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SPRINGFIELD, N.J., Oct. 18, 2024 -- Evergreen Theragnostics, Inc., a company at the forefront of radiopharmaceutical development, has announced the commencement of its clinical trial for 68Ga-EVG321, a treatment aimed at small cell lung cancer (SCLC) patients, following the European Medicines Agency’s (EMA) approval for recruitment in the European Union (EUCT ID # 2024-514584-25-00).

Radioligand therapies (RLTs) are showing great promise in treating various tumors and are regarded as a burgeoning sector in cancer treatment. These therapies leverage the dual capabilities of medical isotopes and targeted medication to selectively destroy tumor cells by directing ionizing radiation precisely to cancerous tissues. Additionally, they enable comprehensive, non-invasive measurement of tumor targets, which helps identify patients who are likely to respond to the treatment. The 68Ga-EVG321 molecule is designed to target CCK2R, a receptor found in high concentrations in SCLC, offering a potentially powerful means of delivering therapeutic agents specifically to tumors.

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James Cook, the CEO of Evergreen Theragnostics, expressed enthusiasm about the new trial, emphasizing the significance of creating innovative treatments for SCLC patients. He noted that the EMA’s approval underscores the urgency of extending radioligand therapies to new medical indications. He also highlighted that this Phase II trial is a testament to the company's commitment to pioneering a variety of unique RLTs.

The newly launched CCK2-VIEW trial involves the administration of the peptide-based radioligand imaging agent 68Ga-EVG321 to SCLC patients. This multi-center, open-label, non-randomized Phase 2 study aims to measure the distribution and radioactivity of 68Ga-EVG321 in the body at different time points. This data will be crucial in developing applications for theragnostics targeting the CCK2R receptor.

Dr. Thomas Reiner, the Chief Scientific Officer at Evergreen Theragnostics, highlighted the untapped potential of CCK2R in radioligand therapy development. He indicated that the company is eager to expand its clinical trial portfolio, including therapeutic studies involving 177Lu-EVG321. If successful, the combined use of 68Ga and 177Lu in EVG321 treatment could provide a significant new option for SCLC patients.

68Ga-EVG321 serves as a diagnostic tool targeting CCK2R, utilizing PET imaging for patient selection. It is paired with 177Lu-EVG321, a therapeutic agent that delivers the beta-emitting radioisotope Lutetium-177 to solid tumors expressing CCK2R. CCK2R is a protein located on the surface of tumor cells in SCLC and other cancers.

Small cell lung cancer is known for its rapid growth and tendency to spread early. It accounts for about 10-15% of all lung cancer cases, with a median survival time of just 14 months post-diagnosis. Lung cancer remains a leading cause of cancer-related deaths globally, and SCLC comprises a significant portion of these cases. Evidence suggests that 40-60% of SCLC cases express the CCK2R protein.

Evergreen Theragnostics, Inc., established in 2019, focuses on enhancing cancer treatment options through radiopharmaceuticals. The company engages in Contract Development and Manufacturing (CDMO) services and is involved in the discovery and commercialization of proprietary products. Headquartered in Springfield, NJ, Evergreen operates from a cutting-edge GMP radiopharmaceutical facility. The founding team brings a wealth of experience in radiopharmaceutical manufacturing, research, and clinical development.

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