Preclinical and preliminary clinical evidence indicates thatthe novel radiolabeled tracer 68Ga-OPS202, an sst antagonist with a highaffinity for sst2, has the potential to perform better than an sst agonist suchas 68Ga-DOTATOC because 68Ga-OPS202 binds to more sst receptor binding sitesthan sst agonists. This first-in-human Phase 1/2 study, included 12 patients with well-differentiated GEP-NETs. Based on the total numbers of detected malignant lesions, the optimal time window for the scan was determined to be between 1 and 2 h. The study shows that 68Ga-OPS202 is rapidly cleared from the blood, resulting in low background activity, especially in the liver and gastrointestinal tract.
“Even though the effective dose of 68Ga-OPS202 is comparableto other 68Ga-labeled somatostatin analogs, there are striking differencesconcerning its biodistribution and organ doses such as liver, gastrointestinaltract, pancreas, lung and spleen,” explains Damian Wild, MD, Ph.D., andUniversity Hospital Basel in Basel, Switzerland.
The lower organ doses and tracer uptake of 68Ga-OPS202,especially in the gastrointestinal tract and the liver, is clinically relevant,as it allows improvement of the imaging contrast (tumor-to-background ratios)and sensitivity for detecting primary tumor or liver metastases of GEP-NETs (asshown in comparison to 68Ga-DOTATOC in Phase 2 of the study, also published in the June JNM).
Important for patients is that 68Ga-OPS202 was welltolerated and did not raise any safety concerns.” 68Ga-OPS202 could be afavorable alternative to the current radiolabeled somatostatin agonists in usein the clinic for PET/CT imaging of neuroendocrine tumor patients. In addition,due to their enhanced binding properties, radiolabeled sst antagonists may open a new avenue for PET imaging and targeted radionuclide therapy in non-neuroendocrine tumor indications. In that sense, 68Ga-OPS202 is the ideal theranostic companion for 177Lu-OPS201 targeted radionuclide therapy.”
In March 2020, RadioMedix Inc. and its commercial partnerCurium announced that the US Food and Drug Administration (FDA) had grantedcopper Cu 64 dotatate injection a priority review. Copper Cu 64 dotatate is aPET diagnostic agent intended for somatostatin receptor (SSTR) expressingneuroendocrine tumors (NETs). If approved copper Cu 64 dotatate injection will be the first FDA approved Cu 64 labeled radiopharmaceutical for PET/CT imaging. In addition, this drug will provide an exciting new imaging agent for NET physicians, patients and caregivers. Curium is preparing to launch copper Cu 64 dotatate in Q3 of this year.
What are the Neuroendocrine Tumors Market Barriers?
· Treatment costs
· Need for novel therapeutics
· Need for targeted treatment regimen
What are the Neuroendocrine Tumors Market Drivers?
· Increase in research activities
· Increasing disease incidence
· Surge in a number of clinical studies