SBIR-STTR Award

  1. You are here:    Home
  2. Search Databases
  3. Search SBIR-STTR Awards
  4. SBIR-STTR Award

Improving availability of ImmunoPET via automation of radio-synthesis and quality control of antibody-based HIV imaging PET tracers on a single platform.
Award last edited on: 1/31/2024

Sponsored Program
SBIR
Awarding Agency
NIH : NIAID
Total Award Amount
$1,299,987
Award Phase
2
Solicitation Topic Code
394
Principal Investigator
Arkadij Elizarov

Company Information

Trace-Ability Inc

2446 20th Street
Santa Monica, CA 90405
   (310) 988-0463
   N/A
   www.traceabilityinc.com
Location: Single
Congr. District: 33
County: Los Angeles

Phase I

Contract Number: 1R43CA235909-01A1
Start Date: 9/18/2019    Completed: 8/31/2020
Phase I year
2019
Phase I Amount
$299,987
ImmunoPET (Positron Emission Tomography) has been specifically identified in Blue Ribbon Panelreport (pg 53) as a transformative research recommendation for achieving Cancer Moonshot's ambitiousgoal of making a decade's worth of progress in 5 years. The broad long-term objective of this applicationis to expand availability of ImmunoPET from select few top-tier research centers to the broad cancer patientpopulation across the US. The main issue preventing such expansion today is rooted in productioncomplexity of ImmunoPET tracers, radioactively labeled antibodies used as contrast agents. Theseactivities are directly related to the mission of the NCI. Trace-Ability proposes to automate the entire production procedure including radio-labeling, QC andimmunoassay with results available before the PET scan. Production staff will need only to add theradionuclide, initiate the process and return to collect the product along with QC report. Such solution willenable more facilities to produce ImmunoPET tracers, each facility to support more patients and fewerpatients 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 ofplate reader, liquid handler and HPLC machine. A kit of reagents and consumables enables hands-freeoperation. Tracer-QC platform will be used to automate the complete production process includingsynthesis, QC and pre-release immunoreactivity. The level of automation in the resulting system waspreviously inconceivable because traditional synthesis and QC processes rely on highly specializedprocedures and cannot share system components. New capabilities that need to be enabled on Tracer-QCfor ImmunoPET applications are radiolabeling and immunoreactivity assay. PET tracer chosen for this project is [89Zr]DFO-Pembrolizumab, targeting PD-1 receptors expressedon 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 onTracer-QC platform. Radiolabeling, which falls outside of QC procedure scope has never been enabled onTracer-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 manualoperations. (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 FDGplus 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) Demonstrationof all other [89Zr]DFO-Pembrolizumab QC measurements on Tracer-QC.

Public Health Relevance Statement:
By expanding availability of ImmunoPET (Positron Emission Tomography imaging based on radio- labeled antibodies) to broad cancer population, proposed work enables timely and more educated treatment decisions that should lead to improved outcomes. Furthermore, by dramatically simplifying production of radio-labeled antibodies, this project enables further research in ImmunoPET field as directed by the Cancer Moonshot Initiative Blue Ribbon Panel report.

Project Terms:

Phase II

Contract Number: 9R44AI162202-02A1
Start Date: 1/15/2024    Completed: 12/31/2026
Phase II year
2024
Phase II Amount
$1,000,000
ImmunoPET Imaging allows visualization of biological processes in the body via radiolabeled monoclonal antibodies(mAb's) with Positron Emission Tomography (PET). ImmunoPET has proven to be a groundbreaking innovation yieldingactionable medical information that is not otherwise obtainable in many disease areas. However, ImmunoPET imaging isonly available at select academic centers limited by complexity of production of short-lived Zr-89-radiolabeled antibodies.,which prevents access of ImmunoPET to the majority of patient population and to clinical trial utilization. To address this barrier, Trace-Ability will develop Tracer-ONE - compact and affordable automation of the entire [Zr-89]mAb production procedure including radio-labeling, QC and immunoassay with results available before the PET scan.Production staff will need only to install a kit, add the radionuclide, initiate the process and return to collect the productalong with QC report. Such solution will enable any facility with limited staff and budget to start producing ImmunoPETtracers in a scalable, standardized, safe and GMP-compliant manner. Key new capabilities needed for Tracer-ONE have been demonstrated in Phase I including radiolabeling,immunoreactivity assay and most QC tests. Phase II is designed to deliver a fully-functional system suitable for cGMPproduction of a variety ImmunoPET tracers for clinical use. To maximize the immediate impacts of the project, we chosethe HIV application of ImmunoPET, currently limited to a single location in the US. To demonstrate the scalability ofTracer-ONE, we will sequentially enable two HIV ImmunoPET tracers starting with [Zr-89]VRC01. Specific Aim 1 Develop fully automated [Zr-89]VRC01 radio-synthesis starting with [Zr-89]oxalate and a disposablekit and yielding [Zr-89]VRC01 that meets all requirements for clinical use. Specific Aim 2 Develop fully automated [Zr-89]VRC01 quality control including immunoreactivity. The deliverable of this aim is to design a disposable kit andcorresponding protocol to enable all measurements required prior to clinical use of [Zr-89]VRC01. Specific Aim 3 OptimizeTracer-ONE for fully automated production of [Zr-89]VRC01 for clinical use. The ultimate deliverable of this aim isacceptance of the system's performance by UCSF quality and regulatory groups. Specific Aim 4 Demonstrate efficientexpansion of established Tracer-ONE capabilities to another HIV ImmunoPET tracer. The deliverable of this aim is a fullyautomated radiosynthesis and QC process on Tracer-ONE qualified for a second HIV tracer at UCSF and meeting the sameacceptance criteria as [Zr-89]VRC01. The outcome of the project is principal enablement of a capability that does not exist today - routine ImmunoPETtracer production across a diverse range of products leading to broad availability of ImmunoPET imaging to Americanpatients in AIDS, cancer, arthritis and other disease areas. In additional to diagnostic value, broad availability ofImmunoPET will increase the effectiveness of clinical trials and availability of new therapies and the percentage of patientsthat respond to therapies.

Public Health Relevance Statement:
ImmunoPET has proven to be a groundbreaking innovation yielding actionable medical information that is not otherwise obtainable in many disease areas. This project will enable nationwide availability of ImmunoPET by delivering the first-ever fully-automated production platform that can support a wide diversity of ImmunoPET tracers. HIV ImmunoPET was chosen for demonstration of this enabling platform due to the value of the imaging information coupled with it currently being limited to a single US site.

Project Terms: