Evergreen Theragnostics has begun its trial of 68Ga-EVG321 for patients with small-cell lung cancer in the European Union after receiving approval from the European Medicines Agency (EMA) to start recruitment.

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," stated Cook.

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,” added Dr. Reiner.