Evergreen Theragnostics opens CCK2-VIEW, a Phase II small cell lung cancer clinical trial, in the European Union

SPRINGFIELD, N.J., Oct. 18, 2024 /PRNewswire/ -- Evergreen Theragnostics, Inc., a clinical-stage radiopharmaceutical company, focused on providing additional treatment options for cancer patients, is pleased to announce opening of its trial of ⁶⁸Ga-EVG321 for patients with small cell lung cancer in the European Union, after receiving approval by the European Medicines Agency (EMA) to start recruitment (EUCT ID # 2024-514584-25-00).

Radioligand Therapies have become an important treatment option for patients with several tumor indications and represent a rapidly expanding market. By combining the power of medical isotopes and the precision of targeted therapeutics, these types of medicines facilitate cell-specific ablation of a tumor target, localizing ionizing radiation to diseased tissues. They also allow for non-invasive, whole-body quantification of tumor targets, thereby identifying which patients will benefit from treatment. ⁶⁸Ga-EVG321 targets CCK2R, which has been shown to be highly expressed in SCLC, and has the potential to facilitate robust, tumor-specific delivery.

"We are excited to begin recruitment for our trial in this very important patient population," commented James Cook, CEO of Evergreen Theragnostics. "The EMA response suggests not only the importance of developing novel treatments for patients with small cell lung cancer, but also the need for radioligand therapies to branch out into novel indications with urgency. This Phase II study also validates Evergreen Theragnostics' innovative drug pipeline, which is built to deliver a suite of differentiated RLTs."

The CCK2-VIEW trial uses ⁶⁸Ga-EVG321, a peptide-based Radioligand imaging agent administered to patients with small cell lung cancer. It is a multi-center, open label, non-randomized, Phase 2 imaging trial. Its goal is to quantify measurements of ⁶⁸Ga-EVG321 radioactivity and its whole-body distribution in patients at several time points, forming the foundation for theragnostic applications targeting CCK2R.

"CCK2R represents a significant, untapped opportunity for radioligand therapy drug development," added Dr. Thomas Reiner, CSO for Evergreen Theragnostics. "We are looking forward to further expanding our clinical trial portfolio, including therapeutic trials with ¹⁷⁷Lu-EVG321. If successful, a theragnostic ⁶⁸Ga/¹⁷⁷Lu-EVG321 pair could offer new hope to patients with small cell lung cancer.

About 68Ga-EVG321

⁶⁸Ga-EVG-321 is intended to be a diagnostic agent targeted at CCK2R which enables the use of PET diagnosis for patient selection. This molecule is paired to its radiotherapeutic pair ¹⁷⁷Lu-EVG321, which is designed to deliver Lutetium-177, a beta-emitting radioisotope, to solid tumors expressing CCK2R. CCK2R is a protein found on the surface of tumor cells in small cell lung cancer and other indications.

About Small Cell Lung Cancer

Small cell lung cancer is an aggressive form of lung cancer characterized by the rapid growth and early spread of small, round cells found predominantly in lung tissues. Small cell lung cancer represents approximately 10-15% of all lung cancer cases. The median survival after diagnosis is just 14 months. On a global scale, lung cancer is a leading cause of cancer mortality, with SCLC representing a significant portion of these cases. There is evidence that approximately 40-60% of all small cell lung cancers express CCK2R.

About Evergreen Theragnostics, Inc.

Evergreen Theragnostics is focused on improving the available options for cancer patients using radiopharmaceuticals. The company is engaged in Contract Development and Manufacturing (CDMO) services as well as drug discovery and commercialization of proprietary products. Evergreen is headquartered in Springfield, NJ in a state-of-the-art GMP radiopharmaceutical facility. The company was founded in 2019 by a team that brings a strong track record in theragnostic radiopharmaceutical manufacturing, research, and clinical development.

For more information, please visit www.evergreentgn.com.

For further information, please contact:

James Cook

President & CEO

james.cook@evergreentgn.com

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SOURCE Evergreen Theragnostics, Inc.