Advancing a novel pipeline addressing large patient populations

Our platform capabilities have generated a pipeline of targeted radiopharmaceutical programs to address unmet needs in prevalent solid tumors.

Pipeline

Program	Target/Indication	Discovery	IND-enabling	Phase 1b	Phase 2/3	Upcoming Milestones
	Nectin-4 expressing solid tumors	Fast Track Designation				Ph1b ongoing Prelim data in 1Q’27
AKY-1189 was generated using our miniprotein radioconjugate platform and is designed to deliver actinium-225, a highly potent alpha-emitting radioisotope, to Nectin-4 expressing tumors. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to AKY-1189 for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have progressed on or after prior systemic therapies. We are currently conducting a multi-site Phase 1b study (NCT07020117) of AKY-1189 in the U.S. for the treatment of locally advanced or mUC, breast cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer.
	B7-H3 expressing mCRPC					Ph1b ongoing Prelim data in 2027
	B7-H3 expressing lung, colorectal, and other solid tumors					Ph1b start 2H’26
AKY-2519 was generated using our miniprotein radioconjugate platform and is designed to deliver actinium-225, a highly potent alpha-emitting radioisotope, to B7-H3 expressing tumors. We are currently conducting a multi-site Phase 1b trial of AKY-2519 ( NCT07581184) in the U.S. for the treatment of metastatic castration-resistance prostate cancer (mCRPC). We expect to initiate a Phase 1b basket trial of AKY-2519 for the treatment of lung, colorectal, and other solid tumor cancers in the second half of 2026.
Multiple Programs	Undisclosed
	Undisclosed

Presentations & Publications

05/30/2026

Poster Presentation at the Asco Annual Meeting Titled, “AKY-2519, a Novel B7-H3-targeted Radioconjugate, Demonstrates a Differentiated Biodistribution profile with low normal tissue exposure and robust tumor doses in patients with MCRPC”

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05/30/2026

Poster presentation at the ASCO Annual Meeting titled, “First-in-Human PET/CT Imaging With [68Ga]Ga-AKY-2519, a B7-H3-Targeted Miniprotein Radioconjugate, to Demonstrate Tumor Uptake and Normal Tissue Exposure Across Various Advanced Solid Tumors”

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02/27/2026

Poster presentation at the ASCO Genitourinary Cancers Symposium titled, “[225Ac]Ac-AKY-1189, a Nectin-4-Targeted Radiopharmaceutical, in Patients With Previously Treated Locally Advanced or Metastatic Solid Tumors: Phase 1b NECTINIUM-2 Study”

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10/25/2024

Oral Presentation at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics 2024 titled, “AKY-1189, a novel, ﬁrst-in-class miniprotein radiopharmaceutical designed to deliver Actinium-225 (225Ac) to Nectin-4 expressing tumors with broad therapeutic applications in metastatic urothelial carcinoma (mUC) and other Nectin-4 expressing tumors.”

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10/25/2024

Poster Presentation at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics 2024 titled, “Discovery and pre-clinical development of AKY-1189, a potent and selective Nectin-4 miniprotein binder optimized for use as a targeted radiopharmaceutical.”

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10/25/2024

Poster Presentation at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics 2024 titled, “Allometric scaling of preclinical dosimetry for the Nectin-4 miniprotein binders AKY-807 and AKY-1189 accurately predicts human absorbed dose to major organs.”

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