ImaginAb Inc., which is focused on developing 89Zr crefmirlimab berdoxam (CD8 ImmunoPET) imaging agent and radiopharmaceutical therapy (RPT) products, is starting a phase II clinical trial.
The trial, PRETZCEL, which will take place at Hull University Teaching Hospitals NHS Trust in the U.K., will investigate ImaginAb’s investigational CD8 ImmunoPET agent in patients with melanoma or renal cell carcinoma.
CD8 ImmunoPET is a modified radioactive minibody developed as a first-in-class imaging agent, designed to bind to CD8+ T cells. CD8+ T cells play a key role in the body’s immune defense against a variety of diseases including certain cancers. CD8 ImmunoPET aims to provide target-specific imaging with the potential to predict, inform, monitor and enable treatment of cancers. Detection of CD8+ T cells reliably indicates if, when and where in the human body an immune response is mounted against cancer cells.
The trial’s lead investigator is Azeem Saleem, Reader in Clinical Oncology at Hull York Medical School at the University of Hull, Honorary Consultant at Hull University Teaching Hospitals NHS Trust, and clinical lead for the Hull Molecular Imaging Centres (HuMIC).
Trial set-up, data management and regulatory oversight are being provided by the Hull Health Trials Unit (HHTU) at the University of Hull. The trial will enroll a total of 12 patients with melanoma or renal cell carcinoma, where immuno-oncology therapies are approved.
Participants will receive the imaging agent twice, followed by a PET-CT scan after each injection. The aim of the trial is to investigate the reproducibility of CD8 ImmunoPET and metabolism analysis of the tracer. The trial is being undertaken as part of ImaginAb’s clinical strategy to seek regulatory approval of CD8 ImmunoPET as well as to support current and future immuno-oncology clinical trials by its pharma and biotech partners.
Ian Wilson, CEO of ImaginAb, said: “We are delighted to be working on this important trial with the Hull Molecular Imaging Centre team at the Hull York Medical School and the Hull Health Trials Unit – both at the University of Hull and Hull University Teaching Hospitals NHS Trust, which further demonstrates ImaginAb’s commitment to the development of CD8 ImmunoPET imaging to improve patient outcomes. By working with this new clinical site, we will be gathering additional data to support our clinical development pathway as we continue to work towards our goals of primarily achieving FDA approval, followed by approval across multiple geographies.”
Makani Purva, chief medical officer for Hull University Teaching Hospitals NHS Trust said: “Hull is quite rightly forging a real name and a reputation for itself as a leader in medical research and clinical trials. The start of the PRETZCEL trial marks another important step forward for our clinicians, our academics and ImaginAb working together, exploring the delivery of innovative, tailored care for people with cancer.
“Taking part in trials like this could be of huge significance to patients treated locally and around the world, and we are excited to be leading the way here in East Yorkshire.”