ImaginAb Launches Phase II C-IT Neo Trial using CD8+ Cell Imaging to Investigate Neoadjuvant Immunotherapy

ImaginAb Launches Phase II C-IT Neo Trial using CD8+ Cell Imaging to Investigate Neoadjuvant Immunotherapy

Los Angeles, USA and New York, USA, December 14, 2022 – ImaginAb Inc., a global biotechnology company focused on developing 89Zr crefmirlimab berdoxam (CD8 ImmunoPET™) imaging agent and radiopharmaceutical therapy (RPT) products, in collaboration with Memorial Sloan Kettering Cancer Center (MSK) and Melanoma Research Alliance (MRA), has launched an investigator-initiated Phase II trial to explore the efficacy and safety of neoadjuvant immune checkpoint inhibitor treatment of stage III surgically resectable melanoma through use of CD8 ImmunoPET.

The trial, named ‘C-IT Neo’, will use ImaginAb’s CD8 ImmunoPET to investigate the effectiveness of neoadjuvant treatment prior to surgery. Information on the CD8+ cell status of the patient is available before and after neoadjuvant treatment. If the outcome of the trial demonstrates positive results regarding the utility of knowing CD8+ status prior to surgery, the current standard of care may change to allow patients to continue to surgical resection at an earlier stage.

In addition, autoradiography will be performed on resected surgical specimens to assess the correlation between CD8+ PET signal and CD8+ cell density by immunohistochemistry (IHC).  This will provide important information for ImaginAb as it continues its clinical development pathway for CD8 ImmunoPET.

Details of the trial can be found on clinicaltrials.gov under the identifier NCT05289193 

Commenting on the news, Ian Wilson, Chief Executive Officer of ImaginAb, said:

“We are very pleased to be collaborating with MSK and MRA on this important study. This is the first investigational use of CD8 ImmunoPET in a neoadjuvant setting and aims to provide insight into whether the neoadjuvant treatment has been effective prior to surgery.”

The C-IT Neo trial begun enrollment with its first patient enrolled (FPI) on June 21, 2022. The study aims to enroll 28 patients over the next 1-2 years and will last 3-4 years.   Imaging will be performed at MSK in Manhattan and patients will be serially enrolled.