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Anaerobic Manufacturing and Molecular Analytical Process Optimization to Support Clinical Development of Live Biotherapeutic Products

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R44AI170366-01
Agency Tracking Number: R44AI170366
Amount: $1,972,299.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA21-259
Timeline
Solicitation Year: 2021
Award Year: 2022
Award Start Date (Proposal Award Date): 2022-02-04
Award End Date (Contract End Date): 2025-01-31
Small Business Information
930 Brittan Avenue
San Carlos, CA 94070
United States
DUNS: 072682331
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 RICARDO VALLADARES
 (415) 991-0947
 rvalladares@sioltatherapeutics.com
Business Contact
 RICARDO VALLADARES
Phone: (415) 991-0947
Email: rvalladares@sioltatherapeutics.com
Research Institution
N/A
Abstract

ABSTRACT
Allergic diseases including atopic dermatitis, food allergy, and allergic asthma represent a global health problem
that disproportionately impacts children. Surprisingly, there are no approved approaches to prevent the
development of these diseases in at-risk individuals, resulting in chronic morbidity and economic burden. The
management of asthma, for example, carries a steep cost burden of billions of dollars per year in the US alone,
of which nearly 20 billion is spent on standard of care treatments with variable efficacy. Food allergy management
is generally limited to allergen avoidance and rescue from severe acute anaphylaxis. There is a crucial need to
develop innovative strategies to prevent the onset of these Type 1 allergic diseases rather than treating their
symptoms. A preventative approach targeting at-risk individuals could significantly reduce the morbidity and
healthcare burden associated with these increasingly common conditions.
Studies confirm the link between gut microbiota development, immunological training, and allergic disease onset
in childhood, and it is now clear that allergic disease risk is associated with aberrant microbial exposures over
the first year of life. Longitudinal gut microbiota profiling studies in infants and children show that a loss of specific
immunomodulatory commensal bacteria, and their metabolic networks, precedes allergic disease development.
Using infant gut microbiota data sets and in vivo allergic disease models, Siolta Therapeutics has designed a
live biotherapeutic product (LBP), STMC-103H, to stimulate tolerant immunological development and prevent
allergic disease onset in at-risk individuals. STMC-103H contains three distinct active ingredient bacteria isolated
from healthy human stool. Siolta has performed extensive cGMP manufacturing development, including
formulation, process, and analytical method development, to support Phase 1 and Phase 2 clinical trials of
STMC-103H under an IND with the FDA.
In this project, we will build on our previous STMC-103H drug product development to improve the stability,
potency, and characterization approaches for late-stage clinical trials and subsequent commercialization.
Success of this project will directly support the regulatory and commercial development of STMC-103H.
Indirectly, this work will improve the manufacturing and clinical development of diverse candidate LBPs
containing sensitive live bacteria with high therapeutic potential. Siolta will also seek to license novel
manufacturing approaches to other LBP developers.

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

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