The first patient has been dosed at the Macquarie University Hospital in Sydney as part of a clinical trial to evaluate whether a drug can predict patient response to immuno-oncology therapy targeting a number of solid tumor types.
ImaginAb Inc. is a biotech company developing 89Zr crefmirlimab berdoxam (CD8 ImmunoPET) imaging agent and next generation radiopharmaceutical therapies (RPT).
ImaginAb announced the launch of its phase 2b iPREDICT trial in January this year, which is a part of its clinical development to support marketing approval for CD8 ImmunoPET. The trial is being conducted globally in the US, Australia, and Europe.
The phase 2b trial aims to assess predictive performance with its primary objective to evaluate the performance of CD8 ImmunoPET positron emission tomography/computed tomography (PET/CT) for predicting patient response to immuno-oncology therapy targeting melanoma, Merkell cell, renal cell carcinoma, non-small cell lung cancer, and other selected solid tumors.
The Olivia Newton John Cancer Research Institute in Melbourne, which is also manufacturing doses for the iPREDICT trial in Australia, delivered the first clinical dose to the Macquarie University Hospital for use by doctor Alison Zhang in the iPREDICT trial.
Transforming cancer care
Ian Wilson, chief executive officer at ImaginAb, said: “We are delighted to have reached this important clinical development milestone for ImaginAb as we move one step closer to our goal of helping to transform cancer care for patients.
“We are actively enrolling the iPREDICT trial over 22 clinical sites across Australia, Europe and the US. We would like to thank our local sponsor and contract research organization, Accelagen, who played a key role in the achievement of this milestone by facilitating smooth communication with our investigators and the sites across the two time zones.”
ImaginAb is a clinical stage, global biotechnology company developing the next generation of imaging agents and radiopharmaceutical therapy (RPT) products through its minibody and cys-diabody platforms.
The lead candidate CD8 ImmunoPET imaging agent is currently in phase 2 clinical trials and has been licensed by numerous pharmaceutical and biotech companies for imaging in their immunotherapy clinical trials, primarily in oncology.
CD8 ImmunoPET is a 89Zr-labelled minibody that has been designed to bind to the CD8 receptor on human T cells for quantitative, non-invasive PET imaging of CD8+ T cells. CD8+ T cells are the main effector cells involved in the immune response against tumor cells induced by immunotherapies and they also play a key role in multiple autoimmune diseases.
As such, quantitative imaging of CD8+ T cells is currently being researched to determine whether it may be used to diagnose the immune status of a patient, to measure the efficacy of immunotherapies and predict patient outcomes.