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Development of a novel disease-modifying glycan therapeutic for early at-home intervention of acute vaso-occlusive crisis in sickle cell disease

Award Number: R44HL167473
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/05/2023
PERIOD OF PERFORMANCE END DATE: 02/28/2026

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Development of a novel disease-modifying glycan therapeutic for early at-home intervention of acute vaso-occlusive crisis in sickle cell disease - PROJECT SUMMARY/ABSTRACT Current therapies for sickle cell disease largely fail to meet patient needs, particularly for the management of acute pain crisis associated with this devastating disease. Healthcare systems are largely ill-equipped for managing patients in the midst of these extremely painful and life-threatening events, leaving patients with medical distrust and no effective treatment option. We are therefore developing IHP-100 for at-home self- management of pain crisis, thus empowering patients and providing significant freedom from disease. IHP-100 is a novel P-selectin and complement inhibitor that is administered by subcutaneous injection at the onset of early symptoms of pain crisis. This is a major paradigm shift in care that builds on our recent understanding of sickle cell pathology and incorporates direct patient feedback to provide a truly effective treatment. IHP-100 is a novel glycan-based therapeutic, designed to target the key underlying pathology of vaso-occlusive crisis (VOC). VOC is multi-factorial and includes both cellular adhesion via selectins as well as complement activation. Glycans are a prime drug class for such complex pathologies given their pleiotropic activities. We have therefore engineered IHP-100 as a single agent that potently inhibits P-selectin as well as complement. IHP-100 is therefore highly differentiated both in its biological activity and in its treatment paradigm at the earliest symptom of pain crisis. We have shown that IHP-100 inhibits P-selectin mediated cell binding to inflamed endothelium, inhibits complement-mediated cell lysis, and reduces vaso-occlusions in the Townes sickle cell disease mouse model of VOC. In the proposed work, we will optimize the dose level for in vivo efficacy, transfer manufacturing and analytical testing to a GMP facility, and complete non-clinical IND enabling dose-range finding studies. We will also further investigate mechanisms of IHP-100 in a P-selectin-deficient Townes sickle cell mouse model, and establish an adhesion-based biomarker strategy for clinical development.


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: 2026 ( Subtotal = $0 )
2026	2024	IHP THERAPEUTICS INC	930 BRITTAN AVE	SAN CARLOS	CA	94070	SAN MATEO	USA	Blood Diseases and Resources Research	000	3	6/16/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $1,192,753 )
2024	2024	IHP THERAPEUTICS INC	930 BRITTAN AVE	SAN CARLOS	CA	94070	SAN MATEO	USA	Blood Diseases and Resources Research	003	3	6/14/2024	NON-COMPETING CONTINUATION	$1,192,753
2024	2023	IHP THERAPEUTICS INC	930 BRITTAN AVE	SAN CARLOS	CA	94070	SAN MATEO	USA	Blood Diseases and Resources Research	001	2	2/12/2024	EXTENSION WITH OR WITHOUT FUNDS	$114,061
2024	2023	IHP THERAPEUTICS INC	930 BRITTAN AVE	SAN CARLOS	CA	94070	SAN MATEO	USA	Blood Diseases and Resources Research	002	2	5/23/2024	EXTENSION WITH OR WITHOUT FUNDS	$0
2024	2023	IHP THERAPEUTICS INC	930 BRITTAN AVE	SAN CARLOS	CA	94070	SAN MATEO	USA	Blood Diseases and Resources Research	000	1	2/12/2024	NEW	-$114,061
														Subtotal = $1,192,753

Issue Date FY: 2023 ( Subtotal = $1,419,113 )
2023	2023	IHP THERAPEUTICS, INC.	930 BRITTAN AVE	SAN CARLOS	CA	94070	SAN MATEO	USA	Blood Diseases and Resources Research	000	1	3/5/2023	NEW	$301,480
2023	2023	IHP THERAPEUTICS INC	930 BRITTAN AVE	SAN CARLOS	CA	94070	SAN MATEO	USA	Blood Diseases and Resources Research	003	2	8/18/2023	EXTENSION WITH OR WITHOUT FUNDS	$1,117,633
2023	2023	IHP THERAPEUTICS, INC.	930 BRITTAN AVE	SAN CARLOS	CA	94070	SAN MATEO	USA	Blood Diseases and Resources Research	001	1	3/10/2023	NEW	$0
2023	2023	IHP THERAPEUTICS INC	930 BRITTAN AVE	SAN CARLOS	CA	94070	SAN MATEO	USA	Blood Diseases and Resources Research	002	1	6/21/2023	NEW	$0
														Subtotal = $1,419,113

Grand Total All Awards = $2,611,866

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Development of a novel disease-modifying glycan therapeutic for early at-home intervention of acute vaso-occlusive crisis in sickle cell disease

Award Number: R44HL167473

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 03/05/2023

PERIOD OF PERFORMANCE END DATE: 02/28/2026

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