Another significant milestone achieved as ImaginAb continues clinical development of its CD8 ImmunoPET imaging agent
ImaginAb Inc., a market leading global biotechnology company, focused on developing next generation ImmunoPET imaging agents and radiopharmaceutical therapy (RPT), has today formally launched a Phase IIb “iPREDICT” trial, as it continues on its path to filing for marketing approval of its pioneering CD8 ImmunoPET agent (zirconium Zr-89-crefmirlimab berdoxam).
The Phase IIb trial, called ‘iPREDICT’ (NCT05013099), aims to assess ‘predictive’ performance, the ability to measure clinical response in patients to immuno-oncology therapy, and builds on the data from the company’s Phase IIa ‘BOT’ (Baseline On/Treatment) Trial, which completed enrollment last December.
Cancer types included in this Phase IIb study include Melanoma, Merkel Cell, Renal Cell, Non-Small Cell Lung Cancer and selected solid tumors.
The first patient has been imaged in the new trial with a target of enrolling 80 patients over 22 sites across US, Australia, and Europe. The study has received approval from national and local health authorities in the US and Australia and has approval pending for the first site in Europe. The first three sites, CARTI Cancer Center (Little Rock, Arkansas), the University of Washington (Seattle, Washington), and Hoag Cancer Center (Irvine, CA) are already open for enrollment.
There is growing evidence (www.pubmed.ncbi.nlm.nih.gov/8608507/ and www.nature.com/articles/nature13954) to suggest CD8+ tumor infiltrating lymphocytes (TILs) are an important biomarker for prediction of response to immunotherapies. This has been an important factor in how ImaginAb has designed the ‘iPREDICT’ trial, with ImaginAb setting “response prediction” at the heart of the trial.
Ian Wilson, CEO of ImaginAb commented:
“We are extremely excited to announce the launch of ‘iPREDICT’ as we continue on our clinical development path and goal to achieve FDA approval of our novel CD8 ImmunoPET agent”.
William Le, Vice President of Operations added:
“Following quickly on completing the recruitment of our Phase IIa BOT trial, it is extremely pleasing to already have recruited patients for our new ‘iPREDICT’ Phase IIb study. We expect to be in a position to announce further clinical sites and update recruitment to the trial in 2022”.