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Efficient and scalable microfluidic gene delivery to hematopoietic stem cells to treat blood diseases

Award Number: R44HL149598
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/15/2019
PERIOD OF PERFORMANCE END DATE: 06/30/2024

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Efficient and scalable microfluidic gene delivery to hematopoietic stem cells to treat blood diseases - Abstract The two dominant methods for delivering genome modifying molecules to cells for cell therapies, viral transduction and electroporation transfection, have process and technical limitations that hamper the development of cutting-edge cell therapies accessible to all. While viral vectors result in a high cost of goods with significant regulatory and health risks associated with manufacturing, electroporation results in unhealthy cells with low viability and off-target phenotype changes. CellFE’s microfluidic VECT technology enables cell transfections with high transfection efficiency, low off-target changes to the cell, and with an expanded cell processing range. This project aims to demonstrate the first commercial cell transfection platform designed for scalable ex vivo genetic modification of CD34+ hematopoietic stem/progenitor cells (HSPC) to develop treatments of genetic and infectious diseases including beta thalassemia, sickle cell disease, hemophilia, and HIV. Scalability means that process parameters used in the research and development phase of cell engineering will immediately apply to clinical scale (300-fold increase in number of processed cells) by simply exchanging a chip. A simpler manufacturing scale-up means a faster path to clinical testing and will be a significant value proposition for the technology. To achieve these goals, CellFE will pursue the following aims: (1) determine the optimal design to scaleup device channels for high-throughput, (2) transfer device fabrication from PDMS to injection molded plastic, (3) demonstrate genetic modification of a therapeutic gene at bench-top at a clinical processing rate, and (4) develop alpha prototype systems for testing in the labs of our pharmaceutical partners to generate paid pilot studies. These are the key technical aims of the SBIR Phase II project and are also the main milestones CellFE needs to accomplish in order to execute its business plan of developing, marketing, and selling cell transfection platforms for cell therapy manufacturing with the prospect to de-risk manufacturing development and reduce cost of goods versus current delivery techniques.


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	2023	CELLFE, INC	1000 ATLANTIC AVE STE 104	ALAMEDA	CA	94501	ALAMEDA	USA	Blood Diseases and Resources Research	000	3	11/25/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $843,224 )
2023	2023	CELLFE INC	980 ATLANTIC AVE	ALAMEDA	CA	94501	ALAMEDA	USA	Blood Diseases and Resources Research	000	3	7/28/2023	NON-COMPETING CONTINUATION	$843,224
														Subtotal = $843,224

Issue Date FY: 2022 ( Subtotal = $837,232 )
2022	2022	CELLFE INC	980 ATLANTIC AVE	ALAMEDA	CA	94501	ALAMEDA	USA	Blood Diseases and Resources Research	000	2	6/30/2022	COMPETING CONTINUATION	$837,232
														Subtotal = $837,232

Grand Total All Awards = $1,680,456

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Efficient and scalable microfluidic gene delivery to hematopoietic stem cells to treat blood diseases

Award Number: R44HL149598

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/15/2019

PERIOD OF PERFORMANCE END DATE: 06/30/2024

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