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A randomized, placebo-controlled, single-blinded clinical trial to assess safety and efficacy of CD24Fc in controlling cardiovascular disease risks of HIV-infected patients

Award Number: R44HL145964
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2019
PERIOD OF PERFORMANCE END DATE: 02/28/2021

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A randomized, placebo-controlled, single-blinded clinical trial to assess safety and efficacy of CD24Fc in controlling cardiovascular disease risks of HIV-infected patients - Project Summary/Abstract Infection with Human Immunodeficiency Virus (HIV) affects an estimated 36.7 million worldwide. In the United States, an estimated 1.1 million people are infected. As the access to antiretroviral treatment (ART) has increased, the population of people infected with HIV live longer. Patients with viral suppression have increased life expectancy. However, compare to age-matched individual without HIV infection, they have shortened lifespan with higher rates of comorbidities, including cardiovascular diseases (CVD). Persistent inflammation and chronic immune activation caused by HIV and likely ART results in a pro-inflammatory state that increases the risk for cardiovascular disease. Though statins have been used to decrease the effects of hyperlipidemia and inflammation on progression of cardiovascular disease, use of statins is underutilized in patients with HIV and falls short of realistic goals for LDL reduction in these high-risk patients. Human CD24Fc, developed by OncoImmune, Inc., is a recombinant fusion protein composed of the extracellular domain of human CD24 and the Fc fragment of human IgG1. CD24 is expressed in wide range of cell types as an important genetic modifier for several autoimmune diseases and inflammation in response to danger- associated molecular pattern (DAMPs). Our published data demonstrated that CD24Fc prevented SIV-infected macaques from developing AIDS through induction of inhibitors of inflammation while suppressing promotors for inflammation and autoimmune disease. Our unpublished data showed that in human CD34+ hematopoietic stem cell-reconstituted mouse HIV model, CD24Fc treatment suppressed production of inflammatory cytokines and reduced activation and loss of CD4 T cells. In a Phase I clinical trial in healthy people, ascending doses of CD24Fc (up to 240 mg) significantly decreased fasting LDL level and induced leptin level in serum. The reduction of fasting LDL by CD24Fc is confirmed in a Phase IIa clinical trial in patients undergo hematopoietic stem cell transplantation for leukemia. The results are consistent with the recently discovered connection between inflammation and metabolic disorders. Based on these preliminary results, we propose that treatment with CD24Fc can fortify negative regulation of innate immune responses, decrease LDL, and thus reduce the risk of cardiovascular disease in HIV patients. To test this hypothesis, we will evaluate, in HIV-infected individuals, the safety and efficacy of CD24Fc in normalizing lipid metabolism, reducing T cell activation and viral reservoir. Sixty-four patients aged over 50 with HIV infection who are virally suppressed on antiretroviral therapy for over 2 years will be randomized in a 1:1 ratio to receive either 240mg of CD24Fc or placebo for 12 weeks, with a 24-week follow-up period. We will evaluate the safety and tolerability of the drug as well as the changes in LDL and other cellular and soluble inflammatory parameters with CD24Fc treatment and perform nuclear imaging studies to evaluate changes in myocardial perfusion and function with CD24Fc treatment. This clinical trial will enroll an HIV cohort with 78% of African American. The study will uncover critical knowledge in our understanding of the pathogenesis of adverse cardiovascular outcomes in HIV- infected patients and test a novel approach for treating refractory hyperlipidemia.


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: 2021 ( Subtotal = -$1,212 )
2021	2019	ONCOIMMUNE INC	9430 KEY WEST AVE STE 113	ROCKVILLE	MD	20850	MONTGOMERY	USA	Cardiovascular Diseases Research	000	1	6/30/2021	NEW	-$1,212
														Subtotal = -$1,212

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2019	ONCOIMMUNE INC	9430 KEY WEST AVE STE 113	ROCKVILLE	MD	20850	MONTGOMERY	USA	Cardiovascular Diseases Research	001	1	2/21/2020	NEW	$0
2020	2019	ONCOIMMUNE INC	9430 KEY WEST AVE STE 113	ROCKVILLE	MD	20850	MONTGOMERY	USA	Cardiovascular Diseases Research	000	1	11/20/2019	NEW	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $212,653 )
2019	2019	ONCOIMMUNE INC	9430 KEY WEST AVE STE 113	ROCKVILLE	MD	20850	MONTGOMERY	USA	Cardiovascular Diseases Research	000	1	8/29/2019	NEW	$212,653
														Subtotal = $212,653

Grand Total All Awards = $211,441

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A randomized, placebo-controlled, single-blinded clinical trial to assess safety and efficacy of CD24Fc in controlling cardiovascular disease risks of HIV-infected patients

Award Number: R44HL145964

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/01/2019

PERIOD OF PERFORMANCE END DATE: 02/28/2021

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