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Universal Influenza A/B Vaccine

Award Number: R44AI153011
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: 08/07/2020
PERIOD OF PERFORMANCE END DATE: 04/30/2026

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Universal Influenza A/B Vaccine - Abstract Universal influenza vaccines should be possible if conserved antigens of influenza are effectively targeted and effective antiviral immune responses are generated against those antigens. DNA vaccination is an appealing approach for delivering universal influenza vaccines, however, natural immune responses to conserved influenza antigens are typically weak and most DNA vaccines tested in humans have not elicited robust humoral immunity. To overcome the obstacles to developing universal influenza DNA vaccines, we are using novel composite immunogens and delivering them with a next generation Gene Gun device that combines several engineering and formulation innovations that increase immunogenicity by increasing the number of skin cells and antigen presenting cells expressing vaccine antigen. We have already obtained encouraging results with a universal influenza A (UFluA) DNA vaccine. Under this SBIR proposal, we intend to test a companion universal influenza B (UFluB) DNA vaccine to create a more comprehensive universal A/B vaccine (UFluA/B) that will provide broad protective coverage from all influenza A and B types capable of infecting humans. If we are successful at demonstrating that a single UFluA/B DNA vaccine can induce broad responses and protection in mice in the phase I effort, we will advance this this product to preclinical testing under the phase II portion of this application where we will investigate immunogenicity and protective efficacy in naïve and pre-immune ferrets and safety and efficacy in a nonhuman primate model that closely resembles humans in their dosing, immune response to DNA vaccination and susceptibility to influenza. If successful, these data will provide Orlance with a strong preclinical IND data package to advance this strategy to phase I human clinical trials. 2


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: 2024 ( Subtotal = $1,000,000 )
2024	2024	ORLANCE, INC	1124 COLUMBIA ST STE 300	SEATTLE	WA	98104	KING	USA	Allergy and Infectious Diseases Research	001	4	4/30/2024	NON-COMPETING CONTINUATION	$1,000,000
2024	2020	ORLANCE, INC	1124 COLUMBIA ST STE 300	SEATTLE	WA	98104	KING	USA	Allergy and Infectious Diseases Research	000	1	4/4/2024	NEW	$0
														Subtotal = $1,000,000

Issue Date FY: 2023 ( Subtotal = $998,889 )
2023	2023	ORLANCE INC	1124 COLUMBIA ST	SEATTLE	WA	98104	KING	USA	Allergy and Infectious Diseases Research	000	3	5/23/2023	NON-COMPETING CONTINUATION	$998,889
														Subtotal = $998,889

Issue Date FY: 2022 ( Subtotal = $1,000,000 )
2022	2022	ORLANCE, INC.	1124 COLUMBIA ST STE 300	SEATTLE	WA	98104	KING	USA	Allergy and Infectious Diseases Research	001	2	5/3/2022	EXTENSION WITH OR WITHOUT FUNDS	$1,000,000
2022	2020	ORLANCE, INC.	1124 COLUMBIA ST STE 300	SEATTLE	WA	98104	KING	USA	Allergy and Infectious Diseases Research	000	1	4/25/2022	NEW	$0
														Subtotal = $1,000,000

Issue Date FY: 2020 ( Subtotal = $300,000 )
2020	2020	ORLANCE, INC.	4000 15TH AVE NE	SEATTLE	WA	98195	KING	USA	Allergy and Infectious Diseases Research	001	1	8/24/2020	NEW	$0
2020	2020	ORLANCE, INC.	4000 15TH AVE NE	SEATTLE	WA	98195	KING	USA	Allergy and Infectious Diseases Research	000	1	8/7/2020	NEW	$300,000
														Subtotal = $300,000

Grand Total All Awards = $3,298,889

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Universal Influenza A/B Vaccine

Award Number: R44AI153011

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: 08/07/2020

PERIOD OF PERFORMANCE END DATE: 04/30/2026

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