On September 8, 2026 Alpha-9 Oncology, a clinical-stage radiotherapeutic company developing targeted cancer treatments, reported the dosing of the first 225Ac patient in its Phase 1 study evaluating 225Ac–A9-0642 and 177Lu-A9-0631, Alpha-9’s alpha and beta-emitting radiotherapeutic programs targeting gastrin-releasing peptide receptor (GRPR). GRPR is a solid tumor target with broad clinical potential in breast and other solid tumors.

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"Dosing the first patient in our Phase 1 GRPR trial represents a significant milestone in Alpha-9’s journey as we seek to deliver the next wave of radiotherapeutic breakthroughs," said Paul Blanchfield, Chief Executive Officer of Alpha-9. "We believe our holistically optimized, distinct GRPR compounds have the potential to provide meaningful benefit to those living with cancer. Running both 225Ac and 177Lu programs in parallel allows us to efficiently generate data and validate our modular optimization platform."

GRPR is an ideal radiotherapeutic target given its high expression across breast cancer and other solid tumors with high unmet need, and favorable expression profile in healthy organs. Imaging studies have shown the ability to effectively target GRPR-expressing tumors.

The Phase 1 study is designed to assess the safety, tolerability, dosimetry, and recommended dose for expansion of 225Ac-A9-0642 and 177Lu-A9-0631 in patients with GRPR-positive advanced or metastatic tumors. Alpha-9 will utilize its proprietary GRPR imaging compound, 68Ga-A9-6217, for patient selection. Data is expected in late 2027.

"Diagnostic imaging data generated with 68Ga-A9-6217 demonstrated excellent tumor targeting and limited healthy organ uptake," said Dr. Robert S. Meehan, Chief Medical Officer of Alpha-9. "Additionally, early results from access under compassionate use showed that 177Lu-A9-0631 was well tolerated in individuals with GRPR-positive tumors and we look forward to generating additional data for both our alpha- and beta-emitting compounds."

(Press release, Alpha9 Oncology, SEP 8, 2026, View Source [SID1234670615])