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)..

新泽西州斯普林菲尔德，2024年10月18日/PRNewswire/--Evergreen Theragnostics，Inc.是一家临床阶段的放射性制药公司，专注于为癌症患者提供额外的治疗选择，在获得欧洲药品管理局（EMA）开始招募（EUCT ID#2024-514584-25-00）的批准后，很高兴地宣布在欧盟为小细胞肺癌患者开放其68Ga-EVG321试验。。

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.

放射性配体疗法已成为具有多种肿瘤适应症的患者的重要治疗选择，并代表了一个迅速扩大的市场。通过结合医学同位素的力量和靶向治疗的精确度，这些类型的药物促进肿瘤靶标的细胞特异性消融，将电离辐射定位于患病组织。

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..

它们还允许对肿瘤靶标进行非侵入性全身定量，从而确定哪些患者将从治疗中受益。68Ga-EVG321靶向CCK2R，CCK2R已被证明在SCLC中高度表达，并有可能促进稳健的肿瘤特异性递送。。

'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.

EMA的反应不仅表明了为小细胞肺癌患者开发新疗法的重要性，而且还表明放射性配体疗法迫切需要扩展到新的适应症。

This Phase II study also validates Evergreen Theragnostics' innovative drug pipeline, which is built to deliver a suite of differentiated RLTs.'.

这项II期研究还验证了Evergreen Theragnostics的创新药物管道，该管道旨在提供一套差异化的RLT。

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..

CCK2-VIEW试验使用68Ga-EVG321，一种基于肽的放射性配体显像剂，用于小细胞肺癌患者。这是一项多中心，开放标签，非随机的2期成像试验。其目标是量化68Ga-EVG321放射性的测量及其在多个时间点在患者体内的全身分布，为针对CCK2R的诊断应用奠定基础。。

'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..

“CCK2R代表了放射性配体治疗药物开发的一个重要且尚未开发的机会，”Evergreen Theragnostics CSO Thomas Reiner博士补充道我们期待着进一步扩大我们的临床试验组合，包括177Lu-EVG321的治疗试验。如果成功，治疗不可知的68Ga/177Lu-EVG321对可以为小细胞肺癌患者提供新的希望。。

About 68Ga-EVG321

关于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.

68Ga-EVG-321旨在成为针对CCK2R的诊断剂，可将PET诊断用于患者选择。该分子与其放射治疗对177Lu-EVG321配对，该放射治疗对旨在将发射β的放射性同位素Lutetium-177递送至表达CCK2R的实体瘤。

CCK2R is a protein found on the surface of tumor cells in small cell lung cancer and other indications..

CCK2R是一种在小细胞肺癌和其他适应症的肿瘤细胞表面发现的蛋白质。。

About Small Cell Lung Cancer

关于小细胞肺癌

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.

小细胞肺癌是一种侵袭性肺癌，其特征在于主要在肺组织中发现的小圆形细胞的快速生长和早期扩散。小细胞肺癌约占所有肺癌病例的10-15%。诊断后的中位生存期仅为14个月。

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..

在全球范围内，肺癌是癌症死亡的主要原因，小细胞肺癌占这些病例的很大一部分。有证据表明，大约40-60%的小细胞肺癌表达CCK2R。。

About Evergreen Theragnostics, Inc.

关于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.

Evergreen Theragnostics专注于改进使用放射性药物的癌症患者的可用选择。该公司从事合同开发和制造（CDMO）服务以及专有产品的药物发现和商业化。Evergreen总部位于新泽西州斯普林菲尔德，拥有最先进的GMP放射性制药设施。

The company was founded in 2019 by a team that brings a strong track record in theragnostic radiopharmaceutical manufacturing, research, and clinical development..

该公司成立于2019年，其团队在不可知放射性药物的制造，研究和临床开发方面取得了良好的业绩记录。。