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Extremely long tumor retention, on-demand releasing Nano-Taxel for eradicating ovarian cancers

Award Number: R44CA228645
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/19/2018
PERIOD OF PERFORMANCE END DATE: 02/29/2024

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Extremely long tumor retention, on-demand releasing Nano-Taxel for eradicating ovarian cancers - Treatment of late-stage ovarian cancer remains one of the greatest challenges for gynecologic oncologists. The clinical efficacy of paclitaxel (PTX), a first-line chemotherapy, is limited due to its severe adverse effect and poor drug exposure and delivery to target tissues. Abraxane® (Albumin-bound paclitaxel, particle size ~130 nm) was designed to overcome the dose-limiting toxicity of standard PTX. However, Abraxane® does not function as a true nanoparticle, because the control over drug properties, such as release rates, is not possible with this formulation. The safety and effectiveness of Abraxane® in ovarian cancer patients have not been established. New nanocarriers able to minimize the premature drug release in blood circulation while releasing drug on-demand at tumor site have profound impact on the improvement of the efficacy and toxicity profile of the chemotherapeutic drugs. It has also been reported that smaller nanoparticles such as 30 nm micelles could penetrate poorly permeable tumors for a better anti-tumor effect. The smart PTX loaded micellar nanoparticles (Nano-Taxel) with smaller size (~20 nm), extremely long tumor retention (at least 12 days), and on-demand drug releasing properties to be developed in this proposal may offer better efficacy and toxicity profile against ovarian cancer, therefore have great commercial potentials to lead to a marketable PTX-nanoformulation for the treatment of ovarian cancer. The overall goal of this proposal is to develop highly effective and less toxic micellar formulation of PTX (Nano-Taxel) against ovarian cancer in preclinical animal models in Phase I studies, and perform current good manufacturing practice (cGMP) production & IND-enabling pharmacology and toxicology studies in Phase II studies that will eventually lead to an IND filing to the FDA for a first-inhuman phase I clinical trial. Our hypotheses are: (i) The smaller and extremely long tumor retention micelle formulation of PTX, compared to its free form are more efficacious and less toxic against ovarian cancer; (ii) The on-demand drug releasing properties of Nano-Taxel achieved by boronate crosslinking strategy will minimize the premature drug release during circulation but allow instant drug release at tumor sites or in tumor cells, therefore will greatly improve the efficacy and toxicity profile; and (iii) OA02, a highly potent targeting ligand, when decorated on the surface of Nano-Taxel to facilitate the in vivo delivery to ovarian cancer, will further improve its therapeutic index. State-of-the-art design of nanocarriers via engineering telodendrimers with well-defined structures represents the frontier development of the nanomedicine, in terms of ease of largescale production, fine-tunable and highly reproducible structure and properties. It will address many translational barriers of nanotherapeutic agents. The use of boronate crosslinked micelles with extremely long tumor retention and on-demand drug releasing properties to delivery PTX to ovarian cancer is highly innovative. It’s an excellent approach to prevent pre-mature drug release during circulation and deliver high concentrations of drug to tumors. It is expected that this research will lead to new approach for ovarian cancer therapy.


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: 2024 ( Subtotal = $0 )
2024	2020	THERANOSTEC INC	5416 BRANINBURG CT	CARMICHAEL	CA	95608	SACRAMENTO	USA	Cancer Detection and Diagnosis Research	000	3	6/18/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2020	THERANOSTEC INC	5416 BRANINBURG CT	CARMICHAEL	CA	95608	SACRAMENTO	USA	Cancer Detection and Diagnosis Research	000	3	9/19/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2020	THERANOSTEC INC	9944 NESTLING CIR	ELK GROVE	CA	95757	SACRAMENTO	USA	Cancer Detection and Diagnosis Research	000	3	8/1/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $1,496,599 )
2020	2020	THERANOSTEC INC	9944 NESTLING CIR	ELK GROVE	CA	95757	SACRAMENTO	USA	Cancer Detection and Diagnosis Research	001	3	8/14/2020	NON-COMPETING CONTINUATION	$1,496,599
2020	2018	THERANOSTEC INC	9944 NESTLING CIR	ELK GROVE	CA	95757	SACRAMENTO	USA	Cancer Detection and Diagnosis Research	000	1	8/12/2020	NEW	$0
														Subtotal = $1,496,599

Issue Date FY: 2019 ( Subtotal = $503,046 )
2019	2019	THERANOSTEC INC	9944 NESTLING CIR	ELK GROVE	CA	95757	SACRAMENTO	USA	Cancer Detection and Diagnosis Research	001	2	8/27/2019	EXTENSION WITH OR WITHOUT FUNDS	$503,046
2019	2018	THERANOSTEC INC	9944 NESTLING CIR	ELK GROVE	CA	95757	SACRAMENTO	USA	Cancer Detection and Diagnosis Research	000	1	11/9/2018	NEW	$0
														Subtotal = $503,046

Issue Date FY: 2018 ( Subtotal = $291,894 )
2018	2018	THERANOSTEC INC	9944 NESTLING CIR	ELK GROVE	CA	95757	SACRAMENTO	USA	Cancer Detection and Diagnosis Research	000	1	8/30/2018	NEW	$291,894
														Subtotal = $291,894

Grand Total All Awards = $2,291,539

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Extremely long tumor retention, on-demand releasing Nano-Taxel for eradicating ovarian cancers

Award Number: R44CA228645

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/19/2018

PERIOD OF PERFORMANCE END DATE: 02/29/2024

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