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Transformable Theranostics for imaging-guided interventions in head and neck squamous cell carcinoma

Award Number: R44CA240068
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2019
PERIOD OF PERFORMANCE END DATE: 02/28/2026

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Transformable Theranostics for imaging-guided interventions in head and neck squamous cell carcinoma - Title: Transformable Theranostics for imaging-guided interventions in head and neck squamous cell carcinoma Summary/Abstract The overall goal of this Phase II SBIR proposal is to translate our highly effective and non-toxic Transformable Nano-Theranostics (TNTs) into clinical trials for precision image-guided intervention of head and neck squamous cell carcinoma (HNSCC). HNSCC is the sixth most common cancer worldwide. There are around 550,000 new cases worldwide annually and 65,630 cases in the U.S. alone. The overall survival rate of HNSCC remains unchanged over the past 25 years. Tumor recurrence and metastasis are the leading causes of mortality. Patients with recurrent or metastatic HNSCC have a median overall survival of only 10 months. Even with intensive surgery, radiotherapy and chemotherapy, prognosis for these patients is still dismal. Complete surgical removal (with negative margins) is the goal of the treatment, but can be difficult to achieve due to the infiltration of vital structures. Since positive surgery margin is associated with poor prognosis, there is a great need to develop novel treatments which can not only guide surgery but also destroy any residual cancer while sparing critical organ structure and function. Moreover, development of theranostic agents that can detect and eliminate early HNSCC lesions, particularly aggressive sub-types, could have tremendous impact in survival and function for many patients. We recently developed a set of highly innovative TNTs that possess outstanding capability to circumvent the sequential biological barriers which have generally hindered drug delivery to tumors, including HNSCC. In our Phase I SBIR grant, we have optimized TNTs and demonstrated that 1) the smart dual size/charge- transformation of TNTs in response to ubiquitous hallmarks of tumors (e.g. tumor acidosis induced acidic extracellular pH, pHe) dramatically increased the tumor accumulation and penetration of TNTs in HNSCC tissue, and facilitated uptake in cancer cells; 2) TNTs enabled effective visualization of tumor, drug delivery and therapeutic effect by near infrared fluorescence imaging (NIRFI) and magnetic resonance imaging (MRI); 3) the synergistic trimodal therapy via TNTs achieved a 100% complete cure rate in orthotopic HNSCC mouse models. Those promising results built a solid foundation for us to move forward to the SBIR Phase II project, in which we plan to 1) synthesize large scale Good Manufactory Production (GMP) grade TNTs, 2) perform Investigation New Drug (IND) enabling pharmacology and toxicology studies in two species (dog and rodent), and 3) draft IND application and design a phase I first-in-human clinical trial for HNSCC patients to determine the dose for phase II. Our long-term goal is to develop safe, highly efficacious and cost-effective theranostic agents for human HNSCC. The successful completion of this research will make the proposed TNTs ready for clinical trials. The proposed transformable, tumor hallmark targeting yet easy-to-make nano-theranostic agents that are highly capable of overcoming the important barriers for drug delivery to HNSCC offer tremendous opportunities for precision image-guided intervention of HNSCC, therefore have great pharmacological, clinical and commercial potentials to lead to a marketable nano-formulation to improve the treatment of HNSCC.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	THERANOSTEC INC	5416 BRANINBURG CT	CARMICHAEL	CA	95608	SACRAMENTO	USA	Cancer Treatment Research	000	4	3/21/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $719,958 )
2024	2024	THERANOSTEC INC	5416 BRANINBURG CT	CARMICHAEL	CA	95608	SACRAMENTO	USA	Cancer Treatment Research	000	4	2/27/2024	NON-COMPETING CONTINUATION	$719,958
														Subtotal = $719,958

Issue Date FY: 2023 ( Subtotal = $849,788 )
2023	2023	THERANOSTEC INC	5416 BRANINBURG CT	CARMICHAEL	CA	95608	SACRAMENTO	USA	Cancer Treatment Research	000	3	4/18/2023	NON-COMPETING CONTINUATION	$849,788
														Subtotal = $849,788

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	THERANOSTEC INC	9944 NESTLING CIR	ELK GROVE	CA	95757	SACRAMENTO	USA	Cancer Treatment Research	000	2	8/31/2022	COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $480,254 )
2021	2021	THERANOSTEC INC	9944 NESTLING CIR	ELK GROVE	CA	95757	SACRAMENTO	USA	Cancer Treatment Research	000	2	8/10/2021	COMPETING CONTINUATION	$480,254
														Subtotal = $480,254

Grand Total All Awards = $2,050,000

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Transformable Theranostics for imaging-guided interventions in head and neck squamous cell carcinoma

Award Number: R44CA240068

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2019

PERIOD OF PERFORMANCE END DATE: 02/28/2026

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