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Improving availability of ImmunoPET via automation of radio-synthesis and quality control of antibody-based cancer imaging PET tracers on a single platform.

Award Number: R43CA235909
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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ImmunoPET (Positron Emission Tomography) has been specifically identified in Blue Ribbon Panel report (pg 53) as a transformative research recommendation for achieving Cancer Moonshot’s ambitious goal of making a decade’s worth of progress in 5 years. The broad long-term objective of this application is to expand availability of ImmunoPET from select few top-tier research centers to the broad cancer patient population across the US. The main issue preventing such expansion today is rooted in production complexity of ImmunoPET tracers, radioactively labeled antibodies used as contrast agents. These activities are directly related to the mission of the NCI. Trace-Ability proposes to automate the entire production procedure including radio-labeling, QC and immunoassay with results available before the PET scan. Production staff will need only to add the radionuclide, initiate the process and return to collect the product along with QC report. Such solution will enable more facilities to produce ImmunoPET tracers, each facility to support more patients and fewer patients having to repeat scans due to low immunoreactivity of the tracer. Tracer-QC is a radically-innovative automated solution for QC of PET tracers based on integration of plate reader, liquid handler and HPLC machine. A kit of reagents and consumables enables hands-free operation. Tracer-QC platform will be used to automate the complete production process including synthesis, QC and pre-release immunoreactivity. The level of automation in the resulting system was previously inconceivable because traditional synthesis and QC processes rely on highly specialized procedures and cannot share system components. New capabilities that need to be enabled on Tracer-QC for ImmunoPET applications are radiolabeling and immunoreactivity assay. PET tracer chosen for this project is [89Zr]DFO-Pembrolizumab, targeting PD-1 receptors expressed on the surface of activated T-cells, proposed based on the breadth of its applications in cancer imaging. Specific Aim 1: Demonstrate feasibility of automated [89Zr]DFO-Pembrolizumab synthesis on Tracer-QC platform. Radiolabeling, which falls outside of QC procedure scope has never been enabled on Tracer-QC, although it appears conceptually feasible. Quantitative milestones: (a) Automated synthesis of [89Zr]DFO-Pembrolizumab starting with [89Zr]-oxalate finished using only Tracer-QC and no manual operations. (b) 70% Radiochemical yield. Specific Aim 2: Demonstrate complete [89Zr]DFO- Pembrolizumab QC performed on Tracer-QC. QC of antibody-based tracers includes tests similar to FDG plus a binding assay that takes 24-48h. Quantitative milestones: (a) Binding affinity measured by Tracer- QC and traditional method agree within 20%. (b) Binding assay completed in < 3 hours. (c) Demonstration of all other [89Zr]DFO-Pembrolizumab QC measurements on Tracer-QC.


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 = $0 )
2021	2019	TRACE-ABILITY, INC.	6919B WOODLEY AVE	VAN NUYS	CA	91406	LOS ANGELES	USA	Cancer Detection and Diagnosis Research	000	1	3/15/2021	NEW	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $299,987 )
2019	2019	TRACE-ABILITY, INC.	6919B WOODLEY AVE	VAN NUYS	CA	91406	LOS ANGELES	USA	Cancer Detection and Diagnosis Research	000	1	9/18/2019	NEW	$299,987
														Subtotal = $299,987

Grand Total All Awards = $299,987

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Improving availability of ImmunoPET via automation of radio-synthesis and quality control of antibody-based cancer imaging PET tracers on a single platform.

Award Number: R43CA235909

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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