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AML MutationCounter a tool to detect residual and recurrent leukemia

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41CA213690-01
Agency Tracking Number: R41CA213690
Amount: $220,087.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 102
Solicitation Number: PA15-270
Solicitation Year: 2015
Award Year: 2017
Award Start Date (Proposal Award Date): 2017-08-01
Award End Date (Contract End Date): 2019-07-31
Small Business Information
Durham, NC 27707-5700
United States
DUNS: 080330446
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (919) 913-4551
Business Contact
Phone: (919) 966-8209
Research Institution
CHAPEL HILL, NC 27599-0001
United States

 Nonprofit college or university

AsystBio LLC proposes to market a molecular tool kit called AML MutationCounter to count somatic mutations
in genes that contribute to the development of acute myeloid leukemia AML We have developed a set of
reagents and computer programs for application of next generation sequencing to count AML gene mutations
The tool kit is versatile and can be used with either of the two major DNA sequencing platforms Illumina Hi
Seq and ThermoFisher Ion Proton Every year AML afflicts Americans with nearly dying from
the disease Many patients respond to primary therapy and achieve clinical remission Remission is currently
determined by a reduction of leukemic blasts in bone marrow to andlt of cells A more sensitive and specific
test for remission may guide clinicians to achieve more durable remission and improve stratification of patients
for likelihood of relapse One recent study found that forty eight percent of patients in remission retained AML
gene mutations in andgt of marrow or blood cells and these patients survival was on average of that
seen in patients who cleared mutations to andlt during remission Thus the presence or absence of residual
disease at remission is highly prognostic Patients who receive a bone marrow transplant after remission
sometimes display emerging clones of host bone marrow termed bone marrow chimerism It is important to
determine whether these emerging clones represent recurrent leukemia as early as possible to implement
salvage therapies Our advisory panel of oncologists at the University of North Carolina and NC Memorial
Hospital expresses enthusiasm for a sensitive accurate rapid and low cost test for residual and recurrent
leukemia Studies in this Phase I STTR grant application will involve a collaboration between AsystBio LLC and
the University of North Carolina at Chapel Hill to produce a molecular tool kit for measurement of AML
associated somatic gene mutations in bone marrow specimens Studies in Aim will establish the accuracy
sensitivity and reproducibility of the kit for quantification of mutant allele frequencies using simulated data and
a standard reference cell line Studies in Aim will apply the tool kit to patient samples that were collected
at the time of remission before a subsequent recurrence of leukemia Samples are selected to include the
NPM leukemia driver gene mutation in the primary cancer The presence of mutations in NPM in remission
samples is a poor prognostic sign We will show that our kit detects mutations in NPM and other AML
associated genes at remission in patients that were destined to relapse This phase I project demonstrates the
feasibility of AML MutationCounter for detection of minimal residual and recurrent disease in AML Our phase II
commercialization plan will include a clinical trial to establish the utility of the test kit as well as active marketing
of the test kit to academic medical centers and commercial test laboratories Project Narrative
AsystBio LLC will produce a molecular tool kit that combines existing next generation DNA sequencing
technology with AsystBio s proprietary computer programs for sensitive detection of AML associated gene
mutations The ability to detect residual or recurrent tumor cells results in better guidance in the clinic for
when to continue or cease induction therapy when to transplant and when mutations are actionable for use of
targeted therapies

* Information listed above is at the time of submission. *

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