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Optimization of LGM2605 for use as a device in lung transplant

Award Number: R44HL140680
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2018
PERIOD OF PERFORMANCE END DATE: 08/31/2024

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Optimization of LGM2605 for use as a device in lung transplant - LignaMed, LLC is developing a novel small molecule device, LGM2605, that will be utilized and administered via FDA approved ex vivo lung perfusion (EVLP), to improve lung function parameters of ex vivo donor lungs in advance of transplant surgery. Per FDA device regulations LGM2605 will be fully cleared from the donor lung prior to transplant. This work supports the efforts of the NHLBI to promote the prevention and treatment of lung diseases and enhance the health of individuals to live longer and more fulfilling lives, and also addresses an NHLBI stated goal of expanding the donor lung pool. Chronic lung diseases affect 35 million Americans and result in almost 400,000 deaths annually. Lung transplantation is the only life-saving therapy for patients with certain types of end-stage lung disease. However, the procedure has limited availability because not all donor lungs are safe for transplantation. This shortage of donor lungs results in the death of 20 percent of lung transplant candidates awaiting transplant. This shortage arises in part from damage to donor lungs prior to and during preservation due to generation of reactive oxygen species (ROS) and subsequent oxidative lung tissue damage. This damage is also linked to eventual primary graft dysfunction (PGD) after transplantation. PGD arises from ischemia/reperfusion (I/R) Injury associated with storage and transplant maneuvers. Allograft quality combined with ROS and other oxidants produced with I/R lead to direct damage that decreases the pool of transplantable lungs. Thus, blocking ROS is a critical step in reducing ROS-induced damage. LignaMed's novel device works through a unique three-prong mode of action to impact reactive ROS via a) direct free radical scavenging, b) activation of the Nrf2/antioxidant response element (ARE) pathway and c) decrease of ROS production via inhibition of inflammasome and inflammatory cell influx (neutrophils / macrophages) . LGM2605 has excellent drug-like properties including desirable physiochemical properties and oral bioavailable. PK/PD studies in mouse and non-human primates have shown good oral, intravenous and subcutaneous distribution while studies in the EVLP model show excellent exposure to lung tissue with aerosolized drug. When administered to mice, LGM2605 prevented radiation-induced lung inflammation and fibrosis and improved lung function parameters and arterial blood oxygenation. Moreover when administered via EVLP in pilot studies run in collaboration with Dr. Christie's group at the University of Pennsylvania, LGM2605 significantly improved/rehabilitated lung function parameters in donor lungs that previously failed to meet “transplant viable” acceptance criteria. In this Fast-track SBIR proposal, our Phase I aims will focus to characterize the kinetics of inhaled LGM2605. In Phase II we will validate the magnitude of the effect and determine safety in an expanded patient population. LignaMed has submitted a background and meeting request package to FDA.


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 = -$191,989 )
2025	2021	LIGNAMED, LLC	490 BELFRY DR	BLUE BELL	PA	19422	MONTGOMERY	USA	Lung Diseases Research	000	3	12/29/2024	NON-COMPETING CONTINUATION	-$191,989
														Subtotal = -$191,989

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2021	LIGNAMED, LLC	490 BELFRY DR	BLUE BELL	PA	19422	MONTGOMERY	USA	Lung Diseases Research	001	3	4/19/2024	NON-COMPETING CONTINUATION	$0
2024	2021	LIGNAMED, LLC	3675 MARKET ST STE 200	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Lung Diseases Research	000	3	10/20/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2021	LIGNAMED, LLC	3675 MARKET ST STE 200	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Lung Diseases Research	000	3	3/10/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $916,148 )
2021	2021	LIGNAMED, LLC	3675 MARKET ST STE 200	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Lung Diseases Research	001	3	7/13/2021	NON-COMPETING CONTINUATION	$0
2021	2021	LIGNAMED, LLC	3675 MARKET ST STE 200	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Lung Diseases Research	000	3	2/15/2021	NON-COMPETING CONTINUATION	$916,148
														Subtotal = $916,148

Issue Date FY: 2020 ( Subtotal = $1,440,044 )
2020	2020	LIGNAMED, LLC	3711 MARKET ST STE 866	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Lung Diseases Research	001	2	2/10/2020	EXTENSION WITH OR WITHOUT FUNDS	$1,440,044
2020	2018	LIGNAMED, LLC	3711 MARKET ST STE 866	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Lung Diseases Research	000	1	2/6/2020	NEW	$0
2020	2018	LIGNAMED, LLC	3711 MARKET ST STE 866	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Lung Diseases Research	002	1	9/16/2020	NEW	$0
														Subtotal = $1,440,044

Issue Date FY: 2018 ( Subtotal = $299,687 )
2018	2018	LIGNAMED, LLC	3711 MARKET ST STE 866	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	Lung Diseases Research	000	1	8/15/2018	NEW	$299,687
														Subtotal = $299,687

Grand Total All Awards = $2,463,890

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Optimization of LGM2605 for use as a device in lung transplant

Award Number: R44HL140680

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/01/2018

PERIOD OF PERFORMANCE END DATE: 08/31/2024

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