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Sonoporation as a novel delivery platform for an HIV DNA vaccine

Award Number: R03AI141031
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: 01/14/2019
PERIOD OF PERFORMANCE END DATE: 12/31/2020

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Sonoporation as a novel delivery platform for an HIV DNA vaccine - Abstract Profectus Biosciences leverages its platform technologies of adjuvanted DNA vaccines to stimulate robust Th1- biased immune responses likely necessary for protection against challenging viral diseases such as HIV. We believe that optimized delivery methods are critical for development of effective genetic vaccines that can elicit these types of responses. Like others, we often deliver our DNA-based vaccines using electroporation. However, the logistical difficulties and pain associated with delivering vaccines via EP leads to doubt that it will ever be a realistic delivery modality for mass vaccination with prophylactic vaccines. For this reason, there is strong interest in development of alternative DNA delivery techniques. Ultrasound is a safe, non-invasive, effective method with which microbubbles can be used to propel attached or associated payloads into permeabilized target tissues. High acoustic ultrasound (well within FDA guidelines) of plasmid DNA with microbubbles induces unstable oscillation and ultimate collapse of the latter, leading to minor cell membrane disruption that allows the plasmid to enter nearby cells. Previous studies in animals have found ultrasound with microbubbles and plasmid DNA to promote protein production in targeted organs. Under this application, we will develop ultrasound-mediated gene transfer, or sonoporation, using microbubbles, as a painless replacement for electroporation. The ultrasound delivery platform will be developed using our well-established plasmid DNA vaccine, which encodes the HIV vaccine immunogen, Full-Length Single Chain (FLSC), and our IL-12 DNA adjuvant, as our “model” vaccine. Although we will initially develop this sonoporation delivery technology for our HIV DNA vaccine, we believe that this same delivery technology will be suitable for virtually any DNA- or mRNA-based vaccine. Therefore, the development of this delivery technology should not only benefit the HIV vaccine field but the field of vaccinology in general. 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: 2022 ( Subtotal = -$123,999 )
2022	2020	PROFECTUS BIOSCIENCES, INC.	6411 BECKLEY ST STE 201	BALTIMORE	MD	21224	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	004	2	2/22/2022	NON-COMPETING CONTINUATION	$0
2022	2020	PROFECTUS BIOSCIENCES, INC.	401 N MIDDLETOWN RD # 205	PEARL RIVER	NY	10965	ROCKLAND	USA	Allergy and Infectious Diseases Research	001	2	11/4/2021	NON-COMPETING CONTINUATION	-$69,471
2022	2020	PROFECTUS BIOSCIENCES, INC.	401 N MIDDLETOWN RD # 205	PEARL RIVER	NY	10965	ROCKLAND	USA	Allergy and Infectious Diseases Research	003	2	2/15/2022	NON-COMPETING CONTINUATION	-$54,528
2022	2019	PROFECTUS BIOSCIENCES, INC.	401 N MIDDLETOWN RD # 205	PEARL RIVER	NY	10965	ROCKLAND	USA	Allergy and Infectious Diseases Research	002	1	1/31/2022	NEW	$69,538
2022	2019	PROFECTUS BIOSCIENCES, INC.	401 N MIDDLETOWN RD # 205	PEARL RIVER	NY	10965	ROCKLAND	USA	Allergy and Infectious Diseases Research	000	1	11/4/2021	NEW	-$69,538
														Subtotal = -$123,999

Issue Date FY: 2020 ( Subtotal = $69,471 )
2020	2020	PROFECTUS BIOSCIENCES, INC.	6411 BECKLEY ST STE 201	BALTIMORE	MD	21224	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	000	2	1/2/2020	NON-COMPETING CONTINUATION	$69,471
														Subtotal = $69,471

Issue Date FY: 2019 ( Subtotal = $69,538 )
2019	2019	PROFECTUS BIOSCIENCES, INC.	6411 BECKLEY ST STE 201	BALTIMORE	MD	21224	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	000	1	1/7/2019	NEW	$69,538
2019	2019	PROFECTUS BIOSCIENCES, INC.	6411 BECKLEY ST STE 201	BALTIMORE	MD	21224	BALTIMORE CITY	USA	Allergy and Infectious Diseases Research	001	1	8/6/2019	NEW	$0
														Subtotal = $69,538

Grand Total All Awards = $15,010

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Sonoporation as a novel delivery platform for an HIV DNA vaccine

Award Number: R03AI141031

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: 01/14/2019

PERIOD OF PERFORMANCE END DATE: 12/31/2020

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