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STING Activators as Therapy for Cancer

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R42CA250629-02A1
Agency Tracking Number: R42CA250629
Amount: $1,987,099.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: 102
Solicitation Number: PA21-261
Solicitation Year: 2021
Award Year: 2022
Award Start Date (Proposal Award Date): 2022-09-22
Award End Date (Contract End Date): 2024-08-31
Small Business Information
1951 NW 7TH AVE STE 600
Miami, FL 33136-1128
United States
DUNS: 002058614
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (305) 646-8103
Business Contact
Phone: (305) 243-3808
Research Institution
CORAL GABLES, FL 33146-2926
United States

 Nonprofit College or University

The Immuno-oncology (IO) arena affords a new and exciting approach to stimulate the body’s own immune
system to fight cancer. The generation of anti-cancer T cells is predominantly triggered by phagocytosed cancer
cells stimulating innate immune signaling pathways in professional antigen presenting cells (APC’s). This
signaling process is largely governed by STING (stimulator of interferon genes), a cellular protein discovered by
the laboratory of Dr. Glen N. Barber that plays an essential role in host defense against infectious disease and
cancer. Activation of STING triggers cytokine production and facilitates tumor antigen cross-presentation.
Indeed, considerable effort is now underway in the biotech arena to discover techniques to augment STING
activity with the objective of invigorating the generation of anti-tumor cytotoxic T cells. Along with check-point
inhibitors and CAR-T cell therapy, the plausible utilization of STING agonists affords a new, complementary
immunotherapeutic strategy to treat malignant disease.
Here, STINGINN, LLC (“STINGINN”), in collaboration with the University of Miami, proposes to perform an FDA
approved investigator sponsored small Phase I clinical trial for patients suffering from highly aggressive
leukemias, specifically relapsed/refractory acute myeloid leukemia (AML) and adult lymphocytic leukemia (ALL)
focusing on HTLV-1 associated adult T cell lymphocytic leukemia (ATLL). Our strategy involves reinfusing
autologous tumor cells loaded with STING-dependent adjuvants (STAVs) into patients to stimulate APCs in vivo
and thus anti-tumor CTL’s. Our pre-clinical data indicates that STAV loaded cells are highly immunogenic, potent
activators of APC’s. We have already submitted an IND FDA application based on this work and have assembled
an appropriate team to carry out the proposed trial. Our proposal is also applicable to a variety of cancers, not
just leukemia, providing the opportunity to initiate a number of alternate cancer therapeutic trials in the future.

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

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