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.
For further information please contact:
Phone: +1 310 645 1211
Optimum Strategic Communications
Mary Clark, Charlotte Hepburne-Scott, Zoe Bolt
Phone: +44 203 882 9621
ImaginAb is a clinical stage, revenue-generating global biotechnology company developing the next generation of imaging agents and radiopharmaceutical therapy (RPT) products through its proprietary minibody and cys-diabody platforms. The lead candidate 89Zr crefmirlimab berdoxam (CD8 ImmunoPET™) imaging agent is currently in Phase II clinical trials and has been licensed by numerous pharmaceutical and biotech companies for use in imaging within their immunotherapy clinical trials, primarily in oncology.
ImaginAb’s vision is to transform patient care, and help people live better and healthier lives. For more information visit www.imaginab.com
About 89Zr crefmirlimab berdoxam (CD8 ImmunoPET™)
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.
About Melanoma Research Alliance (MRA)
The Melanoma Research Alliance (MRA) stands as the largest non-profit funder of melanoma research. Founded in 2007 by Debra and Leon Black, MRA’s mission is to end suffering and death due to melanoma by advancing the world’s most promising science and research. MRA provides critical funding for melanoma cancer research that propels advances in prevention, diagnosis, treatment, metastasis, and survivorship. MRA-funded researchers have been behind every major breakthrough in melanoma research. Since MRA’s inception, more than 15 new therapeutic approaches for melanoma have earned FDA approval. MRA is recognized as one of the most fiscally efficient non-profits in the country. Because MRA’s Founders’ generously cover 100% of MRA’s administrative and operating costs, every dollar donated is invested directly into MRA’s scientific and research program. For more information, please visit: www.CureMelanoma.org.