On May 28, 2025 Aktis Oncology, Inc., an oncology company focused on unlocking the breakthrough potential of targeted radiopharmaceuticals for patient populations not addressed by existing platform technologies, reported that it has initiated clinical development of AKY-1189 in its Phase 1b clinical trial for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC), triple negative breast cancer (TNBC) and potentially other Nectin-4 expressing tumors (Press release, Aktis Oncology, MAY 28, 2025, View Source [SID1234653460]).
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Nectin-4 is a cell-surface protein highly expressed in several solid tumors with limited expression in normal tissues, making it an attractive target for precision oncology therapies. NECTINIUM-2 is a Phase 1b clinical trial that will enroll mUC patients during dose escalation, followed by dedicated expansion cohorts in mUC, TNBC and other Nectin-4 expressing tumors, including but not limited to lung, colorectal and cervical cancers. The trial is expected to enroll approximately 150 patients and patients will receive up to six doses of [225Ac]Ac-AKY-1189. The multi-center study is being conducted in the U.S.
"Advancing the first product candidate from our proprietary miniprotein radioconjugate platform into Phase 1b clinical development in the U.S. is an important milestone for Aktis," said Akos Czibere, MD, PhD, Chief Medical Officer of Aktis Oncology. "Data presented to date demonstrates AKY-1189’s substantial tumor uptake in patients with various Nectin-4-expressing tumor types with limited exposure to normal tissue, suggesting potential for a wide therapeutic window in addressing high unmet need patient populations."
Data presented in an oral plenary session at the 2024 EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics demonstrated that AKY-1189 has a promising biodistribution profile with significant tumor uptake in patients with mUC, metastatic breast cancer, non-small cell lung cancer carcinoma, colorectal cancer and cervical cancer. These data marked the first report of a Nectin-4 targeted radiopharmaceutical candidate to demonstrate significant tumor uptake in patients and support the progression of AKY-1189 into therapeutic clinical studies, potentially offering a new treatment option for patients with these challenging solid tumor types.
"Radiopharmaceutical therapy targeting Nectin-4 is a highly attractive strategy, enabling the targeted delivery of radiation directly to tumor cells. Building on the success of Nectin-4-directed antibody-drug conjugates, this approach combines imaging with therapeutic innovation to potentially personalize treatment for advanced urothelial cancer and other solid tumors. The NECTINIUM-2 trial, evaluating the safety and efficacy of the Nectin-4 radiopharmaceutical, [225Ac]Ac-AKY-1189, is a key step forward in advancing this concept," said Matthew Galsky, M.D., co-director of the Center of Excellence for Bladder Cancer at The Tisch Cancer Institute at Mount Sinai Hospital in New York.