Evergreen Theragnostics, Inc. has announced the initiation of its Phase II clinical trial, CCK2-VIEW, evaluating 68Ga-EVG321 in patients with small cell lung cancer (SCLC) within the European Union. This follows the European Medicines Agency (EMA) approval to commence recruitment (EUCT ID # 2024-514584-25-00). The trial aims to assess the potential of 68Ga-EVG321 as a diagnostic and theranostic agent targeting CCK2R, a protein highly expressed in SCLC cells.
Radioligand Therapy for SCLC
Radioligand therapies are emerging as a significant treatment modality across various tumor indications. These therapies combine medical isotopes with targeted therapeutics, facilitating cell-specific ablation by delivering ionizing radiation directly to diseased tissues. Additionally, they allow for non-invasive, whole-body quantification of tumor targets, aiding in the identification of patients most likely to benefit from treatment.
James Cook, CEO of Evergreen Theragnostics, stated, "We are excited to begin recruitment for our trial in this very important patient population. 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."
CCK2-VIEW Trial Design
The CCK2-VIEW trial is a multi-center, open-label, non-randomized Phase II imaging trial. It utilizes 68Ga-EVG321, a peptide-based radioligand imaging agent, administered to patients with SCLC. The primary objective is to quantify measurements of 68Ga-EVG321 radioactivity and its whole-body distribution at multiple time points. This data will serve as the foundation for theragnostic applications targeting CCK2R.
Potential of CCK2R Targeting
CCK2R is a protein found on the surface of tumor cells in small cell lung cancer, with studies suggesting that approximately 40-60% of all SCLC cases express CCK2R. Targeting CCK2R represents a promising avenue for radioligand therapy drug development.
Dr. Thomas Reiner, CSO of Evergreen Theragnostics, added, "CCK2R represents a significant, untapped opportunity for radioligand therapy drug development. 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 and 177Lu-EVG321
68Ga-EVG-321 is designed as a diagnostic agent targeting CCK2R, enabling patient selection via PET imaging. It is paired with 177Lu-EVG321, a radiotherapeutic designed to deliver Lutetium-177, a beta-emitting radioisotope, to solid tumors expressing CCK2R.
Addressing Unmet Needs in SCLC
Small cell lung cancer is an aggressive malignancy characterized by rapid growth and early metastasis. It accounts for 10-15% of all lung cancer cases, with a median survival of just 14 months post-diagnosis. Lung cancer remains a leading cause of cancer mortality globally, and SCLC contributes significantly to this burden. The development of novel therapies, such as radioligand therapies targeting CCK2R, is crucial to improving outcomes for patients with this aggressive disease.
