[²²⁵Ac]Ac-AKY-1189 / Aktis Oncology - LARVOL DELTA

Allometric scaling of preclinical dosimetry for the Nectin-4 miniprotein binders AKY-807 and AKY-1189 accurately predicts human absorbed dose to major organs (EORTC-NCI-AACR 2024) - "Based on this translational evaluation, differences in preclinical scaled dosimetry for radiolabeled miniproteins appear useful for comparing compounds and predicting therapeutic indices in patients. Further studies with larger patient cohorts are essential to validate dosimetry findings and optimize treatment protocols to balance efficacy and safety."

Preclinical • Oncology • NECTIN4

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 (EORTC-NCI-AACR 2024) - "AKY-1189 is the first Nectin-4 targeted radiopharmaceutical to demonstrate substantial tumor uptake across several solid tumor types. These data support moving [225Ac]Ac-AKY-1189 into therapeutic clinical studies which are now initiated."

Metastases • Breast Cancer • Cervical Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer • NECTIN4

AKTIS ONCOLOGY ANNOUNCES PRESENTATION OF…DATA SUPPORTING BROAD DEVELOPMENT OF A FIRST IN CLASS NECTIN-4 TARGETING RADIOPHARMACEUTICAL AKY-1189 AT 2024 EORTC-NCI-AACR SYMPOSIUM ON MOLECULAR TARGETS AND CANCER THERAPEUTICS (PRNewswire) - "The first poster (Abstract no. 118), titled, 'Discovery and pre-clinical development of AKY-1189, a potent and selective Nectin-4 miniprotein binder optimized for use as a targeted radiopharmaceutical,' highlighted AKY-1189's preclinical data supporting advancement to clinical development. The second poster (Abstract no. 308), 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,' highlighted the accuracy of allometric scaling methods in predicting human organ dosimetry from preclinical data."

Preclinical • Oncology

Discovery and pre-clinical development of AKY-1189, a potent and selective Nectin-4 miniprotein binder optimized for use as a targeted radiopharmaceutical (EORTC-NCI-AACR 2024) - "[225Ac]Ac-AKY-1189 exhibits robust pre-clinical anti-tumor activity and target-dependent efficacy at well tolerated doses with a distinct improvement in renal uptake and retention compared to other molecules. AKY-1189 is currently progressing in human development as both an imaging and therapeutic agent."

Preclinical • Bladder Cancer • Cervical Cancer • Oncology • Solid Tumor • NECTIN4

AKTIS ONCOLOGY ANNOUNCES PRESENTATION OF THE FIRST CLINICAL DATA SUPPORTING BROAD DEVELOPMENT OF A FIRST IN CLASS NECTIN-4 TARGETING RADIOPHARMACEUTICAL AKY-1189 AT 2024 EORTC-NCI-AACR SYMPOSIUM ON MOLECULAR TARGETS AND CANCER THERAPEUTICS (PRNewswire) - P=NA | N=20 | "The plenary presentation (Abstract no. 10)...demonstrates a promising profile for AKY-1189 in patients with Nectin-4 expressing tumors. Pursuant to Section 21 guidelines of the South African Health Products Regulatory Authority (SAHPRA), 20 patients diagnosed with mUC, metastatic breast cancer, non-small cell lung cancer carcinoma, colorectal cancer and cervical cancer were imaged with [68Ga]Ga-AKY-1189 to address patient need. The resulting data were later assessed. A total of 15 patients were evaluable for biodistribution and tumor uptake analysis. Eight patients were dosed with [177Lu]Lu-AKY-1189 and were evaluable for kidney and bone marrow dosimetry. The assessment demonstrated AKY-1189 to be generally well tolerated with no treatment-emergent adverse events, and dosimetry analyses suggest a wide therapeutic index for [²²⁵Ac]Ac-AKY-1189. Significant tumor uptake of AKY-1189 was observed across primary and metastatic lesions..."

Clinical data • Breast Cancer • Cervical Cancer • Colorectal Cancer • Non Small Cell Lung Cancer • Urothelial Cancer