Advancing the PSMA-PET Standard of Care

OVERVIEW

Prostate cancer is the most common type of cancer (aside from skin) in American men with 13 out of every 100 being diagnosed with the disease during their lifetime.1,2Prostate-specific membrane antigen (PSMA) is a transmembrane protein that is expressed in high levels in prostate cancer cells. Due to its location on the cell surface, PSMA is a popular target for imaging to identify the presence of prostate cancer and to deliver drugs directly to the cancerous cells3.

A PSMA-PET scan is a powerful molecular imaging technique that can accurately localize prostate cancer and assess the level of a tumor’s PSMA expression. There are currently two USFDA and one EMA-approved PSMA-PET agents that are widely used in both clinic and trials. In early 2022, the USFDA approved the first targeted radioligand therapy, 177Lu-PSMA-61, for use in men with metastatic prostate cancer whose tumors overexpress the PSMA protein4.

Invicro is a full-service CRO providing industry-leading PSMA-PET solutions from radiochemistry development to preclinical and Phase 0-IV clinical trials. We support researchers that develop PSMA-targeted prostate cancer therapeutics or multi-specifics, and groups using PSMA expression as a biomarker for patient selection, and treatment response in prostate cancer clinical trials. Invicro advances PSMA-PET standard of care by combining advanced image analytics and artificial intelligence with standard PET SUV readouts to ensure you are receiving the most meaningful data from your images. Invicro has overseen more clinical PSMA-PET scans (>3,600) than most imaging CROs and is one of the only organizations to support an FDA submission combining AI and quantitative PET.

Our full-service PSMA-PET solutions include:

  • Complete global core lab support for Phase 0-III clinical trials
  • Radiology expertise for study design, image analysis and sub-specialty reads (PCWG3)
  • Advanced analytical tools for whole body image quantification to estimate disease burden, lesion localization and response to therapy
  • Radiochemistry development and expert guidance on PSMA ligand access and utilization, including external manufacturing support
  • Preclinical solutions for discovery research
  • Extensive experience with Regulatory filing support (e.g., IND-enabling support)

 

 

Clinical Imaging Core Lab

Invicro supports early-phase, single-site and late phase, multi-site global clinical studies with a unique blend of scientific, medical, and operational practices. We are the leading imaging CRO in clinical PSMA-PET scans with over 3,600 managed. Invicro advances the PSMA-PET standard-of-care analysis and maximizes clinical data with our clinical solutions, including:

  • First-in-human, single-site clinical trial support
  • Study design and consultation
  • Experience with eligibility and efficacy reads including VISION and RECIST 1.1/PCWG3
  • Late stage, global multi-center clinical trial support with response criteria reads
  • Advanced image analytics combining PET SUV readouts with AI
  • Safety profile and therapeutic efficacy studies

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RECIST 1.1 Radiomics Exploration in MINT

RECIST 1.1 Target Lesion Area Calculation in MINT

 

PSMA-PET Medical and Radiology Expertise

Invicro’s medical team is led by Dr. Phillip Kuo, an internationally recognized expert in PSMA-PET and is comprised of highly qualified readers and experienced MDs to help scale any project. Our offerings span from study design support to implementing read criteria such as PCWG3 for global clinical trials. Our existing and functional RECIST 1.1, PCWG3 and VISION-type reads are coded in MINT to allow for custom configuration to support your project goals. In addition, Invicro’s partners include multiple radiology groups that provide highly specialized reads to accommodate all project needs.

MINT Lesion Report – Response Evaluation 

Image Analysis + Artificial Intelligence

Invicro’s advanced analytical tools specialize in whole body image quantification to estimate disease burden, lesion localization, and response to therapy. As one of the only imaging CROs to support an FDA submission using artificial intelligence (AI) and quantitative PET, our in-house team has experience supporting preclinical and clinical PSMA-PET imaging and therapeutic agent studies.

Our solutions span from customized and automated image processing techniques using deep learning to dosimetry for safety profile analysis. We build validated core lab workflows to meet the needs of your specific PSMA trials. Recently, Invicro and Telix Pharmaceuticals advanced a partnership to develop an AI platform to accompany Telix’s PSMA-PET imaging agent, Illuccix® – known as TelixAITM. TelixAITM seeks to increase the efficiency and reproducibility of clinicians’ imaging assessments using advanced analysis capabilities with an initial focus on prostate cancer.

Our advanced image analytic solutions include:

  • Algorithms for automated and semi-automated lesion identification
  • Image quality control and co-registration
  • Preclinical dosimetry safety studies and clinical dosimetry analysis workflows
  • Extrapolating dosimetry of therapeutics from imaging agents
  • Expertise across various species

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PSMA Radiochemistry Development and External Manufacturing

Invicro’s novel and commercial PSMA-PET ligand capabilities span from radiochemistry support for preclinical to first-in-human clinical studies and GMP production, utilizing our CMO partners.

Invicro works with the following isotopes:

  • Lu177
  • Ga68/ Lu177
  • Ga68 labeled PSMA-617
  • Ga68 labeled PSMA-I&T
  • Ga68 labeled small molecules for PSMA targeting
  • Additional Isotopes for PSMA imaging/therapy (In111, Lu177, Ac225, Cu64)
  • 18F/18F-AlF4 chelation
  • 11C

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Preclinical PSMA-PET Solutions

Bringing new PSMA-PET imaging agents and therapeutics to market requires strong preclinical data. Invicro specializes in end-to-end preclinical solutions to drive discovery and streamline clinical translation of PSMA- targeted drugs.

Solutions include:

  • Study design and consultation
  • Establishment of radiolabeling methods followed by in vivo biodistribution and efficacy (PSMA radiotherapy studies using Ac225 and Lu177) in rodents
  • Use of in vitro techniques (FACS analysis, radioligand binding assays and uptake, internalization, and retention assays) as methods of screening multiple compounds
  • Use of imaging to assess tumor targeting, kinetics and biodistribution (Ga68 and 18F PET imaging, 177Lu SPECT imaging, Cut and Count biodistribution and mass dose analysis)
  • Development of theranostic pairs to radiolabel PSMA small molecules for imaging and therapy of prostate cancer
  • Validate and use [68Ga]PSMA-11 imaging to assess the therapeutic efficacy of a PSMA-targeted immuno-oncology agent in pre-clinical prostate tumor models (22Rv-1, LNCaP, PC3-PSMA and RM-1)

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Theranostic development of a PSMA targeting small molecule for Prostate Cancer

Invicro's PSMA Experts

Scientific and Medical Services

Phillip Kuo, M.D., Ph.D. | Senior Medical Director

Dr. Phillip Kuo is board-certified in Internal Medicine and Radiology with a special certification in Nuclear Medicine. Prior to taking on the role of Senior Medical Director for Invicro, he was Chief of Nuclear Medicine at a university medical center for 10 years. Dr. Kuo has more than 100 publications and has served as principal investigator and co-principal investigator on multiple NIH grants and investigator-initiated trials. His experience includes design and supervision of phase I-III clinical trials including theranostics with PET, SPECT, MRI, and radiotherapeutics as well as leading the VISION read development. Dr. Kuo’s experience also includes participation in USFDA and EMA meetings for regulatory approval. As a reader for clinical trials, he has reviewed over ten thousand scans for oncology or neurology.

 

Gisela Montgomery, M.D., Ph.D. | Medical Director

Dr. Gisela Montgomery has seven years of national and international experience in phase I-IV breast cancer clinical imaging trials and has published several scientific peer-reviewed manuscripts in journals, such as Radiology and European Radiology, as first author. She has expertise in protocol design, statistical analysis, imaging evaluation, oncology response criteria (including RECIST 1.1 and PWCG3), regulatory affairs, artificial intelligence, and business development.

 

Sean Carlin, Ph.D. – Principal Scientist

Dr. Sean Carlin has >25 years of pre-clinical and translational radiopharmaceutical research experience and is an expert in radiation biology. Dr. Carlin also has a particular emphasis on the design and evaluation of radioligands and advanced pre-clinical nuclear imaging techniques. Dr. Carlin has more than 100 peer-reviewed publications and has served as principal investigator and co-principal investigator on multiple US federal grants and sponsored projects. Prior to joining Invicro, he held faculty positions at Weill-Cornell Medical Center, Memorial Sloan Kettering Cancer Center, and The University of Pennsylvania. Dr. Carlin holds a PhD in Molecular Radiopharmacology from the University of Glasgow, Scotland.

Operations

Edward Hogan | Executive Vice President, Clinical Operations

Mr. Edward Hogan oversees the Clinical Services team including Project Management, Imaging Services, Data Management and Reader Management for early and late phase clinical trials at Invicro. Mr. Hogan has over twenty-nine years of experience in clinical research, managing and executing Phase 0-IV imaging trials in both the Pharmaceutical and CRO space. He brings more than twenty-one years of experience in managing clinical operations, including extensive experience leading cross-functional teams, including Operations (Project, Image and Data Management), Engineering (Development and Validation) and Medical and Scientific Services. Mr. Hogan has progressive business experience in building and managing global cross-functional teams supporting clinical trials focusing teams on delivery, accountability, and customer satisfaction while driving quality and process improvements.

Beth Rodriguez, CNMT | Vice President, Project Management

Ms. Beth Rodriguez is responsible for the oversight of the project management team, ensuring adequate resource management, coordination of timelines and client communication. Ms. Rodriquez has more than fifteen years of international clinical research and 20+ years of imaging experience. Ms. Rodriquez has successfully managed over 100 large global clinical studies during her career which include various oncology indications ranging from Ph I to Ph III. Beth has extensive experience managing and mentoring remote internal and external global team members across service lines. She has participated in and supported regulatory and client audits (FDA, PMEA). Prior to joining Invicro, Ms. Rodriquez was the Operational Head for 5+ Sponsor Governance Committees.

Image Analysis

Elliot Greenblatt, Ph.D. – Principal Scientist, Head of Advanced Special Projects

Dr. Elliot Greenblatt joined Invicro after receiving his Ph.D. in Mechanical Engineering from The Massachusetts Institute of Technology (MIT) in 2015. Dr. Greenblatt has 16+ years of experience in medical image analysis and medical device design. He specializes in developing classical and ML techniques to interpret medical images and in the development of new hardware and software prototypes to image and monitor disease. Prior to joining Invicro, Dr. Greenblatt developed software and hardware to aid the acquisition and analysis of pulmonary functional images. As the current Principal Scientist, Head of Advanced Special Projects, he leads the development and execution of many machine-learning projects on the image analysis team.

Vanessa Kelly, Ph.D. – Director, Oncology & Systemic Disease Image Analysis

Dr. Vanessa Kelly leads the Clinical Oncology and Systemic Diseases Image Analysis team. Dr. Kelly has 12 + years’ experience in clinical and preclinical imaging, biomarker, and drug development in oncology and systemic diseases. During her time at Invicro, Dr. Kelly has worked on several pre-IND programs within the Discovery Research team (In-111/Ac-225 theranostic pairs; Lu-177 targeted radiotherapy; Kelly et. al, Theranostics 2020). More recently, Dr. Kelly has been leading the clinical oncology and systemic disease image analysis team to design, build, and execute image analysis workflows for clinical trials. Specifically, image analysis workflows that incorporate PSMA-PET, FDG-PET, planar-dosimetry, hybrid-dosimetry, and several others. Her role covers software development, management, cross-department collaboration, scientific oversight, and sponsor support.

Contact Us for More Information!

Sources

  1. https://www.cdc.gov/cancer/prostate/statistics/index.htm
  2. https://www.cdc.gov/cancer/prostate/basic_info/risk_factors.htm
  3. Zukotynski K and Kuo PH. 18F-DCFPyL PET/CT in men with prostate cancer. Radiology. 2022 Jul (online); doi.org/10.1148/radiol.221536
  4. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-disco-burst-edition-fda-approval-pluvicto-lutetium-lu-177-vipivotide-tetraxetan-treatment-adult