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ExpLoiting thErapeutic VulnerAbilities in hepaTocEllular carcinoma (ELEVATE)

Award Number: P01CA275740
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/08/2024
PERIOD OF PERFORMANCE END DATE: 07/31/2029

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ExpLoiting thErapeutic VulnerAbilities in hepaTocEllular carcinoma (ELEVATE) - OVERALL: SUMMARY Hepatocellular carcinoma (HCC), the primary malignancy of hepatocytes, is a diagnosis with bleak outcomes. With the alarming rise in global obesity incidence, obesity-induced non-alcoholic steatohepatitis (NASH) is becoming a leading cause of HCC. HCC is usually diagnosed at an advanced stage when the tumor is unresectable. The most effective FDA-approved treatment for advanced non-resectable HCC is a combination of anti-PD-L1 (atezolizumab) and anti-VEGF (bevacizumab) antibodies, providing an overall response rate of 27%. Apart from immunotherapy, systemic therapy with tyrosine kinase inhibitors (TKIs, such as sorafenib or lenvatinib) provides only a modest (~3 months) increase in overall survival and causes drug resistance within six months. Recent studies document that immunotherapy may be less effective in patients with NASH-HCC than in HCC patients with viral hepatitis. Thus, there is an unmet need to develop novel and effective modalities of treatment for advanced HCC. This P01 proposal ExpLoiting theErapeutic VulnerAbilities in hepaTocEllular carcinoma (ELEVATE), which involves four projects, an administrative core (Core 1), a mouse model and pathological analysis core (Core 2), and a biostatistics and bioinformatics core (Core 3; BBC), aims to interrogate molecular changes in HCC and exploit them to develop combinatorial treatment approaches especially targeted to NASH-HCC. The overall objectives include interrogation of molecular mechanisms regulating NASH-HCC and the development of novel combinatorial treatment approaches based on the identified molecular abnormalities, evaluation of approaches that improve efficacy of approved immunotherapy using an authentic NASH-HCC mouse model, and development and evaluation of novel approaches that engage the immune system to counteract HCC (inflammatory and NASH-HCC). To achieve this objective, this P01 comprises experts, with an established history of highly integrated interaction, in HCC biology and mouse modeling, liver physiology and pathology, medicinal chemistry, cancer immunotherapy, pathological diagnosis, nanoparticle delivery, and bioinformatics and biostatistics. Successful completion of the proposed studies will significantly advance our understanding of the molecular mechanism of HCC pathogenesis and novel therapeutics and generate translationally relevant data from pre-clinical models having the potential to radically transform the management of HCC patients facilitating prolonged survival. Thus, this innovative P01 grant has high mechanistic and translational significance. ELEVATE brings together the expertise of a highly integrated team providing synergistic outcomes that may not be delivered by each project alone.


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 = $2,646,688 )
2025	2025	VIRGINIA COMMONWEALTH UNIVERSITY	910 WEST FRANKLIN ST	RICHMOND	VA	23284	RICHMOND CITY	USA	Cancer Treatment Research	000	2	8/5/2025	NON-COMPETING CONTINUATION	$2,646,688
														Subtotal = $2,646,688

Issue Date FY: 2024 ( Subtotal = $2,678,459 )
2024	2024	VIRGINIA COMMONWEALTH UNIVERSITY	910 WEST FRANKLIN ST	RICHMOND	VA	23284	RICHMOND CITY	USA	Cancer Treatment Research	000	1	8/1/2024	NEW	$2,678,459
														Subtotal = $2,678,459

Grand Total All Awards = $5,325,147

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ExpLoiting thErapeutic VulnerAbilities in hepaTocEllular carcinoma (ELEVATE)

Award Number: P01CA275740

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/08/2024

PERIOD OF PERFORMANCE END DATE: 07/31/2029

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