Topic 374: Sustained Delivery of PARP Inhibitors for Cancer Chemoprevention

Topic 374: Sustained Delivery of PARP Inhibitors for Cancer Chemoprevention

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 75N91018C00026-0-0-0
Agency Tracking Number: N43CA180026
Amount: $300,000.00
Phase: Phase I
Program: SBIR
Awards Year: 2018
Solicitation Year: 2017
Solicitation Topic Code: NCI
Solicitation Number: N/A
Small Business Information
41 Etsy Farm Road, NEWTON, MA, 02459
DUNS: 079591740
HUBZone Owned: N
Woman Owned: Y
Socially and Economically Disadvantaged: N
Principal Investigator
 Bijay Singh
 (617) 755-3838
 theranano@outlook.com
Business Contact
 Bijay Singh
Phone: (617) 755-3838
Email: theranano@outlook.com
Research Institution
N/A
Abstract
Here we propose to study two injectable formulations that provide different delivery routes for Talazoparib, potent PAPR inhibitor: An implant, InCeT-Talazoparib, which can be injected directly in the tumor where it will act as a sustained release depot of Talazoparib over a prolonged period of approximately 30 days. It delivers 100% of the drug to the tumor site with almost no systemic toxicity. It can be used for neoadjuvant chemotherapy or as a breast-preserving alternative to radical mastectomy. Our central hypothesis is that these Talazoparib formulations will enhance tumor drug delivery compared to oral Talazoparib, thereby increasing tumor cell kill and minimizing side-effects in triple-negative breast cancer. To prove this hypothesis, we will study how these formulations behave in the bloodstream, where they end up, and how long they last. The therapeutic efficacy will be assessed in vitro using mutated BC cell lines and in vivo using genetically engineered and orthotopic mouse models. Drug accumulation, uptake, safety, and efficacy at the cell, tissue, and animal level will be compared to conventional oral dosing of Talazoparib. Successful outcome of the proposed studies could lead to Phase I clinical trials for neoadjuvant treatment of BC in 2-3 years. If successfully completed, the project would proffer new treatment options for enhancing therapeutic efficacy, prolonging progression-free survival, reducing mortality, and greatly improving the quality of life for as many as 75% of TNBC patients, and 33% of breast cancer patients overall.

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

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