinationsAimDetermine in vivo efficacy of anti RSV mAb candidates and select leadWe will place theanti RSV antibodies or combinations in cotton rats to assess in vivo efficacyBased on in vitro and cotton rat studieswe will select a single or combination lead candidateAimAssess manufacturing computational liability and identify candidate siblings with optimized performance and manufacturing computational liabilityWe have an in silico tool for assessment of manufacturing computational liabilities of the lead candidateWe have unique analytic capabilities and access to the data from the Human Immunome ProjectHIPUsing the HIP data and the in silico assessment tool we can identify naturally occurring siblings with superior manufacturability profiles than our original anti RSV mAb candidatesWe will then perform high throughput binding and neutralization assays to assess performance followed by selection of the optimized lead antibody productAt the end of this Phase I STTRwe will have selected a single optimized lead anti RSV antibody or combinationWe will be poised to launch Phase IIin which we will pursue preclinical development of this lead with the ultimate goal of developing a product that fulfills the unmet need of preventing RSV in high risk patients IDBiologics proposes to develop a prevention for Respiratory Syncytial VirusRSVAlthough RSV produces simple cold like symptoms in most peopleinfants and the elderly are at risk for a more severe and dangerous form of the diseaseTaking a page from the human immune systemwe are using monoclonal antibodies to attack RSVby using the latest information about the virus and the latest technologies in antibody engineering

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

US Flag An Official Website of the United States Government