속보 • 15h
Aktis Oncology Unveils Encouraging AKY-2519 Data With Wider B7-H3 Trials Planned for 2026 Aktis Oncology reported first-in-human clinical imaging and dosimetry data for its AKY-2519 miniprotein radioconjugate targeting B7-H3-expressing tumors, showing robust tumor uptake with limited normal tissue exposure.
The company is running an ongoing Phase 1b trial of AKY-2519 in metastatic castration-resistant prostate cancer (mCRPC).
Aktis plans to start a separate Phase 1b trial for additional B7-H3-expressing tumors in the second half of 2026. The company will present the new data at the 2026 ASCO Annual Meeting, followed by a conference call with clinical investigators.
The early data readout for AKY-2519, together with multiple planned presentations and trials, highlights a concerted effort to build a broader clinical footprint around the B7-H3 target.
Investors may want to monitor the upcoming ASCO presentation and conference call, as further detail on safety, dosimetry and patient selection could influence expectations for how extensive the future development program may become. Reported Earnings • May 12
First quarter 2026 earnings: Revenues exceed analysts expectations while EPS lags behind First quarter 2026 results: US$0.38 loss per share. Net loss: US$18.3m (loss widened 52% from 1Q 2025). Revenue exceeded analyst estimates by 74%. Earnings per share (EPS) missed analyst estimates by 8.6%. Revenue is forecast to grow 54% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in the US. 공시 • May 06
Aktis Oncology Initiates Phase 1b Clinical Trial for AKY-2519, A B7-H3 Miniprotein Radioconjugate, In Metastatic Castration-Resistant Prostate Cancer Aktis Oncology, Inc. announced the initiation of a Phase 1b clinical trial of AKY-2519 in patients with metastatic castration-resistant prostate cancer (mCRPC). 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. The first Phase 1b open label trial will enroll patients with mCRPC, including both PLUVICTO-naïve and PLUVICTO-experienced cohorts, at multiple prostate-specific radioligand therapy centers in the U.S. The study will explore three dose levels in each cohort. Following dose escalation, the trial will expand enrollment at selected dose levels to generate additional clinical data. Preliminary data are expected in 2027. The second Phase 1b multi-center, open label trial will enroll patients in the U.S. with lung, colorectal, and other high B7-H3 expressing solid tumors. The protocol for this basket trial has been finalized and is currently under regulatory review. AKY-2519 is the second miniprotein Aktis has advanced to the clinic in the past 12 months. Aktis’ lead program, AKY-1189, a miniprotein radioconjugate protein targeting Nectin-4 expressing tumors, is currently enrolling patients in an ongoing Phase 1b trial, with preliminary data anticipated in the first quarter of 2027. 공시 • Apr 22
Aktis Oncology Inc Announces Clinical Imaging and Dosimetry Data for Aky-2519 Aktis Oncology, Inc. announced that clinical imaging and dosimetry data of AKY-2519 in patients with various B7-H3 expressing solid tumors will be presented in two poster presentations at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, being held May 29 – June 2, 2026, in Chicago. AKY-2519 is a miniprotein radioconjugate targeting B7-H3, which is expressed in several solid tumors, including prostate and lung cancers. In March 2026, the U.S. Food and Drug Administration (FDA) cleared Investigational New Drug (IND) applications for Aktis to proceed to a Phase 1b clinical trial with AKY-25191. AKY-2519 is the second clinical-stage miniprotein radioconjugate discovered using Aktis’ proprietary platform. The Company’s lead miniprotein radioconjugate, AKY-1189, targeting Nectin-4, is currently enrolling patients in a Phase 1b clinical trial. Aktis’ miniprotein radioconjugates are designed to selectively deliver actinium-225 (225Ac), a highly potent alpha-emitting radioisotope, to target-expressing tumors. Details of the ASCO presentations on AKY-2519 are as follows: Presentation Title: AKY-2519, a novel B7-H3–targeted radioconjugate, and its biodistribution profile in patients with mCRPC Date and Time: May 30, 1:30 p.m.- 4:30 p.m. CDT Poster Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology Poster #: 234 Abstract #: 3097 This normal tissue biodistribution and tumor uptake assessment through PET/CT imaging and normal tissues and tumor dosimetry analyses through sequential SPECT/CT imaging of patients with mCRPC was conducted at the Nuclear Medicine Research Infrastructure (NuMeRI), University of Pretoria and Steve Biko Academic Hospital, South Africa. Presentation Title: First-in-human PET/CT imaging with 68Ga-AKY-2519, a B7-H3 targeted miniprotein radioconjugate, to demonstrate tumor uptake and normal tissue exposure across various advanced solid tumors Date and Time: May 30, 1:30 p.m.- 4:30 p.m. CDT Poster Session: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology Poster #: 235 Abstract #: 3098 This normal tissue biodistribution and tumor uptake assessment through PET/CT imaging in various solid tumors was conducted at the Department of Nuclear Medicine, University of Duisburg-Essen and German Cancer Consortium (DKTK), Universitätsklinikum Essen (University Hospital Essen), Essen, Germany. Aktis has developed a proprietary, isotope-agnostic miniprotein radioconjugate platform to selectively deliver the tumor-killing properties of radioisotopes to targeted tumors. Aktis’ therapeutic miniprotein radioconjugates are designed to maximize anti-cancer activity through high tumor penetration coupled with internalization and retention in cancer cells, while rapidly clearing from normal organs and tissues. The Aktis platform further enables clinicians to visualize and verify target engagement with imaging isotopes prior to exposure to therapeutic radioisotopes. Leveraging this platform, and its patient-first end-to-end supply chain, Aktis is advancing a pipeline of next-generation targeted radiopharmaceuticals to address the unmet needs of patients across a broad spectrum of solid tumors. IND applications were cleared for [64Cu]Cu-AKY-2519 for imaging and [225Ac]Ac-AKY-2519 for therapeutic use. 공시 • Apr 16
Aktis Oncology, Inc. Announces Board Changes Aktis Oncology, Inc. announced the appointment of Glenn Gormley, MD, PhD, as an independent director to its Board of Directors and co-chair of the company’s newly established Science and Technology Committee of the Board of Directors. Dr. Gormley brings more than three decades of biopharmaceutical leadership across research and development, executive leadership, and board service. Most recently, Dr. Gormley served as Senior Executive Officer and Global Head of Research and Development at Daiichi Sankyo Co. Ltd., and as Executive Chairman and President of Daiichi Sankyo, Inc. In these roles, he led the global R&D strategy and oversaw the development of a broad and diversified pipeline, including the successful build-out of Daiichi Sankyo’s ADC platform. Prior to Daiichi Sankyo, Dr. Gormley held senior leadership positions at several global pharmaceutical companies. He served as Chief Medical Officer at AstraZeneca and as Global Head of Clinical Development and Medical Affairs at Novartis, where he led late-stage development and medical strategy across multiple programs. Earlier in his career, he held senior clinical development roles at Merck. Dr. Gormley holds an MD and a PhD from the University of Chicago and completed his training at UCLA and New York University leading to board certification in pediatrics and pediatric endocrinology. Concurrent with Dr. Gormley’s appointment to Aktis’ Board of Directors, current Board members Helen Kim and Oleg Nodelman plan to step down from Aktis’ Board of Directors, effective May 20, 2026. 
