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

[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. (ASCO-GU 2026) - P1 | "Once RP2D is established, part 2 will evaluate the clinical activity of [225Ac]Ac-AKY-1189 in 3 cohorts of patients with Nectin-4 positive solid tumors. NECTINIUM-2 has started enrolling subjects in the United States."

Clinical • First-in-human • Metastases • P1 data • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer • NECTIN4

AKY-1189 highlights (GlobeNewswire) - "Continued to enroll patients in ongoing Phase 1b, multicenter, open-label NECTINIUM-2 clinical trial of AKY-1189 in patients with locally advanced or mUC, breast cancer, and other Nectin-4 expressing solid tumors....Expect preliminary data from the ongoing Phase 1b NECTINIUM-2 clinical trial in the first quarter of 2027."

Enrollment status • P1 data • Cervical Adenocarcinoma • Colorectal Adenocarcinoma • Head and Neck Cancer • Hormone Receptor Positive Breast Cancer • Non Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer

Aktis Oncology, Inc…announced that 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. - "Aktis is currently conducting a multi-site Phase 1b clinical trial (NCT07020117) of AKY-1189 in the United States for the treatment of locally advanced or mUC, breast cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer. Aktis expects to present preliminary results from Part 1 of the trial in the first quarter of 2027."

Fast track • P1 data • Urothelial Cancer

Enrolling patients in the ongoing Phase 1b clinical trial of AKY-1189 in patients with locally advanced or mUC, breast cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer (The Manila Times) - "Expect to report preliminary data from the Phase 1b trial in the first quarter of 2027."

Enrollment status • P1 data • Breast Cancer • Cervical Cancer • Colorectal Cancer • Head and Neck Cancer • Non Small Cell Lung Cancer • Urothelial Cancer

Anticipated key milestones for the next 12 months (GlobeNewswire) - "AKY-1189: Preliminary data from Part 1 of the ongoing Phase 1b clinical trial are expected in the first quarter of 2027."

P1 data • Cervical Cancer • Colorectal Adenocarcinoma • Head and Neck Cancer • Hormone Receptor Positive Breast Cancer • Non Small Cell Lung Cancer • Triple Negative Breast Cancer • Urothelial Cancer

Aktis is currently conducting a multi-site Phase 1b clinical trial (NCT07020117) of AKY-1189 in the United States for the treatment of locally advanced or mUC, breast cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer. (GlobeNewswire) - "Aktis expects to present preliminary results from Part 1 of the trial in the first quarter of 2027."

P1 data • Breast Cancer • Cervical Cancer • Colorectal Cancer • Head and Neck Cancer • Non Small Cell Lung Cancer • Urothelial Cancer

A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors (clinicaltrials.gov) - P1 | N=150 | Recruiting | Sponsor: Aktis Oncology, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Bladder Cancer • Breast Cancer • Cervical Adenocarcinoma • Cervical Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Head and Neck Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer

A Phase 1b Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors (clinicaltrials.gov) - P1 | N=150 | Not yet recruiting | Sponsor: Aktis Oncology, Inc.

New P1 trial • Bladder Cancer • Breast Cancer • Cervical Adenocarcinoma • Cervical Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Head and Neck Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer

AKTIS ONCOLOGY INITIATES PHASE 1B CLINICAL TRIAL OF ITS NECTIN-4-TARGETING RADIOPHARMACEUTICAL PRODUCT CANDIDATE, AKY-1189, ACROSS MULTIPLE TUMOR TYPES (PRNewswire) - "Aktis Oncology, Inc...today announced 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....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."

Trial status • Triple Negative Breast Cancer • Urothelial Cancer

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