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NV103: Antibody Conjugated Nanoparticle for Ewing Sarcoma Targeted Therapy

Award Number: R44CA233128
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/14/2018
PERIOD OF PERFORMANCE END DATE: 04/30/2021

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NV103: Antibody Conjugated Nanoparticle for Ewing Sarcoma Targeted Therapy - This Phase II SBIR project seeks to demonstrate that novel, targetable nanoparticles can delivery therapeutic substances to human tumor cells and reduce tumor burden in cancer. The concept for these nanoparticles is based on the hybrid polymerized liposome nanoparticle (HPLN) that displays functional antibodies that target tumor cell surface markers. The therapeutic cargos are encapsulated cytotoxic drugs that comprise the front line treatment for Ewing sarcoma. Upon recognition by the tumor cell, the nanoparticle binds, gets taken into the cell (endocytosed) and the nanoparticle cargo is released, ultimately allowing availability of the drug to kill the cancer cell. This project fits well within the mission of the NCI, to develop new nanotechnology-based therapeutics. Treatment-resistant metastases are the ultimate cause of death in most cancer patients. Systemic therapy for metastases is generally ineffective. A reliable, low-toxic, highly effective therapy is urgently needed to treat both relapse patients and treatment-resistant metastases. The specific aims of this proposal are therefore to optimize the HPLN particle, carry out efficient encapsulation of cancer drugs inside the targeted HPLNs, demonstrate safety and efficacy in killing cancer cells in a humanized xenograft mouse model of human Ewing sarcoma. The first aim is to determine the maximal tolerated dose (MTD) in healthy animals and the PK-efficacy relationship in tumor-bearing mice. NanoValent’s goal, at the conclusion of the Phase II is to have an optimized formulation that can be GMP manufactured and subsequently gather the necessary data for an IND submission to the FDA for approval of this novel 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: 2020 ( Subtotal = $892,769 )
2020	2020	NANOVALENT PHARMACEUTICALS, INC.	351 EVERGREEN DR STE B	BOZEMAN	MT	59715	GALLATIN	USA	Cancer Treatment Research	001	3	9/9/2020	NON-COMPETING CONTINUATION	$790
2020	2020	NANOVALENT PHARMACEUTICALS, INC.	351 EVERGREEN DR STE B	BOZEMAN	MT	59715	GALLATIN	USA	Cancer Treatment Research	000	3	4/2/2020	NON-COMPETING CONTINUATION	$891,979
														Subtotal = $892,769

Issue Date FY: 2019 ( Subtotal = $1,019,254 )
2019	2019	NANOVALENT PHARMACEUTICALS, INC.	351 EVERGREEN DR STE B	BOZEMAN	MT	59715	GALLATIN	USA	Cancer Treatment Research	001	2	4/19/2019	EXTENSION WITH OR WITHOUT FUNDS	$1,019,254
2019	2018	NANOVALENT PHARMACEUTICALS, INC.	351 EVERGREEN DR STE B	BOZEMAN	MT	59715	GALLATIN	USA	Cancer Treatment Research	000	1	4/19/2019	NEW	$0
														Subtotal = $1,019,254

Issue Date FY: 2018 ( Subtotal = $240,749 )
2018	2018	NANOVALENT PHARMACEUTICALS, INC.	910 TECHNOLOGY BLVD STE G	BOZEMAN	MT	59718	GALLATIN	USA	Cancer Treatment Research	000	1	9/14/2018	NEW	$240,749
														Subtotal = $240,749

Grand Total All Awards = $2,152,772

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NV103: Antibody Conjugated Nanoparticle for Ewing Sarcoma Targeted Therapy

Award Number: R44CA233128

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/14/2018

PERIOD OF PERFORMANCE END DATE: 04/30/2021

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