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Preclinical development of a biological antiviral for universal influenza treatment and prophylaxis using a novel nucleic acid delivery platform

Award Number: R44AI140243
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/20/2018
PERIOD OF PERFORMANCE END DATE: 03/31/2024

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Preclinical development of a biological antiviral for universal influenza treatment and prophylaxis using a novel nucleic acid delivery platform - The goal of this project is to advance the development of a novel biologic antiviral (SiVEC-IAV™) against human influenza. Influenza is a worldwide public health problem that infects approximately 20% of the U.S. population annually and is associated with an annual economic burden of over $11 billion USD. Although currently available influenza vaccines and antivirals are practical approaches to prevent and treat influenza, the efficacy of all available products is suboptimal and they are contraindicated for many patients. To meet the need for new approaches to prevent and manage influenza, SiVEC Biotechnologies developed a novel biological antiviral. Our core-enabling technology is a versatile nucleic acid delivery platform that is characterized as non-immunogenic, non-pathogenic bacteria. For use as an influenza antiviral (SiVEC-IAV) the bacteria are programmed to constitutively express short hairpin RNA (shRNA) molecules, and target their delivery directly to mucosal epithelial cells, where the RNA interference (RNAi) pathway degrades viral transcripts that are necessary for influenza infection. Phase I studies demonstrated the safety, efficacy, and commercial potential of SiVEC-IAV. Phase II studies will advance SiVEC-IAV through IND-directed and preclinical studies, including optimization of the SiVEC-IAV delivery vehicle (Aim 1); definition of the SiVEC-IAV formulation and preliminary product specifications (Aim 2); and evaluation of SiVEC-IAV in a ferret model of human influenza (Aim 3). The long-term goal is to obtain FDA approval of SiVEC-IAV and make its widespread use possible. We expect that SiVEC-IAV, in combination with annual vaccination and other preventative and treatment measures, will be part of a multimodal approach to reduce the incidence of influenza as well as the cost burden. This unique approach to safely delivering nucleic acids to the appropriate cells and tissues to facilitate a therapeutic effect overcomes multiple barriers associated with the translation of RNAi-based therapeutics into clinical practice. In addition, the SiVEC delivery platform can be tailored to deliver other nucleic acids and gene editing systems to clinically relevant tissues to extend its utility outside the realm of RNAi-based therapeutics.


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	2022	SIVEC BIOTECHNOLOGIES, INC.	1505 W MULBERRY ST	FORT COLLINS	CO	80521	LARIMER	USA	Allergy and Infectious Diseases Research	000	4	10/29/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $1,000,088 )
2022	2022	SIVEC BIOTECHNOLOGIES LLC	1505 W MULBERRY ST	FORT COLLINS	CO	80521	LARIMER	USA	Allergy and Infectious Diseases Research	000	4	5/12/2022	NON-COMPETING CONTINUATION	$1,000,088
														Subtotal = $1,000,088

Issue Date FY: 2021 ( Subtotal = $1,019,722 )
2021	2021	SIVEC BIOTECHNOLOGIES LLC	1505 W MULBERRY ST	FORT COLLINS	CO	80521	LARIMER	USA	Allergy and Infectious Diseases Research	001	3	7/23/2021	NON-COMPETING CONTINUATION	$1,019,722
2021	2020	SIVEC BIOTECHNOLOGIES LLC	1505 W MULBERRY ST	FORT COLLINS	CO	80521	LARIMER	USA	Allergy and Infectious Diseases Research	000	2	5/18/2021	COMPETING CONTINUATION	$0
														Subtotal = $1,019,722

Issue Date FY: 2020 ( Subtotal = $1,028,842 )
2020	2020	SIVEC BIOTECHNOLOGIES LLC	1900 E SEADRIFT DR UNIT A	WINDSOR	CO	80550	WELD	USA	Allergy and Infectious Diseases Research	001	2	7/13/2020	COMPETING CONTINUATION	$28,842
2020	2020	SIVEC BIOTECHNOLOGIES LLC	1900 E SEADRIFT DR UNIT A	WINDSOR	CO	80550	WELD	USA	Allergy and Infectious Diseases Research	000	2	5/11/2020	COMPETING CONTINUATION	$1,000,000
														Subtotal = $1,028,842

Grand Total All Awards = $3,048,652

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Preclinical development of a biological antiviral for universal influenza treatment and prophylaxis using a novel nucleic acid delivery platform

Award Number: R44AI140243

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/20/2018

PERIOD OF PERFORMANCE END DATE: 03/31/2024

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