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Therapeutic Antibody for RSV IIB

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R44AI122360-03
Agency Tracking Number: R44AI122360
Amount: $2,997,704.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: R
Solicitation Number: PA18-574
Timeline
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2018-12-12
Award End Date (Contract End Date): 2021-11-30
Small Business Information
1505 OBRIEN DR # B
Menlo Park, CA 94025-1435
United States
DUNS: 962700048
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 LAWRENCE KAUVAR
 (415) 722-4305
 lkauvar@trellisbio.com
Business Contact
 MILT FRIEDMAN
Phone: (650) 616-1100
Email: miltinno@gmail.com
Research Institution
N/A
Abstract

Abstract
Respiratory syncytial virus (RSV) is a leading cause of serious lower respiratory tract disease in infants, leading
annually to ~200,000 deaths and 3-4 million hospitalizations worldwide. Close to $1 billion has been invested by
the RSV community over the past two decades in clinical trials seeking to improve upon the marketed monoclonal
antibody Synagis®, which is only approved for prophylaxis of very low birth weight premature birth infants. None
of these efforts, which have attacked the same viral protein as Synagis (the F protein), has yielded a new
approved drug or vaccine. Based on insights into the pathology of RSV infection gained over the past ten years
by numerous investigators, Trellis has chosen to target the only other major viral envelope protein (the G protein).
Preclinical data support the expectation of substantially improved activity of Trellis’ monoclonal antibody TRL3D3
as a post-infection therapeutic, thereby addressing major populations not served by Synagis, including full-term
infants, the elderly and immunocompromised patients. With funding from an SBIR Phase II grant, Trellis has
established a commercially-attractive manufacturing process for TRL3D3. In this Phase IIB proposal, we seek
funding to complete the IND-enabling work and initiate production of the first clinical lot. We also propose to
explore the impact in mice of TRL3D3 on biomarkers that may have utility for establishing efficacy trends in early
clinical trials.Narrative
In the US, RSV is responsible for 20% of all hospitalizations for infants and young children, at an estimated cost
of $1B annually, but no effective therapeutic agent has been developed. Trellis has discovered (and patented) a
novel antibody (TRL3D3) with strong preclinical data in treating RSV infection. The work proposed here will
complete the preclinical development needed to gain FDA approval to initiate human clinical testing of the
innovative agent.

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

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