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Rapid Non-Viral Platform for Generation of Genetically Modified T Cells for Therapy

Award Number: R44CA233143
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/06/2018
PERIOD OF PERFORMANCE END DATE: 05/31/2021

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Rapid Non-Viral Platform for Generation of Genetically Modified T Cells for Therapy - Cancer immunotherapy, particularly genetically engineered adoptive T cell transfer, has shown great potential for the treatment of cancer patients. The use of T cells engineered to express a specific T cell receptor (TCRs) or chimeric antigen receptor (CARs) to treat cancer has generated durable cures for many cancer patients and has resulted in the first FDA approved CAR-T therapy to treat childhood acute lymphoblastic leukemia in 2017. Most gene therapies rely on viral methods to genetically modify human primary cells. However, viral delivery method is expensive, poorly reproducible and associated with several safety concerns including insertion in or near genes that may cause malignancy and generation of replication competent virus. Thus, non-viral DNA delivery methods, such as Sleeping Beauty and piggyBac, have been employed to generate CAR T cells. Although these non-viral delivery methods have the advantage of lower cost, immunogenicity, and regulatory considerations, they have been limited by their low transposition efficiency in primary human hematopoietic cells. In this application, we propose to rationally optimize a recently discovered transposon, TcBuster to deliver CARs to T cells. To this end, we further enhance our already very active hyperactive mutants of the TcBuster transposase and optimize the delivery of the transposon into cells. Following optimization of the TcBuster transposon system, we will combine these improvements with our proprietary methods to transfect T-cells efficiently and safely, and test the immunotherapeutic effectiveness of TcBuster delivered CAR into T cells. The successful completion of this project will result in the comprehensive methods to produce CAR T cells delivered by TcBuster which we will license to pharmaceutical companies to produce highly efficient CAR-T immunotherapy. More broadly, these methods could be expanded beyond immunotherapeutic cancer applications to various infectious diseases in which gene delivery by TcBuster in T cells could be advantageous.


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: 2023 ( Subtotal = -$6,923 )
2023	2020	RESEARCH AND DIAGNOSTIC SYSTEMS, INC.	614 MCKINLEY PL NE	MINNEAPOLIS	MN	55413	HENNEPIN	USA	Cancer Biology Research	000	3	2/2/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	-$6,923
														Subtotal = -$6,923

Issue Date FY: 2022 ( Subtotal = -$26 )
2022	2019	B-MOGEN BIOTECHNOLOGIES INC	1621 E HENNEPIN AVE SUITE B-15	MINNEAPOLIS	MN	55414	HENNEPIN	USA	Cancer Biology Research	000	2	6/29/2022	EXTENSION WITH OR WITHOUT FUNDS	-$26
														Subtotal = -$26

Issue Date FY: 2020 ( Subtotal = $314,418 )
2020	2020	RESEARCH AND DIAGNOSTIC SYSTEMS, INC.	614 MCKINLEY PL NE	MINNEAPOLIS	MN	55413	HENNEPIN	USA	Cancer Biology Research	001	3	8/12/2020	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$314,418
2020	2019	B-MOGEN BIOTECHNOLOGIES INC	1621 E HENNEPIN AVE SUITE B-15	MINNEAPOLIS	MN	55414	HENNEPIN	USA	Cancer Biology Research	000	2	8/12/2020	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $314,418

Issue Date FY: 2019 ( Subtotal = $1,091,666 )
2019	2019	B-MOGEN BIOTECHNOLOGIES INC	1621 E HENNEPIN AVE SUITE B-15	MINNEAPOLIS	MN	55414	HENNEPIN	USA	Cancer Biology Research	001	2	6/5/2019	EXTENSION WITH OR WITHOUT FUNDS	$1,091,666
2019	2018	B-MOGEN BIOTECHNOLOGIES INC	1621 E HENNEPIN AVE SUITE B-15	MINNEAPOLIS	MN	55414	HENNEPIN	USA	Cancer Biology Research	000	1	5/17/2019	NEW	$0
														Subtotal = $1,091,666

Issue Date FY: 2018 ( Subtotal = $218,588 )
2018	2018	B-MOGEN BIOTECHNOLOGIES INC	614 MCKINLEY PL NE	MINNEAPOLIS	MN	55413	HENNEPIN	USA	Cancer Biology Research	000	1	8/6/2018	NEW	$218,588
														Subtotal = $218,588

Grand Total All Awards = $1,617,723

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Rapid Non-Viral Platform for Generation of Genetically Modified T Cells for Therapy

Award Number: R44CA233143

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/06/2018

PERIOD OF PERFORMANCE END DATE: 05/31/2021

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