Launch of Granzyme B Targeted PET Imaging Biopharmaceutical Services Program for Immunotherapy Assessment of Patient in Clinical Trials

Boston, MA – March 29, 2024 – CytoSite Bio Inc, a leader in innovative biopharmaceutical services, is excited to announce the official launch of its Granzyme B Targeted PET Imaging Biopharmaceutical Services program for assessing immunotherapy efficacy. Building on its expertise in molecular imaging, CytoSite has completed a clinical study showing robust diagnostic performance of its advanced Granzyme B PET imaging agents. Cytosite’s flagship PET imaging agent, CSB-321, has received approval for its Investigational New Drug (IND) application. Furthermore, CytoSite's flexible IND and adaptive clinical trial structure are already being utilized by multiple sponsors, demonstrating the program's versatility and effectiveness in advancing immunotherapy research.

CSB-321 can be integrated into current or planned clinical trials  to improve confidence in clinical pipeline decisions. Example clinical uses include,  use in dose-ranging studies facilitates understanding of pharmacodynamic effects, and its uptake can be used to potentially predict Response Evaluation Criteria in Solid Tumors (RECIST) outcomes. Moreover, CSB-321 may allow for the early identification of target lesions responding to therapy, along with the monitoring of non-tumor granzyme B release and mitigation of adverse events (AEs). This comprehensive approach using PET imaging  has the ability to streamline the development and assessment of novel immunotherapies.

“The clinical data we have generated to date validates our belief that use of PET imaging to detect active Granzyme B has the potential to transform outcomes in immuno-oncology, autoimmune-mediated and inflammatory diseases,” said Dr Benjamin Larimer, PhD, Co-founder and CEO of CytoSite. “We are excited to bring Granzyme B PET imaging to the forefront of immunotherapy development. This collaboration allows us to expand our immunology imaging program, while continuing to develop novel radiopharmaceuticals to both detect and treat cancer.”

About CytoSite Bio

CytoSite Bio is developing novel radiopharmaceuticals that enable the quantification and modulation of immune activation to improve cancer immunotherapy. Our lead product detects active Granzyme B, the primary protein responsible for the killing of tumor cells by the immune system. The goal of our products is to enable individually optimized treatments for patients, and more rapid evaluation of new drugs and drug combinations, using non-invasive, whole-body PET imaging.

What is Granzyme B PET Imaging

Granzyme B is an enzyme released upon activation of immune cells to destroy harmful cells, including cancer. The development of a Granzyme B-targeted PET imaging radiotracer, such as CSB-321 from CytoSite Bio, could revolutionize the assessment of immunotherapy efficacy. This innovative approach allows for early measurement of immune system activation, providing a highly accurate and spatially localized assessment of responding versus non-responding lesions. Unlike the current standard methods that require months to evaluate therapy effectiveness, CSB-321 offers a rapid readout within 5-14 days after starting therapy. CSB-321 could empower pharmaceutical developers to make faster decisions and allocate resources more efficiently. CSB-321 is currently for research purposes only.

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