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Path to Commercialization of the first ?off the shelf? T cell product

Award Number: R44HL132348
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/15/2017
PERIOD OF PERFORMANCE END DATE: 03/31/2021

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Path to Commercialization of the first ?off the shelf? T cell product - ABSTRACT The adoptive transfer of virus-specific T cells has produced remarkable clinical results in patients with viral disease. However, broader implementation of this therapy has been limited by the (i) prohibitive production costs, (ii) complexity of manufacture, (iii) prolonged time for preparation and product release, and (iv) the requirement for individualized, patient-specific products. Over the past 6 years we have systematically addressed these problems: we simplified and refined our manufacturing technology, removed biohazardous components and employed a new cell expansion platform using a gas permeable culture device which promotes the proliferation and survival of large cell numbers in a GMP-compliant closed system with minimal technician intervention. Finally, we have established the clinical benefit associated with the infusion of partially HLA matched virus-specific T cells that are prospectively generated and banked, making them available for immediate “off the shelf” use. Thus, with the purpose of moving beyond highly specialized academic centers we established a Baylor College of Medicine-affiliated company called ViraCyte with the goal of commercializing “off the shelf” virus- specific T cells. Our product - Viralym-B - is a bank of T cell lines with specificity for BK virus, which, in immunocompromised individuals including children, is responsible for severe clinical syndromes like hemorragic cystitis and nephropathy that can lead to significant morbidity and prolonged hospital stay. Our therapy is intended for the treatment of drug-resistant infections/disease, a condition that afflicts less than 200,000 persons in the United States and for which there is no standard of care. Thus, in the current application we will test the safety and potential for anti-viral activity of Viralym-B in allogeneic hematopoietic stem cell transplant recipients. In addition, we will further de-risk the transfer of this technology to a private sector contract manufacturing organization (CMO) by transitioning our cell production from an open to an entirely closed system and validating our scale-up manufacture protocol. Success of this application will lay the foundation for a Phase IIb study to confirm the efficacy of “off the shelf” Viralym-B cells and facilitate market approval, thereby moving T cell therapy for BK virus into the public domain as a standard of care.


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: 2022 ( Subtotal = $0 )
2022	2019	ALLOVIR, INC.	139 MAIN ST STE 500	CAMBRIDGE	MA	02142	MIDDLESEX	USA	Blood Diseases and Resources Research	000	8	10/28/2021	NON-COMPETING CONTINUATION	$0
2022	2019	ALLOVIR, INC.	139 MAIN ST STE 500	CAMBRIDGE	MA	02142	MIDDLESEX	USA	Blood Diseases and Resources Research	001	8	11/4/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2019	ALLOVIR, INC.	2925 RICHMOND AVE STE 1274	HOUSTON	TX	77098	HARRIS	USA	Blood Diseases and Resources Research	000	8	4/28/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $1,022,567 )
2019	2019	VIRACYTE, INC.	2925 RICHMOND AVE STE 1274	HOUSTON	TX	77098	HARRIS	USA	Blood Diseases and Resources Research	000	8	3/11/2019	NON-COMPETING CONTINUATION	$1,022,567
														Subtotal = $1,022,567

Issue Date FY: 2018 ( Subtotal = $986,769 )
2018	2018	VIRACYTE, LLC	33 5TH AVE NW STE 800	NEW BRIGHTON	MN	55112	RAMSEY	USA	Blood Diseases and Resources Research	001	7	7/19/2018	NON-COMPETING CONTINUATION	$0
2018	2018	VIRACYTE, LLC	33 5TH AVE NW STE 800	NEW BRIGHTON	MN	55112	RAMSEY	USA	Blood Diseases and Resources Research	000	7	4/1/2018	NON-COMPETING CONTINUATION	$986,769
														Subtotal = $986,769

Issue Date FY: 2017 ( Subtotal = $988,677 )
2017	2017	VIRACYTE, LLC	33 5TH AVE NW STE 800	NEW BRIGHTON	MN	55112	RAMSEY	USA	Blood Diseases and Resources Research	000	6	6/12/2017	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$988,677
														Subtotal = $988,677

Grand Total All Awards = $2,998,013

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Path to Commercialization of the first ?off the shelf? T cell product

Award Number: R44HL132348

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 06/15/2017

PERIOD OF PERFORMANCE END DATE: 03/31/2021

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