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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 . For further information, please contact: James Cook President & CEO [email protected] SOURCE Evergreen Theragnostics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SPRINGFIELD, N.J., May 21, 2024 /PRNewswire/ -- Evergreen Theragnostics, Inc., a clinical-stage radiopharmaceutical company, today announced that they have entered into a collaboration and licensing-agreement with the Innsbruck Medical University (MUI), a leading European research institution to advance the development of novel radiopharmaceuticals. The agreement covers the clinical development of EVG321, a novel radioligand therapy (RLT) for small cell lung cancer (SCLC), targeting the cholecystokinin 2 receptor (CCK2R). RLTs have surged into the clinic and represent a rapidly expanding market. By combining the power of medical isotopes and the precision of targeted therapeutics, these types of medicines allow for cell-specific ablation of a tumor target, thereby localizing ionizing radiation to diseased tissues. CCK2R has been shown to be highly expressed in SCLC, and has the potential to facilitate robust, tumor-specific delivery. "We are very pleased to announce this new collaboration with the Medical University of Innsbruck," commented James Cook, CEO of Evergreen Theragnostics. "For several years, the research groups of Univ. Prof. Dr. Irene Virgolini and Priv. Doz. Dr. Elisabeth von Guggenberg in Innsbruck have established themselves as key innovators in the RLT-field, and we are excited to be working with them on one of their lead programs – this was an easy choice to make." He added: "Especially in the realm of small cell lung cancer, novel therapies are urgently needed, and we are confident that EVG321 has the potential to significantly improve outcomes for cancer patients in this indication." Univ. Prof. Dr. Irene Virgolini, Medical University of Innsbruck, said: "Evergreen Discovery is a pioneer in the field of radiopharmaceuticals, and their team is looking back on an impressive record in bringing novel medicines to patients. We are delighted to be collaborating with them. In conjunction with their subject matter expertise and proven ability to translate new radioligand therapies, it is their exceptional sense of urgency to bring novel drugs to patients in need, making them such valuable partners for us." Over the next months, Evergreen intends to begin registration enabling therapeutic and diagnostic clinical trials for Lutetium-177 (177Lu) EVG321 and Gallium-68 (68Ga) EVG321. If successful, EVG321 could offer new hope to patients with small cell lung cancer. 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 . About Medical University of Innsbruck Medical University of Innsbruck has approximately 2,200 employees and around 3,400 students and, together with the University of Innsbruck, is the largest educational and research institution in western Austria and the regional university for Tyrol, Vorarlberg, South Tyrol and Liechtenstein. Medical University of Innsbruck is involved in numerous international educational and research programmes and networks. The research focuses on the areas Oncology, Neuroscience, Genetics, Epigenetics and Genomics as well as Infectious Diseases, Immunology & Organ and Tissue Repair. In addition to scientific research, Medical University of Innsbruck is also nationally and internationally very successful in the highly competitive field of research funding. For more information on Medical University of Innsbruck, please visit For further information, please contact: James Cook President & CEO james.cook@evergreentgn.com

A newly developed PET imaging agent has been found to be effective in identifying medullary thyroid cancer (MTC) in preclinical and clinical studies. The results of the studies indicate that the PET imaging agent may be a promising theranostic candidate for clinical use. A newly developed PET imaging agent has been found to be effective in identifying medullary thyroid cancer (MTC) in preclinical and clinical studies, according to research published in the January issue of The Journal of Nuclear Medicine. The results of the studies indicate that the PET imaging agent may be a promising theranostic candidate for clinical use. MTC is one of the rarest forms of thyroid cancer and accounts for approximately three percent of all cases. Since MTC originates from different cells than most thyroid cancers, different imaging and therapy targets are needed for these patients. "The cholecystokinin-2 receptor (CCK-2R) is overexpressed on most MTC cells and various compounds targeting CCK-2R have been developed over the past several years. Most of these compounds, however, have low metabolic stability, which is not ideal for radioligand therapy," noted Thomas Günther, PhD, pharmaceutical radiochemist at Stanford University in Stanford, California. "With a simplistic design modification to tackle instability issues, our team created multiple theranostic agents and sought to evaluate their effectiveness." In the study, three compounds (DOTA-CCK-66, DOTA-CCK 66.2, and DOTA-MGS5 external reference]) were each labeled separately with 64Cu, 67Ga, and 177Lu. CCK-2R affinity of each of the radiolabeled compounds was examined on MTC cells. All three compounds exhibited a high affinity, however, due to the more favorable in vitro properties overall of DOTA-CCK-66, DOTA-CCK-66.2 was excluded from further studies. Next, in vivo stability, biodistribution, imaging, and competition studies were performed on mice bearing a CCK-2R-expressing tumor. 68Ga-DOTA-CCK-66 was selected for proof-of-concept PET/CT application based on its overall in vitro and in vivo properties. Two MTC patients then underwent 68Ga-DOTA-CCK-66 PET/CT. The compound was well tolerated, showed a favorable biodistribution, and demonstrated high accumulation of activity in tumors. "Due to increased in vivo stability, our compound reveals favorable tumor uptake as well as an improved activity clearance from off-target tissues. This could result in enhanced lesion detection in PET imaging and additionally enable targeted MTC radioligand therapy," said Constantin Lapa, MD, director of nuclear medicine at University Hospital Augsburg, in Augsburg, Germany. Günther and Lapa added, "A significant outcome of our work is the notion that it is possible to optimize pharmacokinetics by chemical design. Analyzing weaknesses of existing compounds and then systematically addressing those to improve imaging and treatment is crucial for future clinical translation." This research was published online in November 2023. The authors of "Preclinical Evaluation of Minigastrin Analogs and Proof-of-Concept [68Ga]Ga-DOTA-CCK-66 PET/CT in 2 Patients with Medullary Thyroid Cancer" include Thomas Günther, Nadine Holzleitner, Roswitha Beck, and Hans-Jürgen Wester, Department of Chemistry, Chair of Pharmaceutical Radiochemistry, TUM School of Natural Sciences, Technical University of Munich, Garching, Germany; and Oliver Viering, Georgine Wienand, Alexander Dierks, Christian H. Pfob, Ralph A. Bundschuh, Malte Kircher, and Constantin Lapa, Nuclear Medicine, Faculty of Medicine, University of Augsburg, Augsburg, Germany.