October 17, 2023 — Radionetics Oncology, Inc., a clinical stage radiopharmaceutical company focused on the discovery and development of novel agents for the treatment of a wide range of oncology indications, is pleased to announce that the first subject has been dosed in its Phase 1 study of 68Ga-R8760.
Study R8760-101 (NCT05999292) is evaluating the safety and dosimetry of 68Ga-R8760, a first-in-class small molecule radioligand imaging agent being developed for patients diagnosed with adrenocortical carcinoma. 68Ga-R8760 was discovered by Radionetics Oncology for identifying melanocortin 2 receptor (MC2R)-expressing adrenocortical cancer lesions to select patients who may benefit from MC2R-directed radioconjugate therapy. The multi-center study is being conducted in the United States in collaboration with global leaders in the treatment of adrenocortical carcinoma.
“Adrenocortical carcinoma is a disease with a desperate need for new agents, as the last drug approved by the FDA was in 1970. MC2R is highly expressed on adrenocortical carcinoma tumors with limited expression in healthy tissue outside of the adrenal gland itself. Theranostic targeting of MC2R may provide a new approach for identifying and treating adrenocortical carcinoma,” said Dr. Gary Hammer, M.D., Ph.D., the Millie Schembechler Professor of Adrenal Cancer at the University of Michigan Rogel Cancer Center and scientific advisor to Radionetics Oncology.
“Starting this exciting clinical study is an important milestone and was achieved within two years of the founding of Radionetics Oncology,” said Brett Ewald, Chief Operating Officer. “Our team has a deep understanding of G-protein coupled receptors (GPCRs), leading to the identification of novel and compelling first-in-class imaging and therapeutic targets for oncology, such as MC2R. This coupled with our company’s chemistry, biology, and clinical expertise allows us to rapidly develop potent and selective radiopharmaceutical agents for clinical evaluation.” Radionetics Oncology is developing a pipeline of new radiopharmaceuticals against novel targets and plans to have three clinical programs by 2024.
68Ga-R8760 is a gallium-68-labeled small molecule radioligand conjugate that selectively binds with high affinity to MC2R, a highly expressed target on adrenocortical carcinoma. It is the first imaging agent developed to localize and identify MC2R-expressing tumors and is being developed to identify patients with adrenocortical carcinoma who may benefit from a MC2R-directed therapeutic agent that is also being developed by Radionetics Oncology. Adrenocortical carcinoma is a rare cancer of the adrenal cortex with limited treatment options, especially in the recurrent or metastatic setting. Despite significant research efforts, the median survival of patients with metastatic disease is less than 15 months.
For more information: www.radionetics.com