ImaginAb Announces new Clinical Trial at Hull University Teaching Hospitals NHS Trust to Investigate CD8 ImmunoPET in Patients with Renal Cancer and Malignant Melanoma

Los Angeles, California, USA, December 6th, 2022 – ImaginAb Inc., a global biotechnology company focused on developing 89Zr crefmirlimab berdoxam (CD8 ImmunoPET™) imaging agent and radiopharmaceutical therapy (RPT) products, today announces the start of a Phase II clinical trial at Hull University Teaching Hospitals NHS Trust in the UK. The trial, named PRETZCEL, 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 defence 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 Dr. 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.

Commenting on the trial, Ian Wilson, Chief Executive Officer 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.”

Professor Paul Hagan, Dean of the Faculty of Health Sciences at the University of Hull added:

“The University of Hull is focused on improving the health experiences and outcomes of people in our region and beyond. This trial aims to support clinicians and researchers to discover and advance improvements in diagnosis, treatment, and care of patients with renal cancer and malignant melanoma. The trial will bring together clinicians and scientists at the Hull York Medical School, the University of Hull and the Hull University Teaching Hospitals NHS Trust – drawing on their clinical research capabilities, expertise and facilities which include the Hull Health Trials Unit (HHTU) and the Hull Molecular Imaging Centres (HuMIC), a > £15 million investment by the Daisy Charity Appeal together with the University of Hull and the Hull University Teaching Hospitals NHS Trust,, developed to support radiotracer discovery and translational imaging at Hull. 

Trials such as this aim to demonstrate the capability of ImaginAb’s novel imaging agent to provide less intrusive readouts of immune cell trafficking in the body and have the potential to transform the care of patients while matching the right treatment to the right patient.”

Professor 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.”

Professor Nick Stafford OBE, Chairman of the Daisy Appeal Charity said:

“Over the last twelve years the Daisy Appeal Charity has raised more than £12 million for investments in PET-CT infrastructure in Hull and East Yorkshire. Bringing together the local NHS and the University has helped to create a comprehensive molecular imaging set-up and research program, which is now achieving significant national and international recognition for both its basic science and translational clinical research. The Charity is delighted that the PRETZCEL trial is taking place and is confident that this will be one of many forthcoming projects which will further enhance our reputation in this area of clinical imaging.”