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Novel Targeted Therapies for Pulmonary Fibrosis

Award Number: P01HL119165
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/03/2015
PERIOD OF PERFORMANCE END DATE: 02/28/2022

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Novel Targeted Therapies for Pulmonary Fibrosis - DESCRIPTION (provided by applicant): Novel Targeted Therapies for Pulmonary Fibrosis (P01). Idiopathic pulmonary fibrosis (IPF) is a major, progressive, fatal lung disorder of unknown etiology. It lacks any effective treatment. Promising therapies likely fail because poor lung delivery and tissue penetration have prevented sufficient local drug concentration to achieve efficacy without systemic toxicity. The ability to specifically deliver therapies into the lung tisue has tremendous advantages for patient care. This program project grant is designed to integrate synergistically the activities of 3 projects and 3 core facilities focused on creating and testing novel therapies for IPF. We will use a novel lung delivery platform to reduce toxicity and enhance targeted penetration and therapeutic efficacy of well-known anti-fibrotic biologic agents and small chemotherapeutic inhibitors of key pro-fibrotic signaling pathways mediating IPF. Our extensive vascular proteomic mapping has identified accessible targets on the lung endothelial cell surface that enable rapid and specific lung targeting. More importantly, we also discovered that targeting proteins concentrated in vesicular transporters at the EC surface called caveolae enable antibodies to overcome the normally restrictive EC barrier by pumping them across the vascular wall to reach inside lung tissue within minutes of intravenous injection. From these fundamental discoveries, we are proposing to translate our novel caveolae-targeting strategy into new, enhanced treatments for IPF. Project 1 will test how well this strategy can rapidly deliver and concentrate intravenously injected antibodies and their attached therapeutic cargo (anti-fibrotic protein or chemo-loaded nanogels) specifically in rodent and human lungs. Those antibodies and therapeutic agents that Project 1 determines are pumped effectively will now be used in Projects 2 and 3 to evaluate their targeting and efficacy in fibrotic lungs. Both projects will evaluate human clinical specimens from IPF patients to assess target expression, caveolae function and lung targeting in fibrosis. Core B will generate and characterize all of the retargete therapeutics for each project. Core C will provide to all projects multiple imaging capabilities to comprehensively track the lung targeting and tissue processing of each retargeted therapeutic agent after intravenous injection. The Administrative and Biostatistical Core A will make both administrative and statistical capabilities available to all projects to potentiate data management and the pace and quality of the P01 research. This P01 program may initiate a paradigm shift in how pulmonary therapies are delivered, offering hope for patients with IPF and other devastating lung diseases.


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: 2023 ( Subtotal = $0 )
2023	2019	PROTEOGENOMICS RESEARCH INSTITUTE FOR SYSTEMS MEDICINE	505 COAST BLVD S	LA JOLLA	CA	92037	SAN DIEGO	USA	Lung Diseases Research	000	5	5/15/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = -$35 )
2022	2019	PROTEOGENOMICS RESEARCH INSTITUTE	505 COAST BLVD S	LA JOLLA	CA	92037	SAN DIEGO	USA	Lung Diseases Research	000	5	7/11/2022	NON-COMPETING CONTINUATION	-$35
														Subtotal = -$35

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2019	PROTEOGENOMICS RESEARCH INSTITUTE FOR SYSTEMS MEDICINE	505 COAST BLVD S STE 209	LA JOLLA	CA	92037	SAN DIEGO	USA	Lung Diseases Research	000	5	2/16/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $2,697,594 )
2019	2019	PROTEOGENOMICS RESEARCH INSTITUTE FOR SYSTEMS MEDICINE	505 COAST BLVD S STE 209	LA JOLLA	CA	92037	SAN DIEGO	USA	Lung Diseases Research	000	5	4/29/2019	NON-COMPETING CONTINUATION	$2,697,594
														Subtotal = $2,697,594

Issue Date FY: 2018 ( Subtotal = $2,697,831 )
2018	2018	PROTEOGENOMICS RESEARCH INSTITUTE FOR SYSTEMS MEDICINE	505 COAST BLVD S STE 209	LA JOLLA	CA	92037	SAN DIEGO	USA	Lung Diseases Research	001	4	7/14/2018	NON-COMPETING CONTINUATION	$53,958
2018	2018	PROTEOGENOMICS RESEARCH INSTITUTE FOR SYSTEMS MEDICINE	505 COAST BLVD S STE 209	LA JOLLA	CA	92037	SAN DIEGO	USA	Lung Diseases Research	000	4	2/23/2018	NON-COMPETING CONTINUATION	$2,643,873
														Subtotal = $2,697,831

Issue Date FY: 2017 ( Subtotal = $2,698,059 )
2017	2017	PROTEOGENOMICS RESEARCH INSTITUTE FOR SYSTEMS MEDICINE	11211 SORRENTO VALLEY RD STE X	SAN DIEGO	CA	92121	SAN DIEGO	USA	Lung Diseases Research	000	3	2/27/2017	NON-COMPETING CONTINUATION	$2,698,059
														Subtotal = $2,698,059

Issue Date FY: 2016 ( Subtotal = $2,698,274 )
2016	2016	PROTEOGENOMICS RESEARCH INSTITUTE FOR SYSTEMS MEDICINE	11211 SORRENTO VALLEY ROAD	SAN DIEGO	CA	92121	SAN DIEGO	USA	Lung Diseases Research	000	2	3/2/2016	NON-COMPETING CONTINUATION	$2,698,274
														Subtotal = $2,698,274

Issue Date FY: 2015 ( Subtotal = $2,783,129 )
2015	2015	PROTEOGENOMICS RESEARCH INSTITUTE FOR SYSTEMS MEDICINE	11211 SORRENTO VALLEY ROAD	SAN DIEGO	CA	92121	SAN DIEGO	USA	Lung Diseases Research	001	1	5/20/2015	NEW	$883,350
2015	2015	PROTEOGENOMICS RESEARCH INSTITUTE FOR SYSTEMS MEDICINE	11211 SORRENTO VALLEY ROAD	SAN DIEGO	CA	92121	SAN DIEGO	USA	Lung Diseases Research	000	1	3/3/2015	NEW	$1,899,779
														Subtotal = $2,783,129

Grand Total All Awards = $13,574,852

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Novel Targeted Therapies for Pulmonary Fibrosis

Award Number: P01HL119165

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 03/03/2015

PERIOD OF PERFORMANCE END DATE: 02/28/2022

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