Development of a phenotype-based predictive analytic for acute myeloid leukemia
Active Project Grant Awarded Last action
- Award ID
- R01CA262287
- Recipient
-
Vanderbilt University Medical Center UEI GYLUH9UXHDX5
- Awarding agency
-
National Cancer Institute
National Institutes of Health, Department of Health and Human Services
- Obligated
- $7,576,108
Award facts
- Assistance listing
- 93.395 Cancer Treatment Research
- Completion date 93% complete
- Originally
- Funding
-
- $6,979,101.00 Federal
- $597,007.00 Non-federal
- Place of performance
- Nashville, TN 37232, USA
Award details come from USAspending.gov.
Description
- Abstract
- The 5-year overall survival from acute myeloid leukemia (AML) is less than 30%. While some patients are cured with initial induction therapy, most patients relapse, and the expected outcomes in patients with relapsed and refractory (r/r) AML are dismal. For this reason, developing methods to identify therapies likely to benefit r/r AML patients is a top priority. This proposal aims to address critical unmet needs with a unique academic- industry partnership (AIP) between investigators at vanderbilt university medical center, karyopharm therapeutics, and notable labs. The BCL2 inhibitor, venetoclax (VEN), is transforming clinical practice for AML, but activity in r/r AML is less pronounced, and resistance occurs in most patients. AIP investigators currenty lead a multi-site investigator-sponsored study, testing VEN in combination with the selective inhibitor of nuclear export (sine) selinexor (SEL) in a phase i trial for r/r AML (NCT03955783). This SEL/VEN trial grew from the discovery that SEL synergizes with VEN and overcomes resistance mechanisms in some VEN-insensitive patient samples. Given this, our AIP team has worked together to develop a precision medicine functional platform for this novel combination in r/r AML. Notable labs utilizes an automated high-throughput, immunophenotype-based flow cytometry method to provide real time drug sensitivity data on multiple, specific cell populations simultaneously within a given patient sample. Building from the only annotated cohort of patient samples treated with SEL/VEN in the world, we propose to develop a precision medicine functional assay to identify r/r AML patients most likely to benefit from sine/VEN combination therapy. We will build, refine and optimize the functional platform for SEL/VEN with samples from our current phase i study and train the platform on samples from the phase 2 SEL/VEN clinical trial proposed by the AIP. Aim 1 will focus on determining assay parameters specifically for SEL/VEN in r/r AML. Aim 2 will train the model with the phase II clinical trial of SEL/VEN in r/r AML, and aim 3 will contextualize the predictive analytic model on heterogenous genotypes found in r/r AML. At the conclusion of this study, the functional medicine platform will be a companion diagnostic ready for external validation which we will lead in a phase III efficacy trial of SEL/VEN in r/ r AML, and serve as proof-of-principle for development of similar therapy-specifc precision medicine tools.
Transactions
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| Amendment | $597,007 | $0 | |
| Original award | $597,007 | $597,007 |
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Subawards
| Subrecipient | Amount | Awarded |
|---|---|---|
| Karyopharm Therapeutics Inc. | $5,586 | |
| Baptist Memorial Hospital-Tipton | $169,862 | |
| Karyopharm Therapeutics Inc. | $5,492 | |
| Notable Labs, Inc. | $70,566 | |
| Notable Labs, Inc. | $111,427 |
Quick answers
Who received award R01CA262287?
R01CA262287 was awarded to Vanderbilt University Medical Center by National Cancer Institute (National Institutes of Health) on September 15, 2021.
How much is award R01CA262287 worth?
$7,576,108 has been obligated on R01CA262287: $6,979,101 in federal funding and $597,007 in non-federal funding.
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