SBIR-STTR Award

SiNc-NP, an innovative tumor-specific nano medicine for treatment of canine cancers
Award last edited on: 4/12/2023

Sponsored Program
SBIR
Awarding Agency
NIH : FDA
Total Award Amount
$259,613
Award Phase
1
Solicitation Topic Code
103
Principal Investigator
Kyle Gee

Company Information

Therafluor Inc

2636 Terrace View Drive
Eugene, OR 97405
   (541) 517-1757
   N/A
   www.therafluor.com
Location: Single
Congr. District: 04
County: Lane

Phase I

Contract Number: 1R43FD007525-01
Start Date: 9/20/2022    Completed: 8/31/2023
Phase I year
2022
Phase I Amount
$259,613
SiNc-NP, an innovative tumor-specific nano medicine for treatment of canine cancers Canines are prone to the development of cutaneous/subcutaneous cancers with mast cell tumors(MCT) being the most common skin malignancy. Surgical resection is the conventional treatment for canineMCT, but tumor-positive resection margins remain a challenge; resulting in high tumor recurrence ratesespecially for high-grade MCT. What is needed is an effective intraoperative strategy that would not only aidthe veterinary surgeon with margin delineation and metastatic lymph node detection, but also offer an adjuvanttherapy that can be performed immediately following tumor resection to eliminate any residual cancer left in thesurgical bed. Such an intraoperative strategy would improve long-term survival rates for dogs at a significantcost savings to pet owners by reducing the need for expensive follow-up procedures. Towards this goal,TheraFluor is focused on the development and commercialization of our patented tumor-activatable nearinfrared (NIR) theranostic nanomedicine. This smart "all-in-one" nanomedicine comprises imaging andtherapeutic functions, which are integrated into a formulation based on a single agent, silicon naphthalocyanine(SiNc), encapsulated in biodegradable PEG-PCL (poly (ethylene glycol)-b-poly(ɛ-caprolactone)) nanoparticles(SiNc-NP). SiNc-NP offers a number of advantages over established NIR fluorescent imaging agents,including: low background because it fluoresces in the NIR and is formulated to remain "off" until itaccumulates in tumor cells, it has enhanced photo-stability, no significant toxicity or phototoxicity, andpossesses dual PT properties (photodynamic and photothermal therapies). The goal for this Phase Iapplication is to determine the proper dose for SiNc-NP to target MCT both in the mouse syngeneic P815mastocytoma tumor model and in canines. Furthermore, the efficacy of SiNc-enabled PT treatment will betested in the mouse P815 model. The results of these Phase I studies will determine extended canine clinicalstudies, treatment paradigms, and toxicology assessments to pursue during Phase II with the goal of filing anInvestigational New Animal Drug (INAD) with the FDA/CVM for the treatment of canine MCT.

Public Health Relevance Statement:
PROJECT NARRATIVE The primary treatment for canine mast cell tumors (MCT), the most common malignant skin cancer afflicting dogs, is surgical resection of the tumor. Tumor-positive margins, especially with high-grade MCTs, frequently results in primary tumor recurrence and metastasis. Adjuvant therapies that effectively eliminate cancer cells left in the surgical bed would greatly improve outcomes. To overcome this challenge, TheraFluor is focused on the development of our patented tumor-activatable near infrared (NIR) theranostic nanomedicine, SiNc-NP, which possesses both NIR imaging and combinatorial phototherapeutic functions.

Project Terms:

Phase II

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Start Date: 00/00/00    Completed: 00/00/00
Phase II year
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