Novel, first-in-class radiopharmaceutical targeting a hallmark of the solid tumor microenvironment
December 22, 2025, Boston, MA – Lumina Pharmaceuticals, a clinical-stage radiopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for CM500. Lumina will proceed with a Phase 0 clinical study of [68Ga]CM500 and [64Cu]CM500, two PET imaging agents that bind to fibrin, a protein abundant in the microenvironment of solid tumors but not found in healthy tissue.
[68Ga]CM500 and [64Cu]CM500 are the PET imaging diagnostic half of a radiotheranostic pair Lumina is developing that binds to fibrin for the detection and treatment of solid tumor cancers. CM500 is a cyclic peptide containing radiopharmaceutical with optimized pharmacokinetics for target uptake and rapid background clearance. CM500 builds on previous work with an early generation fibrin binding PET agent, [Ga68]FBP8, which has been shown to detect primary and metastatic lesions in patients with gastric cancer. With CM500, Lumina has designed an agent with the same specificity coupled with the ideal properties for radioligand therapy. In radioligand therapy the PET imaging isotopes [64Cu] and [68Ga] are replaced with isotopes that emit radiation, such as beta or alpha particles, that can kill surrounding tumor cells.
“Our approach of binding to fibrin to deliver radioligand therapy to solid tumors has the potential to address areas of unmet need in multiple cancer indications and improve patient outcomes. Fibrin is a hallmark of the tumor microenvironment, making it an ideal binding target for the delivery of a pan-cancer radioligand therapy”, said Lumina’s CEO, Cara Ferreira, Ph.D. “CM500 represents a novel, first-in-class targeted radiopharmaceutical.”
The PET imaging study will investigate the biodistribution and dosimetry of [68Ga]CM500 and [64Cu]CM500 and enroll up to 40 subjects, including patients with certain solid tumor cancers such as colorectal, lung, gastric, kidney, and others. Results from the study will be used to de-risk the development of the therapeutic half of the radiotheranostic pair by informing which solid cancer indications to be included in the clinical development plan for the radioligand therapy.
Ferreira noted, “FDA clearance to proceed with the CM500 imaging trial marks a significant milestone for Lumina, demonstrating our capability to efficiently translate radiopharmaceuticals into the clinic. As we move forward with the development of our first-in-class radioligand therapy, the results from this trial expected later in 2026 will provide a wealth of validating and de-risking human data.”
About CM500 and fibrin binding radioligand therapy
Lumina’s lead asset is a potential pan-cancer radioligand therapy (RLT) theranostic pair, targeting a hallmark of the tumor microenvironment of solid tumors. Cancer is often referred to as ‘the wound that does not heal.’ When a tumor grows beyond about a millimeter in size, neovascularization is required to supply oxygen and nutrients. These new vessels are abnormal, with increased vascular permeability that results in extravascular coagulation and accumulation of fibrin within the tumor microenvironment.
The reliable abundance of fibrin in the microenvironment of tumors including metastatic lesions and its absence in healthy tissue makes it an ideal target for radioligand therapy. Fibrin is observed throughout the tumor environment as a ‘nest’ like mesh surrounding individual tumor cells and tumor cell clusters. Fibrin’s presence has been extensively reported in numerous solid cancers including lung, colorectal, kidney, breast, pancreatic, head & neck, ovarian, gastric and others.
About Lumina Pharmaceuticals
Lumina Pharmaceuticals is a clinical-stage radiopharmaceutical company distinguished by its innovative technology that targets novel biomarkers that are abundantly present in solid cancers yet largely absent in healthy humans. Lumina’s lead asset is a novel radioligand therapy (RLT) theranostic, targeting a hallmark of the tumor microenvironment of solid tumors. Led by industry-leading scientists and experienced executives, Lumina is committed to improving human health through its diagnostic and therapeutic radiopharmaceutical pipeline.
This clinical study is funded in part by the National Cancer Institute under Award Number R44CA275590. The content of this release is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.