[225Ac]Ac-AKY-2519 / Aktis Oncology - LARVOL DELTA

[225Ac]Ac-AKY-2519, a B7-H3-targeted radiopharmaceutical, in patients with metastatic castration-resistant prostate cancer: Phase 1b BActinium-1 study (ESMO 2026) - No abstract available

Clinical • Metastases • P1 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

AKY-2519 highlights (GlobeNewswire) - "Enrolling patients in Phase 1b, multicenter, open-label BActinium-1 clinical trial of AKY-2519 in PLUVICTO-naïve and -experienced patients with mCRPC....Expect to commence Phase 1b BActinium-2 basket trial in lung and other B7-H3 expressing solid tumor cancers in the second half of 2026. Expect preliminary data from Phase 1b mCRPC clinical trial in 2027."

New P1 trial • P1 data • Castration-Resistant Prostate Cancer • Lung Cancer • Solid Tumor

AKY-2519, a novel B7-H3-targeted radioconjugate, and its biodistribution profile in patients with mCRPC. (ASCO 2026) - "These are the first clinical data showing concordance between PSMA and B7-H3 on PET-CT imaging in a substantial cohort of patients supporting B7-H3 as a novel target in mCRPC. The normal tissue to tumor dose ratios observed with AKY-2519 suggest a wide therapeutic window as an Ac-225 delivering therapeutic. The low predicted dose to salivary glands supports its use as an actinium delivering RCT for mCRPC, with dosing under IND expected to start in 2H-2026."

Clinical • Castration-Resistant Prostate Cancer • Prostate Cancer • CD276

Aktis Oncology Reports First-in-Human Clinical Imaging and Dosimetry Data for AKY-2519 Demonstrating Robust Tumor Uptake and Limited Normal Tissue Exposures in Patients with B7-H3 Expressing Tumors (GlobeNewswire) - "Combined results evaluating AKY-2519 across several B7-H3 expressing tumor types, including metastatic castration-resistant prostate cancer (mCRPC), suggest a potentially differentiated profile compared to approved radiopharmaceuticals....Aktis is currently enrolling patients in an mCRPC-dedicated Phase 1b trial of AKY-2519 in PLUVICTO\-naïve and PLUVICTO-experienced patients, with preliminary data anticipated in 2027. The Company is on track to initiate a second Phase 1b trial of AKY-2519 in other B7-H3 expressing solid tumors in the second half of 2026."

First-in-human • P1 data • Trial status • Castration-Resistant Prostate Cancer • Solid Tumor

BActinium-1: A Study of [225Ac]Ac-AKY-2519 in Patients With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=138 | Recruiting | Sponsor: Aktis Oncology, Inc.

New P1 trial • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Aktis Oncology Initiates Phase 1b Clinical Trial for AKY-2519, a B7-H3 Miniprotein Radioconjugate, in Metastatic Castration-Resistant Prostate Cancer (mCRPC) (GlobeNewswire) - "The mCRPC-dedicated Phase 1b trial is part of Aktis’ clinical development strategy to develop AKY-2519 broadly in B7-H3 expressing tumors. Aktis plans to initiate a Phase 1b basket trial in lung, colorectal, and other high B7-H3 expressing solid tumors in the second half of 2026....Following dose escalation, the trial will expand enrollment at selected dose levels to generate additional clinical data. Preliminary data are expected in 2027."

New P1 trial • P1 data • Trial status • Castration-Resistant Prostate Cancer • Colorectal Cancer • Non Small Cell Lung Cancer

Aktis Oncology Announces Presentation of First Clinical Imaging and Dosimetry Data for AKY-2519 at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting (The Manila Times) - "Data facilitate initial understanding of AKY-2519 biodistribution and predicted absorbed doses in tumors and normal tissues in patients with B7-H3 expressing solid tumors; Phase 1b clinical trial of AKY-2519 to start mid-2026."

Clinical data • First-in-human • New P1 trial • Castration-Resistant Prostate Cancer

Aktis Oncology…announced the U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) applications for the Company to proceed to a Phase 1b clinical trial with AKY-2519 (GlobeNewswire) - "AKY-2519 is a miniprotein radioconjugate targeting B7-H3, which is expressed in several solid tumor types including prostate and lung cancers....Anticipated key milestones for the next 12 months:... (i) Results from clinical imaging and dosimetry assessment of AKY-2519 in patients with various solid tumors are expected in mid-2026; (ii) Phase 1b clinical trial is expected to commence in mid-2026. The Company plans to provide further details on the overall clinical development strategy of AKY-2519 at that time."

Clinical data • IND • New P1 trial • Non Small Cell Lung Cancer • Prostate Cancer