Phase 1 study evaluates distinct ²²⁵Ac and ¹⁷⁷Lu compounds in breast cancer and other solid tumors; data expected in late 2027

²²⁵Ac-A9-0642 is the first actinium-based GRPR-targeting compound to enter clinical evaluation with the potential to deliver enhanced efficacy compared to first-generation ¹⁷⁷Lu approaches

¹⁷⁷Lu-A9-0631 is a lutetium-based GRPR-targeting compound with best-in-class potential

Alpha-9 takes a modular approach to molecular engineering, holistically optimizing each component of a radiotherapeutic to design fit-for-purpose compounds

BOSTON and VANCOUVER, BC, Sept. 8, 2026 /PRNewswire/ — Alpha-9 Oncology, a clinical-stage radiotherapeutic company developing targeted cancer treatments, today announced 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.

“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.”

About Alpha-9 Oncology

Alpha-9 Oncology is a clinical-stage radiotherapeutic company developing compounds with first- and best-in-class potential to meaningfully improve treatment options for people living with cancer. The company is redefining radiotherapeutic development by utilizing a modular optimization platform across binder, linker, chelator, and isotope to ensure a fit-for-purpose combination for each target and indication. Alpha-9’s clinical-stage radiotherapeutic compounds are optimized to maximize tumor retention and minimize healthy tissue exposure. For more information, please visit www.a9oncology.com.

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SOURCE Alpha-9 Oncology